Women's Health

Here is our problem: Family medicine has allowed itself, and its patients, to be picked apart by the forces of reductionism and a system that profits from the sick and suffering. We have lost sight of our purpose and our vision to care for the whole person. We have lost our way as healers.

The result is not only a decline in the specialty of family medicine as a leader in primary care but declining value and worsening outcomes in health care overall. We need to get our mojo back. We can do this by focusing less on trying to be all things to all people at all times, and more on creating better models for preventing, managing, and reversing chronic disease. This means providing health care that is person centered, relationship based, recovery focused, and paid for comprehensively.

I call this model Advanced Primary Care, or APC ­(FIGURE). In this article, I describe exemplars of APC from across the United States. I also provide tools to help you recover its central feature, holism—care of the whole person in mind, body, community, and spirit—in your practice, thus returning us to the core purpose of family medicine.

Holism is central to family medicine

More than 40 years ago, psychiatrist George Engel, MD, published a seminal article in Science that inspired a radical vision of how health care should be practiced.¹ Called the biopsychosocial model, it stated what, in some ways, is obvious: Human beings are complex organisms embedded in complex environments made up of distinct, yet interacting, dimensions. These dimensions included physical, psychological, and social components. Engel’s radical proposition was that these dimensions are definable and measurable and that good medicine cannot afford to ignore any of them.

Engel’s assertion that good medicine requires holism was a clarion call during a time of rapidly expanding knowledge and subspecialization. That call was the inspiration for a new medical specialty called family medicine, which dared to proclaim that the best way to heal was to care for the whole person within the context of that person’s emotional and social environment. Family medicine reinvigorated primary care and grew rapidly, becoming a preeminent primary care specialty in the United States.

Continue to : Reductionism is relentless

Reductionism is relentless

But the forces of medicine were—and still are—driving relentlessly the other way. The science of the small and particular (reductionism), with dazzling technology and exploding subspecialty knowledge, and backed by powerful economic drivers, rewards health care for pulling the patient and the medical profession apart. We pay more to those who treat small parts of a person over a short period than to those who attend to the whole person over the lifetime.

Today, family medicine—for all of its common sense, scientific soundness, connectedness to patients, and demonstrated value—struggles to survive.^2-6 The holistic vision of Engel is declining. The struggle in primary care is that its holistic vision gets co-opted by specialized medical science—and then it desperately attempts to apply those small and specialized tools to the care of patients in their wholeness. Holism is largely dead in health care, and everyone pays the consequences.⁷

Health care is losing its value

The damage from this decline in holism is not just to primary care but to the value of health care in general. Most medical care being delivered today—comprising diagnosis, treatment, and payment (the innermost circle of the FIGURE)—is not producing good health.⁸ Only 15% to 20% of the healing of an individual or a population comes from health care.⁹ The rest—nearly 80%—comes from other factors rarely addressed in the health care system: behavioral and lifestyle choices that people make in their daily life, including those related to food, movement, sleep, stress, and substance use.¹⁰ Increasingly, it is the economic and social determinants of health that influence this behavior and have a greater impact on health and lifespan than physiology or genes.¹¹ The same social determinants of health also influence patients’ ability to obtain medical care and pursue a meaningful life.¹²

The result of this decline in holism and in the value of health care in general has been a relentless rise in the cost of medical care^13-15 and the need for social services; declining life expectancy^16,17 and quality of life¹⁸; growing patient dissatisfaction; and burnout in providers.^19,20 Health care has become, as investor and business leader Warren Buffet remarked, the “tapeworm” of the economy and a major contributor to growing disparities in health and well-being between the haves and have-nots.²¹ Engel’s prediction that good medicine cannot afford to ignore holism has come to pass.

Family medicine has allowed itself, and patients, to be picked apart by forces of reductionism and a system that profits from the sick and suffering.

3-step solution:Return to whole-person care

Family medicine needs to return to whole-person care, but it can do so only if it attends to, and effectively delivers on, the prevention, treatment, and reversal of chronic disease and the enhancement of health and well-­being. This can happen only if family medicine stops trying to be all things to all people at all times and, instead, focuses on what matters to the patient as a person.

Continue to: This means that the core...

This means that the core interaction in family medicine must be to assess the whole person—mind, body, social, spirit—and help that person make changes that improve his/her/their health and well-being based on his/her/their individualized needs and social context. In other words, family medicine needs to deliver a holistic model of APC that is person centered, relationship based, recovery focused, and paid for comprehensively.

How does one get from “standard” primary care of today (the innermost circle of the FIGURE) to a framework that truly delivers on the promise of healing? I propose 3 steps to return holism to family medicine.

STEP 1: Start with comprehensive, coordinated primary care. We know that this works. Starfield and others demonstrated this 2 decades ago, defining and devising what we know as quality primary care—characterized by first-contact care, comprehensive primary care (CPC), continuous care, and coordinated care.²² This type of primary care improves outcomes, lowers costs, and is satisfying to patients and providers.²³ The physician cares for the patient throughout that person’s entire life cycle and provides all evidence-based services needed to prevent and treat common conditions. Comprehensive primary care is positioned in the first circle outward from the innermost circle of the FIGURE.

As medicine has become increasingly complex and subspecialized, however, the ability to coordinate care is often frayed, adding cost and reducing quality.^24-26 Today, comprehensive primary care needs enhanced coordination. At a minimum, this means coordinating services for:

• chronic disease management (outpatient and inpatient transitions and emergency department use)
• referral (specialists and tests)
• pharmacy services (including delivery and patient education support).

An example of a primary care system that meets these requirements is the Catalyst Health Network in central Texas, which supplies coordination services to more than 1000 comprehensive primary care practices and 1.5 million patients.²⁷ The Catalyst Network makes money for those practices, saves money in the system, enhances patient and provider satisfaction, and improves population health in the community.²⁷ I call this enhanced primary care (EPC), shown in the second circle out from the innermost circle of the FIGURE.

STEP 2: Add integrative medicine and mental health. EPC improves fragmented care but does not necessarily address a patient’s underlying determinants of healing. We know that health behaviors such as smoking cessation, avoidance of alcohol and drug abuse, improved diet, physical activity, sleep, and stress management contribute 40% to 60% of a person’s and a population’s health.¹⁰ In addition, evidence shows that behavioral health services, along with lifestyle change support, can even reverse many chronic diseases seen in primary care, such as obesity, diabetes, hypertension, cardiovascular disease, depression, and substance abuse.^28,29

Continue to: Therefore, we need to add...

Therefore, we need to add routine mental health services and nonpharmacotherapeutic approaches (eg, complementary and alternative medicine) to primary care.³⁰ Doing so requires that behavioral change and self-care become a central feature of the ­doctor–patient dialogue and team skills³¹ and be added to primary care.^30,31 I call this integrative primary care (IPC), shown on the left side in the third circle out from the innermost circle of the FIGURE.
 

Only 15% to 20% of individual and population healing comes from health care; the rest, from behavioral and lifestyle choices rarely addressed in primary care.

An example of IPC is Whole Health, an initiative of the US Veteran’s Health Administration. Whole Health empowers and informs a person-centered approach and integrates it into the delivery of routine care.³² Evaluation of Whole Health implementation, which involved more than 130,000 veterans followed for 2 years, found a net overall reduction in the total cost of care of 20%—saving nearly $650 million or, on average, more than $4500 per veteran.³³

STEP 3: Address social determinants of health. Primary care will not fully be part of the solution for producing health and well-being unless it becomes instrumental in addressing the social determinants of health (SDH), defined as “… conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.”³⁴ These determinants include not only basic needs, such as housing, food, safety, and transportation (ie, social needs), but also what are known as structural determinants, such as income, education, language, and racial and ethnic bias. Health care cannot solve all of these social ills,but it is increasingly being called on to be the nexus of coordination for services that address these needs when they affect health outcomes.^35,36

Examples of health systems that provide for social needs include the free “food prescription” program of Pennsylvania’s Geisinger Health System, for patients with diabetes who do not have the resources to pay for food.³⁷ This approach improves blood glucose control by patients and saves money on medications and other interventions. Similarly, Kaiser Permanente has experimented with housing vouchers for homeless patients,and most Federally Qualified Health Centers provide bus or other transportation tickets to patients for their appointments and free or discounted tests and specialty care.³⁸

Implementing whole-person care for all

I propose that we make APC the central focus of family medicine. This model would comprise CPC, plus EPC, IPC, and community coordination to address SDH. This is expressed as:

CPC + EPC + IPC + SDH = APC

Continue to: APC would mean...

APC would mean health for the whole person and for all people. Again, the FIGURE shows how this model, encompassing the entire third circle out from the center circle, could be created from current models of care.

How do we pay for this? We already do—and way too much. The problem is not lack of money in the health care system but how it is organized and distributed. The Centers for Medicare and Medicaid Services and other payers are developing value-based payment models to help cover this type of care,³⁹ but payers cannot pay for something if it is unavailable.

Can family physicians deliver APC? I believe they can, and have given a few examples here to show how this is already happening. To help primary care providers start to deliver APC in their system, my team and I have built the HOPE (Healing Oriented Practices & Environments) Note Toolkit to use in daily practice.⁴⁰ These and other tools are being used by a number of large hospital systems and health care networks around the country. (You can download the HOPE Note Toolkit, at no cost, at https://drwaynejonas.com/­resources/hope-note/.)

At a minimum, comprehensive primary care needs to coordinate services for chronic disease management, referral (to specialists and testing), and pharmacy services.

Whatever we call this new type of primary care, it needs to care for the whole person and to be available to all. It finds expression in these assertions:

• We cannot ignore an essential part of what a human being is and expect them to heal or become whole.
• We cannot ignore essential people in our communities and expect our costs to go down or our compassion to go up.
• We need to stop allowing family medicine to be co-opted by reductionism and its profits.

In sum, we need a new vision of primary care—like Engel’s holistic vision in the 1970s—to motivate us, and we need to return to fundamental concepts of how healing works in medicine.⁴¹

CORRESPONDENCE

Wayne B. Jonas, MD, Samueli Integrative Health Programs, 1800 Diagonal Road, Suite 617, Alexandria, VA 22314; wayne@drwaynejonas.com.

Here is our problem: Family medicine has allowed itself, and its patients, to be picked apart by the forces of reductionism and a system that profits from the sick and suffering. We have lost sight of our purpose and our vision to care for the whole person. We have lost our way as healers.

The result is not only a decline in the specialty of family medicine as a leader in primary care but declining value and worsening outcomes in health care overall. We need to get our mojo back. We can do this by focusing less on trying to be all things to all people at all times, and more on creating better models for preventing, managing, and reversing chronic disease. This means providing health care that is person centered, relationship based, recovery focused, and paid for comprehensively.

I call this model Advanced Primary Care, or APC ­(FIGURE). In this article, I describe exemplars of APC from across the United States. I also provide tools to help you recover its central feature, holism—care of the whole person in mind, body, community, and spirit—in your practice, thus returning us to the core purpose of family medicine.

Holism is central to family medicine

More than 40 years ago, psychiatrist George Engel, MD, published a seminal article in Science that inspired a radical vision of how health care should be practiced.¹ Called the biopsychosocial model, it stated what, in some ways, is obvious: Human beings are complex organisms embedded in complex environments made up of distinct, yet interacting, dimensions. These dimensions included physical, psychological, and social components. Engel’s radical proposition was that these dimensions are definable and measurable and that good medicine cannot afford to ignore any of them.

Engel’s assertion that good medicine requires holism was a clarion call during a time of rapidly expanding knowledge and subspecialization. That call was the inspiration for a new medical specialty called family medicine, which dared to proclaim that the best way to heal was to care for the whole person within the context of that person’s emotional and social environment. Family medicine reinvigorated primary care and grew rapidly, becoming a preeminent primary care specialty in the United States.

Continue to : Reductionism is relentless

Reductionism is relentless

But the forces of medicine were—and still are—driving relentlessly the other way. The science of the small and particular (reductionism), with dazzling technology and exploding subspecialty knowledge, and backed by powerful economic drivers, rewards health care for pulling the patient and the medical profession apart. We pay more to those who treat small parts of a person over a short period than to those who attend to the whole person over the lifetime.

Today, family medicine—for all of its common sense, scientific soundness, connectedness to patients, and demonstrated value—struggles to survive.^2-6 The holistic vision of Engel is declining. The struggle in primary care is that its holistic vision gets co-opted by specialized medical science—and then it desperately attempts to apply those small and specialized tools to the care of patients in their wholeness. Holism is largely dead in health care, and everyone pays the consequences.⁷

Health care is losing its value

The damage from this decline in holism is not just to primary care but to the value of health care in general. Most medical care being delivered today—comprising diagnosis, treatment, and payment (the innermost circle of the FIGURE)—is not producing good health.⁸ Only 15% to 20% of the healing of an individual or a population comes from health care.⁹ The rest—nearly 80%—comes from other factors rarely addressed in the health care system: behavioral and lifestyle choices that people make in their daily life, including those related to food, movement, sleep, stress, and substance use.¹⁰ Increasingly, it is the economic and social determinants of health that influence this behavior and have a greater impact on health and lifespan than physiology or genes.¹¹ The same social determinants of health also influence patients’ ability to obtain medical care and pursue a meaningful life.¹²

The result of this decline in holism and in the value of health care in general has been a relentless rise in the cost of medical care^13-15 and the need for social services; declining life expectancy^16,17 and quality of life¹⁸; growing patient dissatisfaction; and burnout in providers.^19,20 Health care has become, as investor and business leader Warren Buffet remarked, the “tapeworm” of the economy and a major contributor to growing disparities in health and well-being between the haves and have-nots.²¹ Engel’s prediction that good medicine cannot afford to ignore holism has come to pass.

Family medicine has allowed itself, and patients, to be picked apart by forces of reductionism and a system that profits from the sick and suffering.

3-step solution:Return to whole-person care

Family medicine needs to return to whole-person care, but it can do so only if it attends to, and effectively delivers on, the prevention, treatment, and reversal of chronic disease and the enhancement of health and well-­being. This can happen only if family medicine stops trying to be all things to all people at all times and, instead, focuses on what matters to the patient as a person.

Continue to: This means that the core...

This means that the core interaction in family medicine must be to assess the whole person—mind, body, social, spirit—and help that person make changes that improve his/her/their health and well-being based on his/her/their individualized needs and social context. In other words, family medicine needs to deliver a holistic model of APC that is person centered, relationship based, recovery focused, and paid for comprehensively.

How does one get from “standard” primary care of today (the innermost circle of the FIGURE) to a framework that truly delivers on the promise of healing? I propose 3 steps to return holism to family medicine.

STEP 1: Start with comprehensive, coordinated primary care. We know that this works. Starfield and others demonstrated this 2 decades ago, defining and devising what we know as quality primary care—characterized by first-contact care, comprehensive primary care (CPC), continuous care, and coordinated care.²² This type of primary care improves outcomes, lowers costs, and is satisfying to patients and providers.²³ The physician cares for the patient throughout that person’s entire life cycle and provides all evidence-based services needed to prevent and treat common conditions. Comprehensive primary care is positioned in the first circle outward from the innermost circle of the FIGURE.

As medicine has become increasingly complex and subspecialized, however, the ability to coordinate care is often frayed, adding cost and reducing quality.^24-26 Today, comprehensive primary care needs enhanced coordination. At a minimum, this means coordinating services for:

• chronic disease management (outpatient and inpatient transitions and emergency department use)
• referral (specialists and tests)
• pharmacy services (including delivery and patient education support).

An example of a primary care system that meets these requirements is the Catalyst Health Network in central Texas, which supplies coordination services to more than 1000 comprehensive primary care practices and 1.5 million patients.²⁷ The Catalyst Network makes money for those practices, saves money in the system, enhances patient and provider satisfaction, and improves population health in the community.²⁷ I call this enhanced primary care (EPC), shown in the second circle out from the innermost circle of the FIGURE.

STEP 2: Add integrative medicine and mental health. EPC improves fragmented care but does not necessarily address a patient’s underlying determinants of healing. We know that health behaviors such as smoking cessation, avoidance of alcohol and drug abuse, improved diet, physical activity, sleep, and stress management contribute 40% to 60% of a person’s and a population’s health.¹⁰ In addition, evidence shows that behavioral health services, along with lifestyle change support, can even reverse many chronic diseases seen in primary care, such as obesity, diabetes, hypertension, cardiovascular disease, depression, and substance abuse.^28,29

Continue to: Therefore, we need to add...

Therefore, we need to add routine mental health services and nonpharmacotherapeutic approaches (eg, complementary and alternative medicine) to primary care.³⁰ Doing so requires that behavioral change and self-care become a central feature of the ­doctor–patient dialogue and team skills³¹ and be added to primary care.^30,31 I call this integrative primary care (IPC), shown on the left side in the third circle out from the innermost circle of the FIGURE.
 

Only 15% to 20% of individual and population healing comes from health care; the rest, from behavioral and lifestyle choices rarely addressed in primary care.

An example of IPC is Whole Health, an initiative of the US Veteran’s Health Administration. Whole Health empowers and informs a person-centered approach and integrates it into the delivery of routine care.³² Evaluation of Whole Health implementation, which involved more than 130,000 veterans followed for 2 years, found a net overall reduction in the total cost of care of 20%—saving nearly $650 million or, on average, more than $4500 per veteran.³³

STEP 3: Address social determinants of health. Primary care will not fully be part of the solution for producing health and well-being unless it becomes instrumental in addressing the social determinants of health (SDH), defined as “… conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.”³⁴ These determinants include not only basic needs, such as housing, food, safety, and transportation (ie, social needs), but also what are known as structural determinants, such as income, education, language, and racial and ethnic bias. Health care cannot solve all of these social ills,but it is increasingly being called on to be the nexus of coordination for services that address these needs when they affect health outcomes.^35,36

Examples of health systems that provide for social needs include the free “food prescription” program of Pennsylvania’s Geisinger Health System, for patients with diabetes who do not have the resources to pay for food.³⁷ This approach improves blood glucose control by patients and saves money on medications and other interventions. Similarly, Kaiser Permanente has experimented with housing vouchers for homeless patients,and most Federally Qualified Health Centers provide bus or other transportation tickets to patients for their appointments and free or discounted tests and specialty care.³⁸

Implementing whole-person care for all

I propose that we make APC the central focus of family medicine. This model would comprise CPC, plus EPC, IPC, and community coordination to address SDH. This is expressed as:

CPC + EPC + IPC + SDH = APC

Continue to: APC would mean...

APC would mean health for the whole person and for all people. Again, the FIGURE shows how this model, encompassing the entire third circle out from the center circle, could be created from current models of care.

How do we pay for this? We already do—and way too much. The problem is not lack of money in the health care system but how it is organized and distributed. The Centers for Medicare and Medicaid Services and other payers are developing value-based payment models to help cover this type of care,³⁹ but payers cannot pay for something if it is unavailable.

Can family physicians deliver APC? I believe they can, and have given a few examples here to show how this is already happening. To help primary care providers start to deliver APC in their system, my team and I have built the HOPE (Healing Oriented Practices & Environments) Note Toolkit to use in daily practice.⁴⁰ These and other tools are being used by a number of large hospital systems and health care networks around the country. (You can download the HOPE Note Toolkit, at no cost, at https://drwaynejonas.com/­resources/hope-note/.)

At a minimum, comprehensive primary care needs to coordinate services for chronic disease management, referral (to specialists and testing), and pharmacy services.

Whatever we call this new type of primary care, it needs to care for the whole person and to be available to all. It finds expression in these assertions:

• We cannot ignore an essential part of what a human being is and expect them to heal or become whole.
• We cannot ignore essential people in our communities and expect our costs to go down or our compassion to go up.
• We need to stop allowing family medicine to be co-opted by reductionism and its profits.

In sum, we need a new vision of primary care—like Engel’s holistic vision in the 1970s—to motivate us, and we need to return to fundamental concepts of how healing works in medicine.⁴¹

CORRESPONDENCE

Wayne B. Jonas, MD, Samueli Integrative Health Programs, 1800 Diagonal Road, Suite 617, Alexandria, VA 22314; wayne@drwaynejonas.com.

Here is our problem: Family medicine has allowed itself, and its patients, to be picked apart by the forces of reductionism and a system that profits from the sick and suffering. We have lost sight of our purpose and our vision to care for the whole person. We have lost our way as healers.

The result is not only a decline in the specialty of family medicine as a leader in primary care but declining value and worsening outcomes in health care overall. We need to get our mojo back. We can do this by focusing less on trying to be all things to all people at all times, and more on creating better models for preventing, managing, and reversing chronic disease. This means providing health care that is person centered, relationship based, recovery focused, and paid for comprehensively.

I call this model Advanced Primary Care, or APC ­(FIGURE). In this article, I describe exemplars of APC from across the United States. I also provide tools to help you recover its central feature, holism—care of the whole person in mind, body, community, and spirit—in your practice, thus returning us to the core purpose of family medicine.

Holism is central to family medicine

More than 40 years ago, psychiatrist George Engel, MD, published a seminal article in Science that inspired a radical vision of how health care should be practiced.¹ Called the biopsychosocial model, it stated what, in some ways, is obvious: Human beings are complex organisms embedded in complex environments made up of distinct, yet interacting, dimensions. These dimensions included physical, psychological, and social components. Engel’s radical proposition was that these dimensions are definable and measurable and that good medicine cannot afford to ignore any of them.

Engel’s assertion that good medicine requires holism was a clarion call during a time of rapidly expanding knowledge and subspecialization. That call was the inspiration for a new medical specialty called family medicine, which dared to proclaim that the best way to heal was to care for the whole person within the context of that person’s emotional and social environment. Family medicine reinvigorated primary care and grew rapidly, becoming a preeminent primary care specialty in the United States.

Continue to : Reductionism is relentless

Reductionism is relentless

But the forces of medicine were—and still are—driving relentlessly the other way. The science of the small and particular (reductionism), with dazzling technology and exploding subspecialty knowledge, and backed by powerful economic drivers, rewards health care for pulling the patient and the medical profession apart. We pay more to those who treat small parts of a person over a short period than to those who attend to the whole person over the lifetime.

Today, family medicine—for all of its common sense, scientific soundness, connectedness to patients, and demonstrated value—struggles to survive.^2-6 The holistic vision of Engel is declining. The struggle in primary care is that its holistic vision gets co-opted by specialized medical science—and then it desperately attempts to apply those small and specialized tools to the care of patients in their wholeness. Holism is largely dead in health care, and everyone pays the consequences.⁷

Health care is losing its value

The damage from this decline in holism is not just to primary care but to the value of health care in general. Most medical care being delivered today—comprising diagnosis, treatment, and payment (the innermost circle of the FIGURE)—is not producing good health.⁸ Only 15% to 20% of the healing of an individual or a population comes from health care.⁹ The rest—nearly 80%—comes from other factors rarely addressed in the health care system: behavioral and lifestyle choices that people make in their daily life, including those related to food, movement, sleep, stress, and substance use.¹⁰ Increasingly, it is the economic and social determinants of health that influence this behavior and have a greater impact on health and lifespan than physiology or genes.¹¹ The same social determinants of health also influence patients’ ability to obtain medical care and pursue a meaningful life.¹²

The result of this decline in holism and in the value of health care in general has been a relentless rise in the cost of medical care^13-15 and the need for social services; declining life expectancy^16,17 and quality of life¹⁸; growing patient dissatisfaction; and burnout in providers.^19,20 Health care has become, as investor and business leader Warren Buffet remarked, the “tapeworm” of the economy and a major contributor to growing disparities in health and well-being between the haves and have-nots.²¹ Engel’s prediction that good medicine cannot afford to ignore holism has come to pass.

Family medicine has allowed itself, and patients, to be picked apart by forces of reductionism and a system that profits from the sick and suffering.

3-step solution:Return to whole-person care

Family medicine needs to return to whole-person care, but it can do so only if it attends to, and effectively delivers on, the prevention, treatment, and reversal of chronic disease and the enhancement of health and well-­being. This can happen only if family medicine stops trying to be all things to all people at all times and, instead, focuses on what matters to the patient as a person.

Continue to: This means that the core...

This means that the core interaction in family medicine must be to assess the whole person—mind, body, social, spirit—and help that person make changes that improve his/her/their health and well-being based on his/her/their individualized needs and social context. In other words, family medicine needs to deliver a holistic model of APC that is person centered, relationship based, recovery focused, and paid for comprehensively.

How does one get from “standard” primary care of today (the innermost circle of the FIGURE) to a framework that truly delivers on the promise of healing? I propose 3 steps to return holism to family medicine.

STEP 1: Start with comprehensive, coordinated primary care. We know that this works. Starfield and others demonstrated this 2 decades ago, defining and devising what we know as quality primary care—characterized by first-contact care, comprehensive primary care (CPC), continuous care, and coordinated care.²² This type of primary care improves outcomes, lowers costs, and is satisfying to patients and providers.²³ The physician cares for the patient throughout that person’s entire life cycle and provides all evidence-based services needed to prevent and treat common conditions. Comprehensive primary care is positioned in the first circle outward from the innermost circle of the FIGURE.

As medicine has become increasingly complex and subspecialized, however, the ability to coordinate care is often frayed, adding cost and reducing quality.^24-26 Today, comprehensive primary care needs enhanced coordination. At a minimum, this means coordinating services for:

• chronic disease management (outpatient and inpatient transitions and emergency department use)
• referral (specialists and tests)
• pharmacy services (including delivery and patient education support).

An example of a primary care system that meets these requirements is the Catalyst Health Network in central Texas, which supplies coordination services to more than 1000 comprehensive primary care practices and 1.5 million patients.²⁷ The Catalyst Network makes money for those practices, saves money in the system, enhances patient and provider satisfaction, and improves population health in the community.²⁷ I call this enhanced primary care (EPC), shown in the second circle out from the innermost circle of the FIGURE.

STEP 2: Add integrative medicine and mental health. EPC improves fragmented care but does not necessarily address a patient’s underlying determinants of healing. We know that health behaviors such as smoking cessation, avoidance of alcohol and drug abuse, improved diet, physical activity, sleep, and stress management contribute 40% to 60% of a person’s and a population’s health.¹⁰ In addition, evidence shows that behavioral health services, along with lifestyle change support, can even reverse many chronic diseases seen in primary care, such as obesity, diabetes, hypertension, cardiovascular disease, depression, and substance abuse.^28,29

Continue to: Therefore, we need to add...

Therefore, we need to add routine mental health services and nonpharmacotherapeutic approaches (eg, complementary and alternative medicine) to primary care.³⁰ Doing so requires that behavioral change and self-care become a central feature of the ­doctor–patient dialogue and team skills³¹ and be added to primary care.^30,31 I call this integrative primary care (IPC), shown on the left side in the third circle out from the innermost circle of the FIGURE.
 

Only 15% to 20% of individual and population healing comes from health care; the rest, from behavioral and lifestyle choices rarely addressed in primary care.

An example of IPC is Whole Health, an initiative of the US Veteran’s Health Administration. Whole Health empowers and informs a person-centered approach and integrates it into the delivery of routine care.³² Evaluation of Whole Health implementation, which involved more than 130,000 veterans followed for 2 years, found a net overall reduction in the total cost of care of 20%—saving nearly $650 million or, on average, more than $4500 per veteran.³³

STEP 3: Address social determinants of health. Primary care will not fully be part of the solution for producing health and well-being unless it becomes instrumental in addressing the social determinants of health (SDH), defined as “… conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.”³⁴ These determinants include not only basic needs, such as housing, food, safety, and transportation (ie, social needs), but also what are known as structural determinants, such as income, education, language, and racial and ethnic bias. Health care cannot solve all of these social ills,but it is increasingly being called on to be the nexus of coordination for services that address these needs when they affect health outcomes.^35,36

Examples of health systems that provide for social needs include the free “food prescription” program of Pennsylvania’s Geisinger Health System, for patients with diabetes who do not have the resources to pay for food.³⁷ This approach improves blood glucose control by patients and saves money on medications and other interventions. Similarly, Kaiser Permanente has experimented with housing vouchers for homeless patients,and most Federally Qualified Health Centers provide bus or other transportation tickets to patients for their appointments and free or discounted tests and specialty care.³⁸

Implementing whole-person care for all

I propose that we make APC the central focus of family medicine. This model would comprise CPC, plus EPC, IPC, and community coordination to address SDH. This is expressed as:

CPC + EPC + IPC + SDH = APC

Continue to: APC would mean...

APC would mean health for the whole person and for all people. Again, the FIGURE shows how this model, encompassing the entire third circle out from the center circle, could be created from current models of care.

How do we pay for this? We already do—and way too much. The problem is not lack of money in the health care system but how it is organized and distributed. The Centers for Medicare and Medicaid Services and other payers are developing value-based payment models to help cover this type of care,³⁹ but payers cannot pay for something if it is unavailable.

Can family physicians deliver APC? I believe they can, and have given a few examples here to show how this is already happening. To help primary care providers start to deliver APC in their system, my team and I have built the HOPE (Healing Oriented Practices & Environments) Note Toolkit to use in daily practice.⁴⁰ These and other tools are being used by a number of large hospital systems and health care networks around the country. (You can download the HOPE Note Toolkit, at no cost, at https://drwaynejonas.com/­resources/hope-note/.)

At a minimum, comprehensive primary care needs to coordinate services for chronic disease management, referral (to specialists and testing), and pharmacy services.

Whatever we call this new type of primary care, it needs to care for the whole person and to be available to all. It finds expression in these assertions:

• We cannot ignore an essential part of what a human being is and expect them to heal or become whole.
• We cannot ignore essential people in our communities and expect our costs to go down or our compassion to go up.
• We need to stop allowing family medicine to be co-opted by reductionism and its profits.

In sum, we need a new vision of primary care—like Engel’s holistic vision in the 1970s—to motivate us, and we need to return to fundamental concepts of how healing works in medicine.⁴¹

CORRESPONDENCE

Wayne B. Jonas, MD, Samueli Integrative Health Programs, 1800 Diagonal Road, Suite 617, Alexandria, VA 22314; wayne@drwaynejonas.com.

CASE 

Mr. A is a 30-year-old man with neurofibromatosis and myelopathy with associated quadriplegia, complicated by dysphasia and chronic hypercapnic respiratory failure requiring a tracheostomy. He is cared for at home by his very competent mother but requires regular visits with his medical providers for assistance with his complex care needs. Due to logistical challenges, he had been receiving regular home visits even before the ­COVID-19 pandemic.

After estimating the risk of exposure to the patient, Mr. A’s family and his physician’s office staff scheduled a home visit. Before the appointment, the doctor conducted a virtual visit with the patient and family members to screen for COVID-19 infection, which proved negative. The doctor arranged a visit to coincide with Mr. A’s regular appointment with the home health nurse. He invited the patient’s social worker to attend, as well.

The providers donned masks, face shields, and gloves before entering the home. Mr. A’s temperature was checked and was normal. The team completed a physical exam, assessed the patient’s current needs, and refilled prescriptions. The doctor, nurse, and social worker met afterward in the family’s driveway to coordinate plans for the patient’s future care.

This encounter allowed a vulnerable patient with special needs to have access to care while reducing his risk of undesirable exposure. Also, his health care team’s provision of care in the home setting reduced Mr. A’s anxiety and that of his family members.

Home visits have long been an integral part of what it means to be a family physician. In 1930, roughly 40% of all patient-physician encounters in the United States occurred in patients’ homes. By 1980, this number had dropped to < 1%.¹ Still, a 1994 survey of American doctors in 3 primary care specialties revealed that 63% of family physicians, more than the other 2 specialties, still made house calls.² A 2016 analysis of Medicare claims data showed that between 2006 and 2011, only 5% of American doctors overall made house calls on Medicare recipients, but interestingly, the total number of home visits was increasing.³

This resurgence of interest in home health care is due in part to the increasing number of homebound patients in America, which exceeds the number of those in nursing homes.⁴ Further, a growing body of evidence indicates that home visits improve patient outcomes. And finally, many family physicians whose work lives have been centered around a busy office or hospital practice have found satisfaction in once again seeing patients in their own homes.

The COVID-19 pandemic has of course presented unique challenges—and opportunities, too—for home visits, which we discuss at the end of the article.

In the elderly, home visits have reduced functional decline, nursing home admissions, and mortality by 25% to 33%.

Why aren’t more of us making home visits?

For most of us, the decision not to make home visits is simply a matter of time and money. Although Medicare reimbursement for a home visit is typically about 150% that of a comparable office visit,⁵ it’s difficult, if not impossible, to make 2 home visits in the time you could see 3 patients in the office. So, economically it’s a net loss. Furthermore, we tend to feel less comfortable in our patients’ homes than in our offices. We have less control outside our own environment, and what happens away from our office is often less predictable—sometimes to the point that we may be concerned for our safety.

Continue to: So why make home visits at all?

So why make home visits at all?

First and foremost, home visits improve patient outcomes. This is most evident in our more vulnerable patients: newborns and the elderly, those who have been recently hospitalized, and those at risk because of their particular home situation. Multiple studies have shown that, for elders, home visits reduce functional decline, nursing home admissions, and mortality by around 25% to 33%.^6-8 For those at risk of abuse, a recent systematic review showed that home visits reduce intimate partner violence and child abuse.⁹ Another systematic review demonstrated that patients with diabetes who received home visits vs usual care were more likely to show improvements in quality of life.¹⁰ These patients were also more likely to have lower HbA1c levels and lower systolic blood pressure readings.¹⁰ A few caveats apply to these studies:

• all of them targeted “vulnerable” patients
• most studies enlisted interdisciplinary teams and had regular team meetings
• most findings reached significance only after multiple home visits.

A further reason for choosing to become involved in home care is that it builds relationships, understanding, and empathy with our patients. “There is deep symbolism in the home visit.... It says, ‘I care enough about you to leave my power base … to come and see you on your own ground.’”¹¹ And this benefit is 2-way; we also grow to understand and appreciate our patients better, especially if they are different from us culturally or socioeconomically.

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention. For the patient, home visits foster a strong sense of trust with the individual doctor and our health delivery network, and they decrease the need to seek emergency services. Finally, it has been demonstrated that provider satisfaction improves when home visits are incorporated into the work week.¹²

What is the role of community health workers in home-based care?

Community health workers (CHWs), defined as “frontline public health workers who are trusted members of and/or have an unusually close understanding of the community they serve,”¹³ can be an integral part of the home-based care team. Although CHWs have variable amounts of formal training, they have a unique perspective on local health beliefs and practices, which can assist the home-care team in providing culturally competent health care services and reduce health care costs.

In a study of children with asthma in Seattle, Washington, patients were randomized to a group that had 4 home visits by CHWs and a group that received usual care. The group that received home visits demonstrated more asthma symptom–free days, improved quality-of-life scores, and fewer urgent care visits.¹⁴ Furthermore, the intervention was estimated to save approximately $1300 per patient, resulting in a return on investment of 190%. Similarly, in a study comparing inappropriate emergency department (ED) visits between children who received CHW visits and those who did not, patients in the intervention group were significantly less likely to visit the ED for ambulatory complaints (18.2% vs 35.1%; P = .004).¹⁵

Continue to: What is the role of social workersin home-based care?

What is the role of social workersin home-based care?

Social workers can help meet the complex medical and biopsychosocial needs of the homebound population.¹⁶ A study by Cohen et al based in Israel concluded that homebound participants had a significantly higher risk for mortality, higher rates of depression, and difficulty completing instrumental activities of daily living when compared with their non-homebound counterparts.¹⁷

The Mount Sinai (New York) Visiting Doctors Program (MSVD) is a home-based care team that uses social workers to meet the needs of their complex patients.¹⁸ The social workers in the MSVD program provide direct counseling, make referrals to government and community resources, and monitor caregiver burden. Using a combination of measurement tools to assess caregiver burden, Ornstein et al demonstrated that the MSVD program led to a decrease in unmet needs and in caregiver burden.^19,20 Caregiver burnout can be assessed using the Caregiver Burden Inventory, a validated 24-item questionnaire.²¹

What electronic tools are availableto monitor patients at home?

Although expensive in terms of both dollars and personnel time, telemonitoring allows home care providers to receive real-time, updated information regarding their patients.

Chronic obstructive pulmonary disease (COPD). One systematic review showed that although telemonitoring of patients with COPD improved quality of life and decreased COPD exacerbations, it did not reduce the risk of hospitalization and, therefore, did not reduce health care costs.²² Telemonitoring in COPD can include transmission of data about spirometry parameters, weight, temperature, blood pressure, sputum color, and 6-minute walk distance.^23,24

Congestive heart failure (CHF). A 2010 Cochrane review found that telemonitoring of patients with CHF reduced all-cause mortality (risk ratio [RR] = 0.66; P < .0001).²⁵ The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial,conducted from 2013 to 2017, compared usual care for CHF patients with care incorporating daily transmission of body weight, blood pressure, heart rate, electrocardiogram tracings, pulse oximetry, and self-rated health status.²⁶ This study showed that the average number of days lost per year due to hospital admission was less in the telemonitoring group than in the usual care group (17.8 days vs. 24.2 days; P = .046). All-cause mortality was also reduced in the telemonitoring group (hazard ratio = 0.70; P = .028).

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention.

Continue to: What role do “home hospitals” play?

What role do “home hospitals” play?

Home hospitals provide acute or subacute treatment in a patient’s home for a condition that would normally require hospitalization.²⁷ In a meta-analysis of 61 studies evaluating the effectiveness of home hospitals, this option was more likely to reduce mortality (odds ratio [OR] = 0.81; P = .008) and to reduce readmission rates (OR = 0.75; P = .02).²⁸ In a study of 455 older adults, Leff et al found that hospital-at-home was associated with a shorter length of stay (3.2 vs. 4.9 days; P = .004) and that the mean cost was lower for hospital-at-home vs traditional hospital care.²⁹

However, a 2016 Cochrane review of 16 randomized controlled trials comparing hospital-at-home with traditional hospital care showed that while care in a hospital-­at-home may decrease formal costs, if costs for caregivers are taken into account, any difference in cost may disappear.³⁰

Although the evidence for cost saving is variable, hospital-at-home admission has been shown to reduce the likelihood of living in a residential care facility at 6 months (RR = 0.35; P < .0001).³⁰ Further, the same Cochrane review showed that admission avoidance may increase patient satisfaction with the care provided.³⁰

Finally, a recent randomized trial in a Boston-area hospital system showed that patients cared for in hospital-at-home were significantly less likely to be readmitted within 30 days and that adjusted cost was about two-thirds the cost of traditional hospital care.³¹

What is the physician’s rolein home health care?

While home health care is a team effort, the physician has several crucial roles. First, he or she must make the determination that home care is appropriate and feasible for a particular patient. Appropriate, meaning there is evidence that this patient is likely to benefit from home care. Feasible, meaning there are resources available in the community and family to safely care for the patient at home. “Often a house call will serve as the first step in developing a home-based-management plan.”³²

Patients with diabetes receiving home care are more likely to have improved quality of life, lower HbA1c levels, and lower systolic BP readings.

Continue to: Second, the physician serves...

Second, the physician serves an important role in directing and coordinating the team of professionals involved. This primarily means helping the team to communicate with one another. Before home visits begin, the physician’s office should reach out not only to the patient and family, but also to any other health care personnel involved in the patient’s home care. Otherwise, many of the health care providers involved will never have face-to-face interaction with the physician. Creation of the coordinated health team minimizes duplication and miscommunication; it also builds a valuable bond.

How does one go about making a home visit?

Scheduling. What often works best in a busy practice is to schedule home visits for the end of the workday or to devote an entire afternoon to making home visits to several patients in one locale. Also important is scheduling times, if possible, when important family members or other caregivers are at home or when other members of the home care team can accompany you.

What to bring along. Carry a “home visit bag” that includes equipment you’re likely to need and that is not available away from your office. A minimally equipped visit bag would include different-sized blood pressure cuffs, a glucometer, a pulse oximeter, thermometers, and patient education materials. Other suggested contents are listed in TABLE 1. Due to the COVID-19 pandemic, providers should also carry adequate personal protective equipment (PPE), including an N-95 mask.

Dos and don’ts. Take a few minutes when you first arrive to simply visit with the patient. Sit down and introduce yourself and any members of the home care team that the patient has not met. Take an interim history. While you’re doing this, be observant: Is the home neat or cluttered? Is the indoor temperature comfortable? Are there fall hazards? Is there a smell of cigarette smoke? Are there any indoor combustion sources (eg, wood stove or kerosene heater)? Ask questions such as: Who lives here with you? Can you show me where you keep your medicines? (If the patient keeps insulin or any other medicines in the refrigerator, ask to see it. Note any apparent food scarcity.)

During your exam, pay particular attention to whether vital signs are appreciably different than those measured in the office or hospital. Pay special attention to the patient’s functional abilities. “A subtle, but critical distinction between medical management in the home and medical management in the hospital, clinic, or office is the emphasis on the patient’s functional abilities, family assistance, and environmental factors.”³³

Observe the patient’s use of any home technology, if possible; this can be as simple as home oxygenation or as complex as home hemodialysis. Assess for any apparent caregiver stress. Finally, don’t neglect to offer appropriate emotional and spiritual support to the patient and family and to schedule the next follow-up visit before you leave.

Continue to:  Documentation and reimbursement.

Not all assessments will be able to be done at each visit but seeing them listed in the template can be helpful. Billing follows the same principles as for office visits and has similar requirements for documentation. Codes for the most common types of home visits are listed in TABLE 3.

Where can I get help?

Graduates of family medicine residency programs are required to receive training in home visits by the Accreditation Council for Graduate Medical Education (ACGME). Current ACGME program requirements stipulate that “residents must demonstrate competence to independently diagnose, manage, and integrate the care of patients of all ages in various outpatient settings, including the FMP [family medicine practice] site and home environment,” and “residents must be primarily responsible for a panel of continuity patients, integrating each patient’s care across all settings, including the home ...” [emphasis added].³⁴

For those already in practice, one of the hardest parts of doing home visits is feeling alone, especially if few other providers in your community engage in home care. As you run into questions and challenges with incorporating home care of patients into your practice, one excellent resource is the American Academy of Home Care Medicine (www.aahcm.org/). Founded in 1988 and headquartered in Chicago, it not only provides numerous helpful resources, but serves as a networking tool for physicians involved in home care.

Using a home visit template can help with documentation and reimbursement.

This unprecedented pandemichas allowed home visits to shine

As depicted in our opening patient case, patients who have high-risk conditions and those who are older than 65 years of age may be cared for more appropriately in a home visit rather than having them come to the office. Home visits may also be a way for providers to “lay eyes” on patients who do not have technology available to participate in virtual visits.

Before performing a home visit, inquire as to whether the patient has symptoms of COVID-19. Adequate PPE should be donned at all times and social distancing should be practiced when appropriate. With adequate PPE, home visits may also allow providers to care for low-risk patients known to have ­COVID-19 and thereby minimize risks to staff and other patients in the office. JFP

CORRESPONDENCE
Curt Elliott, MD, Prisma Health USC Family Medicine Center, 3209 Colonial Drive, Columbia, SC 29203; curtis.elliott@uscmed.sc.edu.

CASE 

Mr. A is a 30-year-old man with neurofibromatosis and myelopathy with associated quadriplegia, complicated by dysphasia and chronic hypercapnic respiratory failure requiring a tracheostomy. He is cared for at home by his very competent mother but requires regular visits with his medical providers for assistance with his complex care needs. Due to logistical challenges, he had been receiving regular home visits even before the ­COVID-19 pandemic.

After estimating the risk of exposure to the patient, Mr. A’s family and his physician’s office staff scheduled a home visit. Before the appointment, the doctor conducted a virtual visit with the patient and family members to screen for COVID-19 infection, which proved negative. The doctor arranged a visit to coincide with Mr. A’s regular appointment with the home health nurse. He invited the patient’s social worker to attend, as well.

The providers donned masks, face shields, and gloves before entering the home. Mr. A’s temperature was checked and was normal. The team completed a physical exam, assessed the patient’s current needs, and refilled prescriptions. The doctor, nurse, and social worker met afterward in the family’s driveway to coordinate plans for the patient’s future care.

This encounter allowed a vulnerable patient with special needs to have access to care while reducing his risk of undesirable exposure. Also, his health care team’s provision of care in the home setting reduced Mr. A’s anxiety and that of his family members.

Home visits have long been an integral part of what it means to be a family physician. In 1930, roughly 40% of all patient-physician encounters in the United States occurred in patients’ homes. By 1980, this number had dropped to < 1%.¹ Still, a 1994 survey of American doctors in 3 primary care specialties revealed that 63% of family physicians, more than the other 2 specialties, still made house calls.² A 2016 analysis of Medicare claims data showed that between 2006 and 2011, only 5% of American doctors overall made house calls on Medicare recipients, but interestingly, the total number of home visits was increasing.³

This resurgence of interest in home health care is due in part to the increasing number of homebound patients in America, which exceeds the number of those in nursing homes.⁴ Further, a growing body of evidence indicates that home visits improve patient outcomes. And finally, many family physicians whose work lives have been centered around a busy office or hospital practice have found satisfaction in once again seeing patients in their own homes.

The COVID-19 pandemic has of course presented unique challenges—and opportunities, too—for home visits, which we discuss at the end of the article.

In the elderly, home visits have reduced functional decline, nursing home admissions, and mortality by 25% to 33%.

Why aren’t more of us making home visits?

For most of us, the decision not to make home visits is simply a matter of time and money. Although Medicare reimbursement for a home visit is typically about 150% that of a comparable office visit,⁵ it’s difficult, if not impossible, to make 2 home visits in the time you could see 3 patients in the office. So, economically it’s a net loss. Furthermore, we tend to feel less comfortable in our patients’ homes than in our offices. We have less control outside our own environment, and what happens away from our office is often less predictable—sometimes to the point that we may be concerned for our safety.

Continue to: So why make home visits at all?

So why make home visits at all?

First and foremost, home visits improve patient outcomes. This is most evident in our more vulnerable patients: newborns and the elderly, those who have been recently hospitalized, and those at risk because of their particular home situation. Multiple studies have shown that, for elders, home visits reduce functional decline, nursing home admissions, and mortality by around 25% to 33%.^6-8 For those at risk of abuse, a recent systematic review showed that home visits reduce intimate partner violence and child abuse.⁹ Another systematic review demonstrated that patients with diabetes who received home visits vs usual care were more likely to show improvements in quality of life.¹⁰ These patients were also more likely to have lower HbA1c levels and lower systolic blood pressure readings.¹⁰ A few caveats apply to these studies:

• all of them targeted “vulnerable” patients
• most studies enlisted interdisciplinary teams and had regular team meetings
• most findings reached significance only after multiple home visits.

A further reason for choosing to become involved in home care is that it builds relationships, understanding, and empathy with our patients. “There is deep symbolism in the home visit.... It says, ‘I care enough about you to leave my power base … to come and see you on your own ground.’”¹¹ And this benefit is 2-way; we also grow to understand and appreciate our patients better, especially if they are different from us culturally or socioeconomically.

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention. For the patient, home visits foster a strong sense of trust with the individual doctor and our health delivery network, and they decrease the need to seek emergency services. Finally, it has been demonstrated that provider satisfaction improves when home visits are incorporated into the work week.¹²

What is the role of community health workers in home-based care?

Community health workers (CHWs), defined as “frontline public health workers who are trusted members of and/or have an unusually close understanding of the community they serve,”¹³ can be an integral part of the home-based care team. Although CHWs have variable amounts of formal training, they have a unique perspective on local health beliefs and practices, which can assist the home-care team in providing culturally competent health care services and reduce health care costs.

In a study of children with asthma in Seattle, Washington, patients were randomized to a group that had 4 home visits by CHWs and a group that received usual care. The group that received home visits demonstrated more asthma symptom–free days, improved quality-of-life scores, and fewer urgent care visits.¹⁴ Furthermore, the intervention was estimated to save approximately $1300 per patient, resulting in a return on investment of 190%. Similarly, in a study comparing inappropriate emergency department (ED) visits between children who received CHW visits and those who did not, patients in the intervention group were significantly less likely to visit the ED for ambulatory complaints (18.2% vs 35.1%; P = .004).¹⁵

Continue to: What is the role of social workersin home-based care?

What is the role of social workersin home-based care?

Social workers can help meet the complex medical and biopsychosocial needs of the homebound population.¹⁶ A study by Cohen et al based in Israel concluded that homebound participants had a significantly higher risk for mortality, higher rates of depression, and difficulty completing instrumental activities of daily living when compared with their non-homebound counterparts.¹⁷

The Mount Sinai (New York) Visiting Doctors Program (MSVD) is a home-based care team that uses social workers to meet the needs of their complex patients.¹⁸ The social workers in the MSVD program provide direct counseling, make referrals to government and community resources, and monitor caregiver burden. Using a combination of measurement tools to assess caregiver burden, Ornstein et al demonstrated that the MSVD program led to a decrease in unmet needs and in caregiver burden.^19,20 Caregiver burnout can be assessed using the Caregiver Burden Inventory, a validated 24-item questionnaire.²¹

What electronic tools are availableto monitor patients at home?

Although expensive in terms of both dollars and personnel time, telemonitoring allows home care providers to receive real-time, updated information regarding their patients.

Chronic obstructive pulmonary disease (COPD). One systematic review showed that although telemonitoring of patients with COPD improved quality of life and decreased COPD exacerbations, it did not reduce the risk of hospitalization and, therefore, did not reduce health care costs.²² Telemonitoring in COPD can include transmission of data about spirometry parameters, weight, temperature, blood pressure, sputum color, and 6-minute walk distance.^23,24

Congestive heart failure (CHF). A 2010 Cochrane review found that telemonitoring of patients with CHF reduced all-cause mortality (risk ratio [RR] = 0.66; P < .0001).²⁵ The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial,conducted from 2013 to 2017, compared usual care for CHF patients with care incorporating daily transmission of body weight, blood pressure, heart rate, electrocardiogram tracings, pulse oximetry, and self-rated health status.²⁶ This study showed that the average number of days lost per year due to hospital admission was less in the telemonitoring group than in the usual care group (17.8 days vs. 24.2 days; P = .046). All-cause mortality was also reduced in the telemonitoring group (hazard ratio = 0.70; P = .028).

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention.

Continue to: What role do “home hospitals” play?

What role do “home hospitals” play?

Home hospitals provide acute or subacute treatment in a patient’s home for a condition that would normally require hospitalization.²⁷ In a meta-analysis of 61 studies evaluating the effectiveness of home hospitals, this option was more likely to reduce mortality (odds ratio [OR] = 0.81; P = .008) and to reduce readmission rates (OR = 0.75; P = .02).²⁸ In a study of 455 older adults, Leff et al found that hospital-at-home was associated with a shorter length of stay (3.2 vs. 4.9 days; P = .004) and that the mean cost was lower for hospital-at-home vs traditional hospital care.²⁹

However, a 2016 Cochrane review of 16 randomized controlled trials comparing hospital-at-home with traditional hospital care showed that while care in a hospital-­at-home may decrease formal costs, if costs for caregivers are taken into account, any difference in cost may disappear.³⁰

Although the evidence for cost saving is variable, hospital-at-home admission has been shown to reduce the likelihood of living in a residential care facility at 6 months (RR = 0.35; P < .0001).³⁰ Further, the same Cochrane review showed that admission avoidance may increase patient satisfaction with the care provided.³⁰

Finally, a recent randomized trial in a Boston-area hospital system showed that patients cared for in hospital-at-home were significantly less likely to be readmitted within 30 days and that adjusted cost was about two-thirds the cost of traditional hospital care.³¹

What is the physician’s rolein home health care?

While home health care is a team effort, the physician has several crucial roles. First, he or she must make the determination that home care is appropriate and feasible for a particular patient. Appropriate, meaning there is evidence that this patient is likely to benefit from home care. Feasible, meaning there are resources available in the community and family to safely care for the patient at home. “Often a house call will serve as the first step in developing a home-based-management plan.”³²

Patients with diabetes receiving home care are more likely to have improved quality of life, lower HbA1c levels, and lower systolic BP readings.

Continue to: Second, the physician serves...

Second, the physician serves an important role in directing and coordinating the team of professionals involved. This primarily means helping the team to communicate with one another. Before home visits begin, the physician’s office should reach out not only to the patient and family, but also to any other health care personnel involved in the patient’s home care. Otherwise, many of the health care providers involved will never have face-to-face interaction with the physician. Creation of the coordinated health team minimizes duplication and miscommunication; it also builds a valuable bond.

How does one go about making a home visit?

Scheduling. What often works best in a busy practice is to schedule home visits for the end of the workday or to devote an entire afternoon to making home visits to several patients in one locale. Also important is scheduling times, if possible, when important family members or other caregivers are at home or when other members of the home care team can accompany you.

What to bring along. Carry a “home visit bag” that includes equipment you’re likely to need and that is not available away from your office. A minimally equipped visit bag would include different-sized blood pressure cuffs, a glucometer, a pulse oximeter, thermometers, and patient education materials. Other suggested contents are listed in TABLE 1. Due to the COVID-19 pandemic, providers should also carry adequate personal protective equipment (PPE), including an N-95 mask.

Dos and don’ts. Take a few minutes when you first arrive to simply visit with the patient. Sit down and introduce yourself and any members of the home care team that the patient has not met. Take an interim history. While you’re doing this, be observant: Is the home neat or cluttered? Is the indoor temperature comfortable? Are there fall hazards? Is there a smell of cigarette smoke? Are there any indoor combustion sources (eg, wood stove or kerosene heater)? Ask questions such as: Who lives here with you? Can you show me where you keep your medicines? (If the patient keeps insulin or any other medicines in the refrigerator, ask to see it. Note any apparent food scarcity.)

During your exam, pay particular attention to whether vital signs are appreciably different than those measured in the office or hospital. Pay special attention to the patient’s functional abilities. “A subtle, but critical distinction between medical management in the home and medical management in the hospital, clinic, or office is the emphasis on the patient’s functional abilities, family assistance, and environmental factors.”³³

Observe the patient’s use of any home technology, if possible; this can be as simple as home oxygenation or as complex as home hemodialysis. Assess for any apparent caregiver stress. Finally, don’t neglect to offer appropriate emotional and spiritual support to the patient and family and to schedule the next follow-up visit before you leave.

Continue to:  Documentation and reimbursement.

Not all assessments will be able to be done at each visit but seeing them listed in the template can be helpful. Billing follows the same principles as for office visits and has similar requirements for documentation. Codes for the most common types of home visits are listed in TABLE 3.

Where can I get help?

Graduates of family medicine residency programs are required to receive training in home visits by the Accreditation Council for Graduate Medical Education (ACGME). Current ACGME program requirements stipulate that “residents must demonstrate competence to independently diagnose, manage, and integrate the care of patients of all ages in various outpatient settings, including the FMP [family medicine practice] site and home environment,” and “residents must be primarily responsible for a panel of continuity patients, integrating each patient’s care across all settings, including the home ...” [emphasis added].³⁴

For those already in practice, one of the hardest parts of doing home visits is feeling alone, especially if few other providers in your community engage in home care. As you run into questions and challenges with incorporating home care of patients into your practice, one excellent resource is the American Academy of Home Care Medicine (www.aahcm.org/). Founded in 1988 and headquartered in Chicago, it not only provides numerous helpful resources, but serves as a networking tool for physicians involved in home care.

Using a home visit template can help with documentation and reimbursement.

This unprecedented pandemichas allowed home visits to shine

As depicted in our opening patient case, patients who have high-risk conditions and those who are older than 65 years of age may be cared for more appropriately in a home visit rather than having them come to the office. Home visits may also be a way for providers to “lay eyes” on patients who do not have technology available to participate in virtual visits.

Before performing a home visit, inquire as to whether the patient has symptoms of COVID-19. Adequate PPE should be donned at all times and social distancing should be practiced when appropriate. With adequate PPE, home visits may also allow providers to care for low-risk patients known to have ­COVID-19 and thereby minimize risks to staff and other patients in the office. JFP

CORRESPONDENCE
Curt Elliott, MD, Prisma Health USC Family Medicine Center, 3209 Colonial Drive, Columbia, SC 29203; curtis.elliott@uscmed.sc.edu.

CASE 

Mr. A is a 30-year-old man with neurofibromatosis and myelopathy with associated quadriplegia, complicated by dysphasia and chronic hypercapnic respiratory failure requiring a tracheostomy. He is cared for at home by his very competent mother but requires regular visits with his medical providers for assistance with his complex care needs. Due to logistical challenges, he had been receiving regular home visits even before the ­COVID-19 pandemic.

After estimating the risk of exposure to the patient, Mr. A’s family and his physician’s office staff scheduled a home visit. Before the appointment, the doctor conducted a virtual visit with the patient and family members to screen for COVID-19 infection, which proved negative. The doctor arranged a visit to coincide with Mr. A’s regular appointment with the home health nurse. He invited the patient’s social worker to attend, as well.

The providers donned masks, face shields, and gloves before entering the home. Mr. A’s temperature was checked and was normal. The team completed a physical exam, assessed the patient’s current needs, and refilled prescriptions. The doctor, nurse, and social worker met afterward in the family’s driveway to coordinate plans for the patient’s future care.

This encounter allowed a vulnerable patient with special needs to have access to care while reducing his risk of undesirable exposure. Also, his health care team’s provision of care in the home setting reduced Mr. A’s anxiety and that of his family members.

Home visits have long been an integral part of what it means to be a family physician. In 1930, roughly 40% of all patient-physician encounters in the United States occurred in patients’ homes. By 1980, this number had dropped to < 1%.¹ Still, a 1994 survey of American doctors in 3 primary care specialties revealed that 63% of family physicians, more than the other 2 specialties, still made house calls.² A 2016 analysis of Medicare claims data showed that between 2006 and 2011, only 5% of American doctors overall made house calls on Medicare recipients, but interestingly, the total number of home visits was increasing.³

This resurgence of interest in home health care is due in part to the increasing number of homebound patients in America, which exceeds the number of those in nursing homes.⁴ Further, a growing body of evidence indicates that home visits improve patient outcomes. And finally, many family physicians whose work lives have been centered around a busy office or hospital practice have found satisfaction in once again seeing patients in their own homes.

The COVID-19 pandemic has of course presented unique challenges—and opportunities, too—for home visits, which we discuss at the end of the article.

In the elderly, home visits have reduced functional decline, nursing home admissions, and mortality by 25% to 33%.

Why aren’t more of us making home visits?

For most of us, the decision not to make home visits is simply a matter of time and money. Although Medicare reimbursement for a home visit is typically about 150% that of a comparable office visit,⁵ it’s difficult, if not impossible, to make 2 home visits in the time you could see 3 patients in the office. So, economically it’s a net loss. Furthermore, we tend to feel less comfortable in our patients’ homes than in our offices. We have less control outside our own environment, and what happens away from our office is often less predictable—sometimes to the point that we may be concerned for our safety.

Continue to: So why make home visits at all?

So why make home visits at all?

First and foremost, home visits improve patient outcomes. This is most evident in our more vulnerable patients: newborns and the elderly, those who have been recently hospitalized, and those at risk because of their particular home situation. Multiple studies have shown that, for elders, home visits reduce functional decline, nursing home admissions, and mortality by around 25% to 33%.^6-8 For those at risk of abuse, a recent systematic review showed that home visits reduce intimate partner violence and child abuse.⁹ Another systematic review demonstrated that patients with diabetes who received home visits vs usual care were more likely to show improvements in quality of life.¹⁰ These patients were also more likely to have lower HbA1c levels and lower systolic blood pressure readings.¹⁰ A few caveats apply to these studies:

• all of them targeted “vulnerable” patients
• most studies enlisted interdisciplinary teams and had regular team meetings
• most findings reached significance only after multiple home visits.

A further reason for choosing to become involved in home care is that it builds relationships, understanding, and empathy with our patients. “There is deep symbolism in the home visit.... It says, ‘I care enough about you to leave my power base … to come and see you on your own ground.’”¹¹ And this benefit is 2-way; we also grow to understand and appreciate our patients better, especially if they are different from us culturally or socioeconomically.

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention. For the patient, home visits foster a strong sense of trust with the individual doctor and our health delivery network, and they decrease the need to seek emergency services. Finally, it has been demonstrated that provider satisfaction improves when home visits are incorporated into the work week.¹²

What is the role of community health workers in home-based care?

Community health workers (CHWs), defined as “frontline public health workers who are trusted members of and/or have an unusually close understanding of the community they serve,”¹³ can be an integral part of the home-based care team. Although CHWs have variable amounts of formal training, they have a unique perspective on local health beliefs and practices, which can assist the home-care team in providing culturally competent health care services and reduce health care costs.

In a study of children with asthma in Seattle, Washington, patients were randomized to a group that had 4 home visits by CHWs and a group that received usual care. The group that received home visits demonstrated more asthma symptom–free days, improved quality-of-life scores, and fewer urgent care visits.¹⁴ Furthermore, the intervention was estimated to save approximately $1300 per patient, resulting in a return on investment of 190%. Similarly, in a study comparing inappropriate emergency department (ED) visits between children who received CHW visits and those who did not, patients in the intervention group were significantly less likely to visit the ED for ambulatory complaints (18.2% vs 35.1%; P = .004).¹⁵

Continue to: What is the role of social workersin home-based care?

What is the role of social workersin home-based care?

Social workers can help meet the complex medical and biopsychosocial needs of the homebound population.¹⁶ A study by Cohen et al based in Israel concluded that homebound participants had a significantly higher risk for mortality, higher rates of depression, and difficulty completing instrumental activities of daily living when compared with their non-homebound counterparts.¹⁷

The Mount Sinai (New York) Visiting Doctors Program (MSVD) is a home-based care team that uses social workers to meet the needs of their complex patients.¹⁸ The social workers in the MSVD program provide direct counseling, make referrals to government and community resources, and monitor caregiver burden. Using a combination of measurement tools to assess caregiver burden, Ornstein et al demonstrated that the MSVD program led to a decrease in unmet needs and in caregiver burden.^19,20 Caregiver burnout can be assessed using the Caregiver Burden Inventory, a validated 24-item questionnaire.²¹

What electronic tools are availableto monitor patients at home?

Although expensive in terms of both dollars and personnel time, telemonitoring allows home care providers to receive real-time, updated information regarding their patients.

Chronic obstructive pulmonary disease (COPD). One systematic review showed that although telemonitoring of patients with COPD improved quality of life and decreased COPD exacerbations, it did not reduce the risk of hospitalization and, therefore, did not reduce health care costs.²² Telemonitoring in COPD can include transmission of data about spirometry parameters, weight, temperature, blood pressure, sputum color, and 6-minute walk distance.^23,24

Congestive heart failure (CHF). A 2010 Cochrane review found that telemonitoring of patients with CHF reduced all-cause mortality (risk ratio [RR] = 0.66; P < .0001).²⁵ The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial,conducted from 2013 to 2017, compared usual care for CHF patients with care incorporating daily transmission of body weight, blood pressure, heart rate, electrocardiogram tracings, pulse oximetry, and self-rated health status.²⁶ This study showed that the average number of days lost per year due to hospital admission was less in the telemonitoring group than in the usual care group (17.8 days vs. 24.2 days; P = .046). All-cause mortality was also reduced in the telemonitoring group (hazard ratio = 0.70; P = .028).

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention.

Continue to: What role do “home hospitals” play?

What role do “home hospitals” play?

Home hospitals provide acute or subacute treatment in a patient’s home for a condition that would normally require hospitalization.²⁷ In a meta-analysis of 61 studies evaluating the effectiveness of home hospitals, this option was more likely to reduce mortality (odds ratio [OR] = 0.81; P = .008) and to reduce readmission rates (OR = 0.75; P = .02).²⁸ In a study of 455 older adults, Leff et al found that hospital-at-home was associated with a shorter length of stay (3.2 vs. 4.9 days; P = .004) and that the mean cost was lower for hospital-at-home vs traditional hospital care.²⁹

However, a 2016 Cochrane review of 16 randomized controlled trials comparing hospital-at-home with traditional hospital care showed that while care in a hospital-­at-home may decrease formal costs, if costs for caregivers are taken into account, any difference in cost may disappear.³⁰

Although the evidence for cost saving is variable, hospital-at-home admission has been shown to reduce the likelihood of living in a residential care facility at 6 months (RR = 0.35; P < .0001).³⁰ Further, the same Cochrane review showed that admission avoidance may increase patient satisfaction with the care provided.³⁰

Finally, a recent randomized trial in a Boston-area hospital system showed that patients cared for in hospital-at-home were significantly less likely to be readmitted within 30 days and that adjusted cost was about two-thirds the cost of traditional hospital care.³¹

What is the physician’s rolein home health care?

While home health care is a team effort, the physician has several crucial roles. First, he or she must make the determination that home care is appropriate and feasible for a particular patient. Appropriate, meaning there is evidence that this patient is likely to benefit from home care. Feasible, meaning there are resources available in the community and family to safely care for the patient at home. “Often a house call will serve as the first step in developing a home-based-management plan.”³²

Patients with diabetes receiving home care are more likely to have improved quality of life, lower HbA1c levels, and lower systolic BP readings.

Continue to: Second, the physician serves...

Second, the physician serves an important role in directing and coordinating the team of professionals involved. This primarily means helping the team to communicate with one another. Before home visits begin, the physician’s office should reach out not only to the patient and family, but also to any other health care personnel involved in the patient’s home care. Otherwise, many of the health care providers involved will never have face-to-face interaction with the physician. Creation of the coordinated health team minimizes duplication and miscommunication; it also builds a valuable bond.

How does one go about making a home visit?

Scheduling. What often works best in a busy practice is to schedule home visits for the end of the workday or to devote an entire afternoon to making home visits to several patients in one locale. Also important is scheduling times, if possible, when important family members or other caregivers are at home or when other members of the home care team can accompany you.

What to bring along. Carry a “home visit bag” that includes equipment you’re likely to need and that is not available away from your office. A minimally equipped visit bag would include different-sized blood pressure cuffs, a glucometer, a pulse oximeter, thermometers, and patient education materials. Other suggested contents are listed in TABLE 1. Due to the COVID-19 pandemic, providers should also carry adequate personal protective equipment (PPE), including an N-95 mask.

Dos and don’ts. Take a few minutes when you first arrive to simply visit with the patient. Sit down and introduce yourself and any members of the home care team that the patient has not met. Take an interim history. While you’re doing this, be observant: Is the home neat or cluttered? Is the indoor temperature comfortable? Are there fall hazards? Is there a smell of cigarette smoke? Are there any indoor combustion sources (eg, wood stove or kerosene heater)? Ask questions such as: Who lives here with you? Can you show me where you keep your medicines? (If the patient keeps insulin or any other medicines in the refrigerator, ask to see it. Note any apparent food scarcity.)

During your exam, pay particular attention to whether vital signs are appreciably different than those measured in the office or hospital. Pay special attention to the patient’s functional abilities. “A subtle, but critical distinction between medical management in the home and medical management in the hospital, clinic, or office is the emphasis on the patient’s functional abilities, family assistance, and environmental factors.”³³

Observe the patient’s use of any home technology, if possible; this can be as simple as home oxygenation or as complex as home hemodialysis. Assess for any apparent caregiver stress. Finally, don’t neglect to offer appropriate emotional and spiritual support to the patient and family and to schedule the next follow-up visit before you leave.

Continue to:  Documentation and reimbursement.

Not all assessments will be able to be done at each visit but seeing them listed in the template can be helpful. Billing follows the same principles as for office visits and has similar requirements for documentation. Codes for the most common types of home visits are listed in TABLE 3.

Where can I get help?

Graduates of family medicine residency programs are required to receive training in home visits by the Accreditation Council for Graduate Medical Education (ACGME). Current ACGME program requirements stipulate that “residents must demonstrate competence to independently diagnose, manage, and integrate the care of patients of all ages in various outpatient settings, including the FMP [family medicine practice] site and home environment,” and “residents must be primarily responsible for a panel of continuity patients, integrating each patient’s care across all settings, including the home ...” [emphasis added].³⁴

For those already in practice, one of the hardest parts of doing home visits is feeling alone, especially if few other providers in your community engage in home care. As you run into questions and challenges with incorporating home care of patients into your practice, one excellent resource is the American Academy of Home Care Medicine (www.aahcm.org/). Founded in 1988 and headquartered in Chicago, it not only provides numerous helpful resources, but serves as a networking tool for physicians involved in home care.

Using a home visit template can help with documentation and reimbursement.

This unprecedented pandemichas allowed home visits to shine

As depicted in our opening patient case, patients who have high-risk conditions and those who are older than 65 years of age may be cared for more appropriately in a home visit rather than having them come to the office. Home visits may also be a way for providers to “lay eyes” on patients who do not have technology available to participate in virtual visits.

Before performing a home visit, inquire as to whether the patient has symptoms of COVID-19. Adequate PPE should be donned at all times and social distancing should be practiced when appropriate. With adequate PPE, home visits may also allow providers to care for low-risk patients known to have ­COVID-19 and thereby minimize risks to staff and other patients in the office. JFP

CORRESPONDENCE
Curt Elliott, MD, Prisma Health USC Family Medicine Center, 3209 Colonial Drive, Columbia, SC 29203; curtis.elliott@uscmed.sc.edu.

In this issue of The Journal of Family Practice, Dr. Wayne Jonas explains his model for Advanced Primary Care (see page 493). The figure he uses to illustrate Advanced Primary Care is compelling, and the effectiveness of this model of health care is supported by a great deal of research and evaluation over the past 20 years. Let me provide some historical context.

The idea that healing requires more than curative, biology-based medical care dates back to Greek mythology. Asclepius, the god of medicine, had 5 daughters, Hygeia (the goddess of good health and hygiene), Iaso (cures and remedies), Aceso (healing wounds), Aegle (radiant good health), and Panacea (cures).¹ Clearly, the Greeks believed that integrative care is essential for maintaining good health!

Modern, scientific medicine is a relatively recent development in human history. Other traditions of healing such as acupuncture and herbal medicines are actually much older than mainstream Western medicine. But they come together in family medicine—a specialty founded on the principles of whole person, whole family, and whole community care.

We can no longer go “halfway” into whole-person care.

The first modern model of comprehensive care, the patient-centered medical home (PCMH), was introduced by the American Academy of Pediatrics in 1967. This idea caught on widely and was institutionalized by the National Committee for Quality Assurance in 2008 with PCMH certification.

Advanced Primary Care is the latest and best rendition of comprehensive primary health care. Funding this model through our current payment mechanisms, however, has been difficult because of the need to support social and behavioral interventions in addition to medical care—areas of care not traditionally paid for by medical premiums. In 2011, CMS collaborated with private insurers in a national demonstration project to test the financial feasibility of implementing Advanced Primary Care. Some organizations have been highly successful; others not as much.

We can no longer go “halfway” into whole-person care. The COVID-19 pandemic has put a spotlight on our need to transform payment models away from fee-for-service to reimbursement for whole person primary care. Our nation’s health and the viability of our health care system depend on it. 

PS: I recommend reading Dr. Jonas’ book, How Healing Works, which provides a scientific rationale for the application of whole-person care to healing.
 

In this issue of The Journal of Family Practice, Dr. Wayne Jonas explains his model for Advanced Primary Care (see page 493). The figure he uses to illustrate Advanced Primary Care is compelling, and the effectiveness of this model of health care is supported by a great deal of research and evaluation over the past 20 years. Let me provide some historical context.

The idea that healing requires more than curative, biology-based medical care dates back to Greek mythology. Asclepius, the god of medicine, had 5 daughters, Hygeia (the goddess of good health and hygiene), Iaso (cures and remedies), Aceso (healing wounds), Aegle (radiant good health), and Panacea (cures).¹ Clearly, the Greeks believed that integrative care is essential for maintaining good health!

Modern, scientific medicine is a relatively recent development in human history. Other traditions of healing such as acupuncture and herbal medicines are actually much older than mainstream Western medicine. But they come together in family medicine—a specialty founded on the principles of whole person, whole family, and whole community care.

We can no longer go “halfway” into whole-person care.

The first modern model of comprehensive care, the patient-centered medical home (PCMH), was introduced by the American Academy of Pediatrics in 1967. This idea caught on widely and was institutionalized by the National Committee for Quality Assurance in 2008 with PCMH certification.

Advanced Primary Care is the latest and best rendition of comprehensive primary health care. Funding this model through our current payment mechanisms, however, has been difficult because of the need to support social and behavioral interventions in addition to medical care—areas of care not traditionally paid for by medical premiums. In 2011, CMS collaborated with private insurers in a national demonstration project to test the financial feasibility of implementing Advanced Primary Care. Some organizations have been highly successful; others not as much.

We can no longer go “halfway” into whole-person care. The COVID-19 pandemic has put a spotlight on our need to transform payment models away from fee-for-service to reimbursement for whole person primary care. Our nation’s health and the viability of our health care system depend on it. 

PS: I recommend reading Dr. Jonas’ book, How Healing Works, which provides a scientific rationale for the application of whole-person care to healing.
 

In this issue of The Journal of Family Practice, Dr. Wayne Jonas explains his model for Advanced Primary Care (see page 493). The figure he uses to illustrate Advanced Primary Care is compelling, and the effectiveness of this model of health care is supported by a great deal of research and evaluation over the past 20 years. Let me provide some historical context.

The idea that healing requires more than curative, biology-based medical care dates back to Greek mythology. Asclepius, the god of medicine, had 5 daughters, Hygeia (the goddess of good health and hygiene), Iaso (cures and remedies), Aceso (healing wounds), Aegle (radiant good health), and Panacea (cures).¹ Clearly, the Greeks believed that integrative care is essential for maintaining good health!

Modern, scientific medicine is a relatively recent development in human history. Other traditions of healing such as acupuncture and herbal medicines are actually much older than mainstream Western medicine. But they come together in family medicine—a specialty founded on the principles of whole person, whole family, and whole community care.

We can no longer go “halfway” into whole-person care.

The first modern model of comprehensive care, the patient-centered medical home (PCMH), was introduced by the American Academy of Pediatrics in 1967. This idea caught on widely and was institutionalized by the National Committee for Quality Assurance in 2008 with PCMH certification.

Advanced Primary Care is the latest and best rendition of comprehensive primary health care. Funding this model through our current payment mechanisms, however, has been difficult because of the need to support social and behavioral interventions in addition to medical care—areas of care not traditionally paid for by medical premiums. In 2011, CMS collaborated with private insurers in a national demonstration project to test the financial feasibility of implementing Advanced Primary Care. Some organizations have been highly successful; others not as much.

We can no longer go “halfway” into whole-person care. The COVID-19 pandemic has put a spotlight on our need to transform payment models away from fee-for-service to reimbursement for whole person primary care. Our nation’s health and the viability of our health care system depend on it. 

PS: I recommend reading Dr. Jonas’ book, How Healing Works, which provides a scientific rationale for the application of whole-person care to healing.
 

THE CASE

A 17-year-old White girl with no known past medical history presented to the emergency department (ED) with complaints of abdominal pain and pruritus. The abdominal pain had started 9 days prior and lasted for 3 days. One day after resolution, she developed bilateral lower extremity itching, which was not relieved with loratadine.

Review of systems included dark urine and yellow eyes noted for several days. The patient denied nausea, vomiting, diarrhea, constipation, fevers, chills, arthralgias, recent illness, travel, or sick contacts. Immunizations were up to date. The patient had no history of surgery or liver disease and no pertinent family history. Her current medications included ethinyl estradiol/norethindrone acetate for birth control and minocycline for acne vulgaris. She had been taking the latter medication for 2 years. No additional medications were noted, including vitamins, over-the-counter medications, or supplements. She denied smoking and alcohol or recreational drug use.

In the ED, the patient had normal vital signs. Physical exam findings included bilateral scleral icterus and scattered skin excoriations on the hands, arms, back of the neck, and feet. At the time of hospital admission, the patient’s minocycline and birth control were held under the initial presumption that one or both might be contributing to her presentation.

Pertinent laboratory findings included aspartate transaminase (AST), 828 U/L (normal range, 2-40 U/L); alanine aminotransferase (ALT), 784 U/L (normal range, 3-30 U/L); lactic acid dehydrogenase, 520 U/L (normal range, 140-280 U/L); alkaline phosphatase, 119 U/L (normal range, 44-147 U/L); total bilirubin, 1.9 µmol/L (normal range, 2-18 µmol/L); and direct bilirubin, 1.3 µmol/L (normal range, 0-4 µmol/L). Baseline liver function test results (prior to admission) were unknown. Results of a coagulation panel, complete blood count, basic metabolic panel, amylase, lipase, urine toxicology, and urinalysis all were within normal limits.

Ultrasound of the abdomen revealed a normal abdomen, liver, pancreas, gallbladder, and common bile duct. This imaging study was negative for other obstructive pathologies.

THE DIAGNOSIS

During hospital admission, a noninvasive liver work-up was pursued by Gastroenterology. A hepatitis panel, Epstein-Barr virus testing, and levels of ceruloplasmin and acetaminophen were all found to be within normal limits, excluding additional causes of liver disease. Serum antinuclear antibody (ANA) testing was significantly positive, with a titer of 1:640 (range, < 1:20) and, as noted above, liver transaminases were severely elevated, leading to a presumptive diagnosis of drug-induced liver pathology.

Continue to: During outpatient follow-up...

During outpatient follow-up with Gastroenterology 2 days after discharge, the patient’s liver transaminases and bilirubin continued to trend upward (to a maximum ALT of 871 U/L; AST, 1097 U/L; alkaline phosphatase, 122 U/L; and bilirubin, 2.9 µmol/L). Immunoglobulin G was 1342 mg/mL (normal range, 694-1618 mg/mL).

An ultrasound-guided liver biopsy was performed; it demonstrated lobular, portal, and periportal hepatitis with focal bridging necrosis, consistent with a diagnosis of autoimmune hepatitis. Mild-to-moderate focal cholestasis was demonstrated, consistent with cholestatic hepatitis.

DISCUSSION

Autoimmune hepatitis is characterized by inflammation of the liver, secondary to the presence of circulating antibodies or hypergammaglobulinemia. The pathogenesis is thought to involve a T-cell–mediated immune attack on the liver. Based on case reports,the use of minocycline is associated with risk for liver injury, although the incidence is rare.^1-4 Use of this medication may be associated with autoimmune disease in patients who are predisposed to autoimmune tendencies or who have genetic predeterminants.

Diagnosis is typically made based on abnormalities in aminotransferases (AST, ALT), elevation in serum immunoglobulins, and positive auto-antibody titers including ANA, smooth muscle antibodies, and anti-liver kidney microsomal type 1 antibodies. Although clinical presentations tend to differ, the confirmatory diagnosis is typically made histologically, with the presence of lobular and perivenular necro-inflammatory changes and plasma cell infiltration.⁵

Other infectious and metabolic causes of hepatitis should be excluded. Many medications and herbal agents have been noted to cause autoimmune hepatitis or similar syndromes that mimic the condition.

Medication history. Review of the case patient’s medication list identified ethinyl estradiol/norethindrone acetate and minocycline as potential culprits. Ethinyl estradiol/norethindrone acetate is a low-dose combination oral contraceptive pill (OCP). Although earlier formulations of OCPs were associated with hepatobiliary complications, these adverse effects are noted to be rare in the absence of predisposing conditions.⁶ In some cases, OCPs have been linked to cholestasis, chronic hepatocellular carcinoma, or hepatic adenomas, but studies have shown that these medications do not affect the course of acute liver failure.⁷

Continue to: Minocycline...

Minocyclineassociated hepatotoxicity can be due to a systemic hypersensitivity reaction, occurring within a few weeks of therapy initiation, whereas autoimmune hepatitis manifests after a year or more of exposure to the medication.

In this case, given the patient’s 2-year history of minocycline use, it is possible that she developed an acute presentation of autoimmune hepatitis. With drug-induced autoimmune liver injury, complete resolution occurs after withdrawal of the offending medication, and a response to corticosteroid therapy supports the diagnosis. Recurrence of signs or symptoms following corticosteroid cessation may indicate idiopathic autoimmune hepatitis as opposed to a drug-induced form.²

Our patient was started on steroid and immunomodulator therapy, with prednisone 40 mg/d and mycophenolate 250 mg bid. At follow-up with Gastroenterology, the patient’s symptoms and liver function test results had improved significantly (AST, 27 U/L; ALT, 14 U/L; alkaline phosphatase, 51 U/L; and total bilirubin, 0.4 µmol/L). The patient was continued on a prednisone taper while simultaneously titrating mycophenolate. The ultimate plan of care included continuing mycophenolate for a total of 4 to 5 years.

THE TAKEAWAY

During evaluation of a patient with new-onset liver disease, it is important to inquire about prescription medications, drugs, vitamins, and herbal supplements as possible contributors to the disease process. This case highlights the importance of monitoring patients while on minocycline and of weighing the risks vs benefits of long-term therapy. It has been suggested that liver enzymes be tested before therapy initiation and about every 3 months during long-term antibiotic treatment.⁴ Careful consideration and caution should be taken prior to the initiation of medications that have been linked to rare, but important, adverse reactions.

ACKNOWLEDGEMENT

The authors would like to thank Frank Bauer, MD, and Eva Sotil, MD, for their contributions to this case presentation.

CORRESPONDENCE

Andrea Gillis, DO, Asylum Hill Family Medicine Center, 99 Woodland Street, Hartford, CT 06105; andrea.gillis@ trinityhealthofne.org

THE CASE

A 17-year-old White girl with no known past medical history presented to the emergency department (ED) with complaints of abdominal pain and pruritus. The abdominal pain had started 9 days prior and lasted for 3 days. One day after resolution, she developed bilateral lower extremity itching, which was not relieved with loratadine.

Review of systems included dark urine and yellow eyes noted for several days. The patient denied nausea, vomiting, diarrhea, constipation, fevers, chills, arthralgias, recent illness, travel, or sick contacts. Immunizations were up to date. The patient had no history of surgery or liver disease and no pertinent family history. Her current medications included ethinyl estradiol/norethindrone acetate for birth control and minocycline for acne vulgaris. She had been taking the latter medication for 2 years. No additional medications were noted, including vitamins, over-the-counter medications, or supplements. She denied smoking and alcohol or recreational drug use.

In the ED, the patient had normal vital signs. Physical exam findings included bilateral scleral icterus and scattered skin excoriations on the hands, arms, back of the neck, and feet. At the time of hospital admission, the patient’s minocycline and birth control were held under the initial presumption that one or both might be contributing to her presentation.

Pertinent laboratory findings included aspartate transaminase (AST), 828 U/L (normal range, 2-40 U/L); alanine aminotransferase (ALT), 784 U/L (normal range, 3-30 U/L); lactic acid dehydrogenase, 520 U/L (normal range, 140-280 U/L); alkaline phosphatase, 119 U/L (normal range, 44-147 U/L); total bilirubin, 1.9 µmol/L (normal range, 2-18 µmol/L); and direct bilirubin, 1.3 µmol/L (normal range, 0-4 µmol/L). Baseline liver function test results (prior to admission) were unknown. Results of a coagulation panel, complete blood count, basic metabolic panel, amylase, lipase, urine toxicology, and urinalysis all were within normal limits.

Ultrasound of the abdomen revealed a normal abdomen, liver, pancreas, gallbladder, and common bile duct. This imaging study was negative for other obstructive pathologies.

THE DIAGNOSIS

During hospital admission, a noninvasive liver work-up was pursued by Gastroenterology. A hepatitis panel, Epstein-Barr virus testing, and levels of ceruloplasmin and acetaminophen were all found to be within normal limits, excluding additional causes of liver disease. Serum antinuclear antibody (ANA) testing was significantly positive, with a titer of 1:640 (range, < 1:20) and, as noted above, liver transaminases were severely elevated, leading to a presumptive diagnosis of drug-induced liver pathology.

Continue to: During outpatient follow-up...

During outpatient follow-up with Gastroenterology 2 days after discharge, the patient’s liver transaminases and bilirubin continued to trend upward (to a maximum ALT of 871 U/L; AST, 1097 U/L; alkaline phosphatase, 122 U/L; and bilirubin, 2.9 µmol/L). Immunoglobulin G was 1342 mg/mL (normal range, 694-1618 mg/mL).

An ultrasound-guided liver biopsy was performed; it demonstrated lobular, portal, and periportal hepatitis with focal bridging necrosis, consistent with a diagnosis of autoimmune hepatitis. Mild-to-moderate focal cholestasis was demonstrated, consistent with cholestatic hepatitis.

DISCUSSION

Autoimmune hepatitis is characterized by inflammation of the liver, secondary to the presence of circulating antibodies or hypergammaglobulinemia. The pathogenesis is thought to involve a T-cell–mediated immune attack on the liver. Based on case reports,the use of minocycline is associated with risk for liver injury, although the incidence is rare.^1-4 Use of this medication may be associated with autoimmune disease in patients who are predisposed to autoimmune tendencies or who have genetic predeterminants.

Diagnosis is typically made based on abnormalities in aminotransferases (AST, ALT), elevation in serum immunoglobulins, and positive auto-antibody titers including ANA, smooth muscle antibodies, and anti-liver kidney microsomal type 1 antibodies. Although clinical presentations tend to differ, the confirmatory diagnosis is typically made histologically, with the presence of lobular and perivenular necro-inflammatory changes and plasma cell infiltration.⁵

Other infectious and metabolic causes of hepatitis should be excluded. Many medications and herbal agents have been noted to cause autoimmune hepatitis or similar syndromes that mimic the condition.

Medication history. Review of the case patient’s medication list identified ethinyl estradiol/norethindrone acetate and minocycline as potential culprits. Ethinyl estradiol/norethindrone acetate is a low-dose combination oral contraceptive pill (OCP). Although earlier formulations of OCPs were associated with hepatobiliary complications, these adverse effects are noted to be rare in the absence of predisposing conditions.⁶ In some cases, OCPs have been linked to cholestasis, chronic hepatocellular carcinoma, or hepatic adenomas, but studies have shown that these medications do not affect the course of acute liver failure.⁷

Continue to: Minocycline...

Minocyclineassociated hepatotoxicity can be due to a systemic hypersensitivity reaction, occurring within a few weeks of therapy initiation, whereas autoimmune hepatitis manifests after a year or more of exposure to the medication.

In this case, given the patient’s 2-year history of minocycline use, it is possible that she developed an acute presentation of autoimmune hepatitis. With drug-induced autoimmune liver injury, complete resolution occurs after withdrawal of the offending medication, and a response to corticosteroid therapy supports the diagnosis. Recurrence of signs or symptoms following corticosteroid cessation may indicate idiopathic autoimmune hepatitis as opposed to a drug-induced form.²

Our patient was started on steroid and immunomodulator therapy, with prednisone 40 mg/d and mycophenolate 250 mg bid. At follow-up with Gastroenterology, the patient’s symptoms and liver function test results had improved significantly (AST, 27 U/L; ALT, 14 U/L; alkaline phosphatase, 51 U/L; and total bilirubin, 0.4 µmol/L). The patient was continued on a prednisone taper while simultaneously titrating mycophenolate. The ultimate plan of care included continuing mycophenolate for a total of 4 to 5 years.

THE TAKEAWAY

During evaluation of a patient with new-onset liver disease, it is important to inquire about prescription medications, drugs, vitamins, and herbal supplements as possible contributors to the disease process. This case highlights the importance of monitoring patients while on minocycline and of weighing the risks vs benefits of long-term therapy. It has been suggested that liver enzymes be tested before therapy initiation and about every 3 months during long-term antibiotic treatment.⁴ Careful consideration and caution should be taken prior to the initiation of medications that have been linked to rare, but important, adverse reactions.

ACKNOWLEDGEMENT

The authors would like to thank Frank Bauer, MD, and Eva Sotil, MD, for their contributions to this case presentation.

CORRESPONDENCE

Andrea Gillis, DO, Asylum Hill Family Medicine Center, 99 Woodland Street, Hartford, CT 06105; andrea.gillis@ trinityhealthofne.org

THE CASE

A 17-year-old White girl with no known past medical history presented to the emergency department (ED) with complaints of abdominal pain and pruritus. The abdominal pain had started 9 days prior and lasted for 3 days. One day after resolution, she developed bilateral lower extremity itching, which was not relieved with loratadine.

Review of systems included dark urine and yellow eyes noted for several days. The patient denied nausea, vomiting, diarrhea, constipation, fevers, chills, arthralgias, recent illness, travel, or sick contacts. Immunizations were up to date. The patient had no history of surgery or liver disease and no pertinent family history. Her current medications included ethinyl estradiol/norethindrone acetate for birth control and minocycline for acne vulgaris. She had been taking the latter medication for 2 years. No additional medications were noted, including vitamins, over-the-counter medications, or supplements. She denied smoking and alcohol or recreational drug use.

In the ED, the patient had normal vital signs. Physical exam findings included bilateral scleral icterus and scattered skin excoriations on the hands, arms, back of the neck, and feet. At the time of hospital admission, the patient’s minocycline and birth control were held under the initial presumption that one or both might be contributing to her presentation.

Pertinent laboratory findings included aspartate transaminase (AST), 828 U/L (normal range, 2-40 U/L); alanine aminotransferase (ALT), 784 U/L (normal range, 3-30 U/L); lactic acid dehydrogenase, 520 U/L (normal range, 140-280 U/L); alkaline phosphatase, 119 U/L (normal range, 44-147 U/L); total bilirubin, 1.9 µmol/L (normal range, 2-18 µmol/L); and direct bilirubin, 1.3 µmol/L (normal range, 0-4 µmol/L). Baseline liver function test results (prior to admission) were unknown. Results of a coagulation panel, complete blood count, basic metabolic panel, amylase, lipase, urine toxicology, and urinalysis all were within normal limits.

Ultrasound of the abdomen revealed a normal abdomen, liver, pancreas, gallbladder, and common bile duct. This imaging study was negative for other obstructive pathologies.

THE DIAGNOSIS

During hospital admission, a noninvasive liver work-up was pursued by Gastroenterology. A hepatitis panel, Epstein-Barr virus testing, and levels of ceruloplasmin and acetaminophen were all found to be within normal limits, excluding additional causes of liver disease. Serum antinuclear antibody (ANA) testing was significantly positive, with a titer of 1:640 (range, < 1:20) and, as noted above, liver transaminases were severely elevated, leading to a presumptive diagnosis of drug-induced liver pathology.

Continue to: During outpatient follow-up...

During outpatient follow-up with Gastroenterology 2 days after discharge, the patient’s liver transaminases and bilirubin continued to trend upward (to a maximum ALT of 871 U/L; AST, 1097 U/L; alkaline phosphatase, 122 U/L; and bilirubin, 2.9 µmol/L). Immunoglobulin G was 1342 mg/mL (normal range, 694-1618 mg/mL).

An ultrasound-guided liver biopsy was performed; it demonstrated lobular, portal, and periportal hepatitis with focal bridging necrosis, consistent with a diagnosis of autoimmune hepatitis. Mild-to-moderate focal cholestasis was demonstrated, consistent with cholestatic hepatitis.

DISCUSSION

Autoimmune hepatitis is characterized by inflammation of the liver, secondary to the presence of circulating antibodies or hypergammaglobulinemia. The pathogenesis is thought to involve a T-cell–mediated immune attack on the liver. Based on case reports,the use of minocycline is associated with risk for liver injury, although the incidence is rare.^1-4 Use of this medication may be associated with autoimmune disease in patients who are predisposed to autoimmune tendencies or who have genetic predeterminants.

Diagnosis is typically made based on abnormalities in aminotransferases (AST, ALT), elevation in serum immunoglobulins, and positive auto-antibody titers including ANA, smooth muscle antibodies, and anti-liver kidney microsomal type 1 antibodies. Although clinical presentations tend to differ, the confirmatory diagnosis is typically made histologically, with the presence of lobular and perivenular necro-inflammatory changes and plasma cell infiltration.⁵

Other infectious and metabolic causes of hepatitis should be excluded. Many medications and herbal agents have been noted to cause autoimmune hepatitis or similar syndromes that mimic the condition.

Medication history. Review of the case patient’s medication list identified ethinyl estradiol/norethindrone acetate and minocycline as potential culprits. Ethinyl estradiol/norethindrone acetate is a low-dose combination oral contraceptive pill (OCP). Although earlier formulations of OCPs were associated with hepatobiliary complications, these adverse effects are noted to be rare in the absence of predisposing conditions.⁶ In some cases, OCPs have been linked to cholestasis, chronic hepatocellular carcinoma, or hepatic adenomas, but studies have shown that these medications do not affect the course of acute liver failure.⁷

Continue to: Minocycline...

Minocyclineassociated hepatotoxicity can be due to a systemic hypersensitivity reaction, occurring within a few weeks of therapy initiation, whereas autoimmune hepatitis manifests after a year or more of exposure to the medication.

In this case, given the patient’s 2-year history of minocycline use, it is possible that she developed an acute presentation of autoimmune hepatitis. With drug-induced autoimmune liver injury, complete resolution occurs after withdrawal of the offending medication, and a response to corticosteroid therapy supports the diagnosis. Recurrence of signs or symptoms following corticosteroid cessation may indicate idiopathic autoimmune hepatitis as opposed to a drug-induced form.²

Our patient was started on steroid and immunomodulator therapy, with prednisone 40 mg/d and mycophenolate 250 mg bid. At follow-up with Gastroenterology, the patient’s symptoms and liver function test results had improved significantly (AST, 27 U/L; ALT, 14 U/L; alkaline phosphatase, 51 U/L; and total bilirubin, 0.4 µmol/L). The patient was continued on a prednisone taper while simultaneously titrating mycophenolate. The ultimate plan of care included continuing mycophenolate for a total of 4 to 5 years.

THE TAKEAWAY

During evaluation of a patient with new-onset liver disease, it is important to inquire about prescription medications, drugs, vitamins, and herbal supplements as possible contributors to the disease process. This case highlights the importance of monitoring patients while on minocycline and of weighing the risks vs benefits of long-term therapy. It has been suggested that liver enzymes be tested before therapy initiation and about every 3 months during long-term antibiotic treatment.⁴ Careful consideration and caution should be taken prior to the initiation of medications that have been linked to rare, but important, adverse reactions.

ACKNOWLEDGEMENT

The authors would like to thank Frank Bauer, MD, and Eva Sotil, MD, for their contributions to this case presentation.

CORRESPONDENCE

Andrea Gillis, DO, Asylum Hill Family Medicine Center, 99 Woodland Street, Hartford, CT 06105; andrea.gillis@ trinityhealthofne.org

An analysis of nearly 29,000 U.S. women with early-onset colorectal cancer (CRC) showed that physical inactivity and fertility correlated modestly with living in “hot spots,” or counties with high early-onset CRC mortality rates among women.

Approximately one-third of the variation in early-onset CRC survival among women was accounted for by differences in individual- or community-level features.

Andreana N. Holowatyj, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues reported these findings in Clinical and Translational Gastroenterology.

Dr. Holowatyj and colleagues noted that prior studies have linked health behaviors with an increased risk of early-onset CRC among women. However, the impact of health behaviors on outcomes of early-onset CRC is unknown.

The researchers hypothesized that biological-, individual-, and community-level factors may be contributing to known sex-specific differences in CRC outcomes and geographic variations in survival by sex.
 

Hot spot counties with high mortality

The researchers identified geographic hot spots using three geospatial autocorrelation approaches with Centers for Disease Control and Prevention national

mortality data. The team also analyzed data from the Surveillance, Epidemiology, and End Results program on 28,790 women (aged 15-49 years) diagnosed with CRC during 1999-2016.

Of the 3,108 counties in the contiguous United States, 191 were identified as hot spots. Among these, 101 (52.9%) were located in the South.

Earlier research had shown a predominance of hot spots for early-onset CRC mortality among both men and women in the South.

However, the current study of women showed that almost half of these counties were located in the Midwest and the Northeast as well as the South.

Also in the current analysis, about one in every seven women (13.7%) with early-onset CRC resided in hot spot counties.

Race/ethnicity, stage at diagnosis, histopathology, and receipt of first-course therapies also differed significantly (P ≤ .0001) between women residing in hot spot versus non–hot spot counties.

Non-Hispanic Black patients, for example, accounted for 23.7% of early-onset CRC cases in hot spot counties, as compared with 14.3% in non–hot spot counties (P < .0001). The county-level proportion of non-Hispanic Black patients also modestly correlated with hot spot residence (r_s = .26; P < .0001).

Race and ethnicity accounted for less than 0.5% of the variation in early-onset CRC survival among women in non–hot spot counties. In hot spot counties, however, this factor explained 1.4% of the variation in early-onset CRC-specific survival among women.
 

Inactivity correlates with hot spot residence

Dr. Holowatyj and colleagues also identified physical inactivity and lower fertility as county-level factors modestly correlated with hot spot residence (r_s = .21, r_s = –.23: P < .01).

Nearly a quarter of adults living in hot spot counties reported no physical activity during their leisure time (24.1% vs. 21.7% in non–hot spot counties; P < .01).

The rate of live births in the last year among women aged 15-50 years was lower in hot spot counties than in non–hot spot counties (4.9% vs. 5.4%; P < .01).

Individual- and community-level features overall accounted for different proportions of variance in early-onset CRC survival among women residing in hot spot counties (33.8%) versus non–hot spot counties (34.1%).

In addition to race and ethnicity, age at diagnosis, tumor histology, county-level proportions of the non-Hispanic Black population, women with a live birth in the last year, and annual household income of less than $20,000 all explained greater variance in CRC survival in young women in hot spot counties versus non–hot spot counties.
 

Keep CRC in differential diagnosis

“These individual- and community-level feature differences between hot spot and non–hot spot counties illustrate the importance of understanding how these factors may be contributing to early-onset CRC mortality among women – particularly in hot spot counties,” Dr. Holowatyj said in an interview. “They may provide us with key clues for developing effective strategies to reduce the burden of CRC in young women across the United States.

“Every primary care physician and gastroenterologist, particularly in hot spot counties, should keep CRC in their differential diagnosis, particularly if a patient is presenting with typical signs and symptoms, even if they are not yet of screening age. Early-stage diagnosis increases survival odds because the cancer may be easier to treat.”

Health professionals can also encourage physical activity and a healthy lifestyle, she added.

The authors declared no competing interests. Their research was funded by grants from the federal government and foundations.

SOURCE: Holowatyj AN et al. Clin and Transl Gastroenterol. 2020;11:e00266.

An analysis of nearly 29,000 U.S. women with early-onset colorectal cancer (CRC) showed that physical inactivity and fertility correlated modestly with living in “hot spots,” or counties with high early-onset CRC mortality rates among women.

Approximately one-third of the variation in early-onset CRC survival among women was accounted for by differences in individual- or community-level features.

Andreana N. Holowatyj, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues reported these findings in Clinical and Translational Gastroenterology.

Dr. Holowatyj and colleagues noted that prior studies have linked health behaviors with an increased risk of early-onset CRC among women. However, the impact of health behaviors on outcomes of early-onset CRC is unknown.

The researchers hypothesized that biological-, individual-, and community-level factors may be contributing to known sex-specific differences in CRC outcomes and geographic variations in survival by sex.
 

Hot spot counties with high mortality

The researchers identified geographic hot spots using three geospatial autocorrelation approaches with Centers for Disease Control and Prevention national

mortality data. The team also analyzed data from the Surveillance, Epidemiology, and End Results program on 28,790 women (aged 15-49 years) diagnosed with CRC during 1999-2016.

Of the 3,108 counties in the contiguous United States, 191 were identified as hot spots. Among these, 101 (52.9%) were located in the South.

Earlier research had shown a predominance of hot spots for early-onset CRC mortality among both men and women in the South.

However, the current study of women showed that almost half of these counties were located in the Midwest and the Northeast as well as the South.

Also in the current analysis, about one in every seven women (13.7%) with early-onset CRC resided in hot spot counties.

Race/ethnicity, stage at diagnosis, histopathology, and receipt of first-course therapies also differed significantly (P ≤ .0001) between women residing in hot spot versus non–hot spot counties.

Non-Hispanic Black patients, for example, accounted for 23.7% of early-onset CRC cases in hot spot counties, as compared with 14.3% in non–hot spot counties (P < .0001). The county-level proportion of non-Hispanic Black patients also modestly correlated with hot spot residence (r_s = .26; P < .0001).

Race and ethnicity accounted for less than 0.5% of the variation in early-onset CRC survival among women in non–hot spot counties. In hot spot counties, however, this factor explained 1.4% of the variation in early-onset CRC-specific survival among women.
 

Inactivity correlates with hot spot residence

Dr. Holowatyj and colleagues also identified physical inactivity and lower fertility as county-level factors modestly correlated with hot spot residence (r_s = .21, r_s = –.23: P < .01).

Nearly a quarter of adults living in hot spot counties reported no physical activity during their leisure time (24.1% vs. 21.7% in non–hot spot counties; P < .01).

The rate of live births in the last year among women aged 15-50 years was lower in hot spot counties than in non–hot spot counties (4.9% vs. 5.4%; P < .01).

Individual- and community-level features overall accounted for different proportions of variance in early-onset CRC survival among women residing in hot spot counties (33.8%) versus non–hot spot counties (34.1%).

In addition to race and ethnicity, age at diagnosis, tumor histology, county-level proportions of the non-Hispanic Black population, women with a live birth in the last year, and annual household income of less than $20,000 all explained greater variance in CRC survival in young women in hot spot counties versus non–hot spot counties.
 

Keep CRC in differential diagnosis

“These individual- and community-level feature differences between hot spot and non–hot spot counties illustrate the importance of understanding how these factors may be contributing to early-onset CRC mortality among women – particularly in hot spot counties,” Dr. Holowatyj said in an interview. “They may provide us with key clues for developing effective strategies to reduce the burden of CRC in young women across the United States.

“Every primary care physician and gastroenterologist, particularly in hot spot counties, should keep CRC in their differential diagnosis, particularly if a patient is presenting with typical signs and symptoms, even if they are not yet of screening age. Early-stage diagnosis increases survival odds because the cancer may be easier to treat.”

Health professionals can also encourage physical activity and a healthy lifestyle, she added.

The authors declared no competing interests. Their research was funded by grants from the federal government and foundations.

SOURCE: Holowatyj AN et al. Clin and Transl Gastroenterol. 2020;11:e00266.

An analysis of nearly 29,000 U.S. women with early-onset colorectal cancer (CRC) showed that physical inactivity and fertility correlated modestly with living in “hot spots,” or counties with high early-onset CRC mortality rates among women.

Approximately one-third of the variation in early-onset CRC survival among women was accounted for by differences in individual- or community-level features.

Andreana N. Holowatyj, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues reported these findings in Clinical and Translational Gastroenterology.

Dr. Holowatyj and colleagues noted that prior studies have linked health behaviors with an increased risk of early-onset CRC among women. However, the impact of health behaviors on outcomes of early-onset CRC is unknown.

The researchers hypothesized that biological-, individual-, and community-level factors may be contributing to known sex-specific differences in CRC outcomes and geographic variations in survival by sex.
 

Hot spot counties with high mortality

The researchers identified geographic hot spots using three geospatial autocorrelation approaches with Centers for Disease Control and Prevention national

mortality data. The team also analyzed data from the Surveillance, Epidemiology, and End Results program on 28,790 women (aged 15-49 years) diagnosed with CRC during 1999-2016.

Of the 3,108 counties in the contiguous United States, 191 were identified as hot spots. Among these, 101 (52.9%) were located in the South.

Earlier research had shown a predominance of hot spots for early-onset CRC mortality among both men and women in the South.

However, the current study of women showed that almost half of these counties were located in the Midwest and the Northeast as well as the South.

Also in the current analysis, about one in every seven women (13.7%) with early-onset CRC resided in hot spot counties.

Race/ethnicity, stage at diagnosis, histopathology, and receipt of first-course therapies also differed significantly (P ≤ .0001) between women residing in hot spot versus non–hot spot counties.

Non-Hispanic Black patients, for example, accounted for 23.7% of early-onset CRC cases in hot spot counties, as compared with 14.3% in non–hot spot counties (P < .0001). The county-level proportion of non-Hispanic Black patients also modestly correlated with hot spot residence (r_s = .26; P < .0001).

Race and ethnicity accounted for less than 0.5% of the variation in early-onset CRC survival among women in non–hot spot counties. In hot spot counties, however, this factor explained 1.4% of the variation in early-onset CRC-specific survival among women.
 

Inactivity correlates with hot spot residence

Dr. Holowatyj and colleagues also identified physical inactivity and lower fertility as county-level factors modestly correlated with hot spot residence (r_s = .21, r_s = –.23: P < .01).

Nearly a quarter of adults living in hot spot counties reported no physical activity during their leisure time (24.1% vs. 21.7% in non–hot spot counties; P < .01).

The rate of live births in the last year among women aged 15-50 years was lower in hot spot counties than in non–hot spot counties (4.9% vs. 5.4%; P < .01).

Individual- and community-level features overall accounted for different proportions of variance in early-onset CRC survival among women residing in hot spot counties (33.8%) versus non–hot spot counties (34.1%).

In addition to race and ethnicity, age at diagnosis, tumor histology, county-level proportions of the non-Hispanic Black population, women with a live birth in the last year, and annual household income of less than $20,000 all explained greater variance in CRC survival in young women in hot spot counties versus non–hot spot counties.
 

Keep CRC in differential diagnosis

“These individual- and community-level feature differences between hot spot and non–hot spot counties illustrate the importance of understanding how these factors may be contributing to early-onset CRC mortality among women – particularly in hot spot counties,” Dr. Holowatyj said in an interview. “They may provide us with key clues for developing effective strategies to reduce the burden of CRC in young women across the United States.

“Every primary care physician and gastroenterologist, particularly in hot spot counties, should keep CRC in their differential diagnosis, particularly if a patient is presenting with typical signs and symptoms, even if they are not yet of screening age. Early-stage diagnosis increases survival odds because the cancer may be easier to treat.”

Health professionals can also encourage physical activity and a healthy lifestyle, she added.

The authors declared no competing interests. Their research was funded by grants from the federal government and foundations.

SOURCE: Holowatyj AN et al. Clin and Transl Gastroenterol. 2020;11:e00266.

EVIDENCE SUMMARY

Two recent multicenter, open-label RCTs, 1 in the United States and 1 in Norway, compared monthly XR-NTX with daily BUP-NX.^1,2 Both studies evaluated effectiveness (defined by either the number of people who relapsed or self-reported opioid use), cravings, and safety (defined as the absence of serious adverse events such as medically complex withdrawal or fatal overdose).

The participant populations were similar in both mean age and mean age of onset of opioid use. Duration of opioid use was reported differently (total duration or years of heavy heroin or other opioid use) and couldn’t be compared directly.

Naltrexone and buprenorphine-naloxone are similarly effective

The US study enrolled 570 opioid-dependent participants in a 24-week comparative effectiveness trial.¹ The 8 study sites were community treatment programs, and the participants were recruited during voluntary inpatient detoxification admissions. Some participants were randomized while on methadone or buprenorphine tapers and some after complete detoxification.

The intention-to-treat analysis included 283 patients in the XR-NTX group and 287 in the BUP-NX group. At 24 weeks, the number of participants who’d had a relapse event (self-reported use or positive urine drug test for nonstudy opioids or refusal to provide a urine sample) was 185 (65%) for XR-NTX compared with 163 (57%) for BUP-NX (odds ratio [OR] = 1.44, 95% confidence interval [CI], 1.02 to 2.01; P = .036).

The 12-week Norwegian noninferiority trial enrolled 159 participants.² In contrast to the US study, all participants were required to complete inpatient detoxification before randomization and induction onto the study medication.

Patients on BUP-NX reported 3.6 more days of heroin use within the previous 28 days than patients in the XR-NTX group (95% CI, 1.2 to 6; P = .003). For other illicit opioids, self-reported use was 2.4 days greater in the BUP-NX group (95% CI, −0.1 to 4.9; P = .06). Retention with XR-NTX was noninferior to BUP-NX (mean days in therapy [standard deviation], 69.3 [25.9] and 63.7 [29.9]; P = .33).

Randomizing after complete detox reduces induction failures

Naltrexone, a full opioid antagonist, precipitates withdrawal when a full or partial opioid agonist is engaging the opioid receptor. For this reason, an opioid-free interval of 7 to 10 days is generally recommended before initiating naltrexone, raising the risk for relapse during the induction process.

Continue to: The Norwegian trial...

The Norwegian trial randomized participants after detoxification. The US trial, in which some participants were randomized before completing detoxification, reported 79 (28%) induction failures for XR-NTX and 17 (6%) for BUP-NX.¹ As a result, a per protocol analysis was completed with the 204 patients on XR-NTX and 270 patients on BUP-NX who were successfully inducted onto a study medication. The 24-week relapse rate was 52% (106) for XR-NTX and 56% (150) for BUP-NX (OR = 0.87; 95% CI, 0.60 to 1.25; P = .44).

Cravings, adverse events, and cost considerations

Patients reported cravings using a visual analog scale. At 12 weeks in both studies, the XR-NTX groups reported fewer cravings than the BUP-NX groups, although by the end of the 24-week US trial, no statistically significant difference in cravings was found between the 2 groups.^1,2

The Norwegian trial found a difference between the XR-NTX and the BUP-NX groups in the percentage of nonserious adverse events such as nausea or chills (60.6% in the XR-NTX group vs 30.6% in the BUP-NX group; P < .001), and the US trial found a difference in total number of overdoses (64% of the total overdoses were in the XR-NTX group). Neither trial, however, reported a statistically significant difference in serious adverse events or fatal overdoses between the 2 groups.^1,2

The price for naltrexone is $1665.06 per monthly injection.³ The price for buprenorphine-naloxone varies depending on dose and formulation, with a general range of $527 to $600 per month at 16 mg/d.⁴

Editor’s takeaway

Two higher-quality RCTs show similar but imperfect effectiveness for both XR-NTX and daily sublingual BUP-NX. Injectable naltrexone’s higher cost may influence medication choice.

EVIDENCE SUMMARY

Two recent multicenter, open-label RCTs, 1 in the United States and 1 in Norway, compared monthly XR-NTX with daily BUP-NX.^1,2 Both studies evaluated effectiveness (defined by either the number of people who relapsed or self-reported opioid use), cravings, and safety (defined as the absence of serious adverse events such as medically complex withdrawal or fatal overdose).

The participant populations were similar in both mean age and mean age of onset of opioid use. Duration of opioid use was reported differently (total duration or years of heavy heroin or other opioid use) and couldn’t be compared directly.

Naltrexone and buprenorphine-naloxone are similarly effective

The US study enrolled 570 opioid-dependent participants in a 24-week comparative effectiveness trial.¹ The 8 study sites were community treatment programs, and the participants were recruited during voluntary inpatient detoxification admissions. Some participants were randomized while on methadone or buprenorphine tapers and some after complete detoxification.

The intention-to-treat analysis included 283 patients in the XR-NTX group and 287 in the BUP-NX group. At 24 weeks, the number of participants who’d had a relapse event (self-reported use or positive urine drug test for nonstudy opioids or refusal to provide a urine sample) was 185 (65%) for XR-NTX compared with 163 (57%) for BUP-NX (odds ratio [OR] = 1.44, 95% confidence interval [CI], 1.02 to 2.01; P = .036).

The 12-week Norwegian noninferiority trial enrolled 159 participants.² In contrast to the US study, all participants were required to complete inpatient detoxification before randomization and induction onto the study medication.

Patients on BUP-NX reported 3.6 more days of heroin use within the previous 28 days than patients in the XR-NTX group (95% CI, 1.2 to 6; P = .003). For other illicit opioids, self-reported use was 2.4 days greater in the BUP-NX group (95% CI, −0.1 to 4.9; P = .06). Retention with XR-NTX was noninferior to BUP-NX (mean days in therapy [standard deviation], 69.3 [25.9] and 63.7 [29.9]; P = .33).

Randomizing after complete detox reduces induction failures

Naltrexone, a full opioid antagonist, precipitates withdrawal when a full or partial opioid agonist is engaging the opioid receptor. For this reason, an opioid-free interval of 7 to 10 days is generally recommended before initiating naltrexone, raising the risk for relapse during the induction process.

Continue to: The Norwegian trial...

The Norwegian trial randomized participants after detoxification. The US trial, in which some participants were randomized before completing detoxification, reported 79 (28%) induction failures for XR-NTX and 17 (6%) for BUP-NX.¹ As a result, a per protocol analysis was completed with the 204 patients on XR-NTX and 270 patients on BUP-NX who were successfully inducted onto a study medication. The 24-week relapse rate was 52% (106) for XR-NTX and 56% (150) for BUP-NX (OR = 0.87; 95% CI, 0.60 to 1.25; P = .44).

Cravings, adverse events, and cost considerations

Patients reported cravings using a visual analog scale. At 12 weeks in both studies, the XR-NTX groups reported fewer cravings than the BUP-NX groups, although by the end of the 24-week US trial, no statistically significant difference in cravings was found between the 2 groups.^1,2

The Norwegian trial found a difference between the XR-NTX and the BUP-NX groups in the percentage of nonserious adverse events such as nausea or chills (60.6% in the XR-NTX group vs 30.6% in the BUP-NX group; P < .001), and the US trial found a difference in total number of overdoses (64% of the total overdoses were in the XR-NTX group). Neither trial, however, reported a statistically significant difference in serious adverse events or fatal overdoses between the 2 groups.^1,2

The price for naltrexone is $1665.06 per monthly injection.³ The price for buprenorphine-naloxone varies depending on dose and formulation, with a general range of $527 to $600 per month at 16 mg/d.⁴

Editor’s takeaway

Two higher-quality RCTs show similar but imperfect effectiveness for both XR-NTX and daily sublingual BUP-NX. Injectable naltrexone’s higher cost may influence medication choice.

EVIDENCE SUMMARY

Two recent multicenter, open-label RCTs, 1 in the United States and 1 in Norway, compared monthly XR-NTX with daily BUP-NX.^1,2 Both studies evaluated effectiveness (defined by either the number of people who relapsed or self-reported opioid use), cravings, and safety (defined as the absence of serious adverse events such as medically complex withdrawal or fatal overdose).

The participant populations were similar in both mean age and mean age of onset of opioid use. Duration of opioid use was reported differently (total duration or years of heavy heroin or other opioid use) and couldn’t be compared directly.

Naltrexone and buprenorphine-naloxone are similarly effective

The US study enrolled 570 opioid-dependent participants in a 24-week comparative effectiveness trial.¹ The 8 study sites were community treatment programs, and the participants were recruited during voluntary inpatient detoxification admissions. Some participants were randomized while on methadone or buprenorphine tapers and some after complete detoxification.

The intention-to-treat analysis included 283 patients in the XR-NTX group and 287 in the BUP-NX group. At 24 weeks, the number of participants who’d had a relapse event (self-reported use or positive urine drug test for nonstudy opioids or refusal to provide a urine sample) was 185 (65%) for XR-NTX compared with 163 (57%) for BUP-NX (odds ratio [OR] = 1.44, 95% confidence interval [CI], 1.02 to 2.01; P = .036).

The 12-week Norwegian noninferiority trial enrolled 159 participants.² In contrast to the US study, all participants were required to complete inpatient detoxification before randomization and induction onto the study medication.

Patients on BUP-NX reported 3.6 more days of heroin use within the previous 28 days than patients in the XR-NTX group (95% CI, 1.2 to 6; P = .003). For other illicit opioids, self-reported use was 2.4 days greater in the BUP-NX group (95% CI, −0.1 to 4.9; P = .06). Retention with XR-NTX was noninferior to BUP-NX (mean days in therapy [standard deviation], 69.3 [25.9] and 63.7 [29.9]; P = .33).

Randomizing after complete detox reduces induction failures

Naltrexone, a full opioid antagonist, precipitates withdrawal when a full or partial opioid agonist is engaging the opioid receptor. For this reason, an opioid-free interval of 7 to 10 days is generally recommended before initiating naltrexone, raising the risk for relapse during the induction process.

Continue to: The Norwegian trial...

The Norwegian trial randomized participants after detoxification. The US trial, in which some participants were randomized before completing detoxification, reported 79 (28%) induction failures for XR-NTX and 17 (6%) for BUP-NX.¹ As a result, a per protocol analysis was completed with the 204 patients on XR-NTX and 270 patients on BUP-NX who were successfully inducted onto a study medication. The 24-week relapse rate was 52% (106) for XR-NTX and 56% (150) for BUP-NX (OR = 0.87; 95% CI, 0.60 to 1.25; P = .44).

Cravings, adverse events, and cost considerations

Patients reported cravings using a visual analog scale. At 12 weeks in both studies, the XR-NTX groups reported fewer cravings than the BUP-NX groups, although by the end of the 24-week US trial, no statistically significant difference in cravings was found between the 2 groups.^1,2

The Norwegian trial found a difference between the XR-NTX and the BUP-NX groups in the percentage of nonserious adverse events such as nausea or chills (60.6% in the XR-NTX group vs 30.6% in the BUP-NX group; P < .001), and the US trial found a difference in total number of overdoses (64% of the total overdoses were in the XR-NTX group). Neither trial, however, reported a statistically significant difference in serious adverse events or fatal overdoses between the 2 groups.^1,2

The price for naltrexone is $1665.06 per monthly injection.³ The price for buprenorphine-naloxone varies depending on dose and formulation, with a general range of $527 to $600 per month at 16 mg/d.⁴

Editor’s takeaway

Two higher-quality RCTs show similar but imperfect effectiveness for both XR-NTX and daily sublingual BUP-NX. Injectable naltrexone’s higher cost may influence medication choice.

The U.S. Surgeon General and Department of Health & Human Services are calling on health care professionals, hospitals, employers, insurers, women, and the nation to work together to reduce maternal morbidity and mortality – and the disparities that make the risks higher for women of color.

The maternal mortality rate in the United States is the highest among developed countries of the world and continues to rise. In 2018, for every 100,000 live births, approximately 17 women died while pregnant or within 42 days of the end of pregnancy from causes related to pregnancy or delivery – that’s a substantial increase from 7 deaths per 100,000 live births in 1987, according to the surgeon general’s new call to action.

“Our mothers had much lower rates of dying related to pregnancy, compared to women today,” Dorothy Fink, MD, HHS deputy assistant secretary for women’s health, said at a briefing held Dec. 3 to mark the call to action.

Cardiovascular conditions were the most common cause of pregnancy-related deaths between 2011 and 2015, accounting for more than one in three of the deaths. HHS’s related action plan sets a target of achieving blood pressure control in 80% of women of reproductive age with hypertension by 2025.

The plan also seeks to reduce the maternal mortality rate by 50% and decrease low-risk cesarean deliveries by 25% within 5 years.

“A woman dies every 12 hours in this country from pregnancy-related complications,” Surgeon General Jerome Adams, MD, said at the briefing. “This is not just unacceptable, it is just something that we need to understand is not inevitable,” he said, adding that the Centers for Disease Control and Prevention has determined that two thirds of the deaths are preventable.

Dr. Adams also noted that it was important to address maternal health now, especially with COVID-19 raging. “Without attention and action, maternal health could actually worsen because of this pandemic,” he said.

“We cannot discuss maternal health, much less improve it, unless we acknowledge women of color are at a much greater risk of harm related to childbirth,” Dr. Adams said. “Black women are two to three times more likely to die of pregnancy-related causes compared to many other racial and ethnic groups.” The disparity increases with age, according to the CDC.

Studies have shown that education does not eliminate those disparities. Black women with a college degree are twice as likely to die as White or Asian American women who did not finish high school, Dr. Adams said.

He held up a photo of a colleague, Shalone Irving, who he said was a PhD-educated epidemiologist who “died not long ago from pregnancy-related complications.”

Income is also not a factor, said Dr. Adams, noting that pop singer Beyonce had a near-death experience with preeclampsia. He also noted that Serena Williams, a top athlete, also struggled with pregnancy complications.
 

Recommendations not all funded

The HHS action plan is not explicitly funded, although Dr. Fink and Dr. Adams said that President Donald J. Trump’s fiscal 2021 budget includes some specific requests for improving maternal health. It will be up to Congress to grant the requests.

The budget seeks $80 million for the Health Resources and Services Administration to improve access to and quality of care. It also includes money to expand Medicaid coverage for 1 year after birth for women with substance use disorders. The American Medical Association in 2019 adopted a policy urging Medicaid coverage to be expanded to include all women for a year after childbirth. The American College of Obstetricians and Gynecologists has also encouraged this extension.

“We are encouraged that the HHS action plan includes support for policies to close coverage and care gaps for all postpartum women after pregnancy-related Medicaid coverage expires,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in an interview.

The HHS could act immediately by approving Medicaid waivers to extend such coverage, Dr. Phipps said.

The budget also requests $24 million to expand maternal mortality review programs to every state, said Dr. Fink. Currently, 43 states and the District of Columbia, have such committees, which are charged with reviewing deaths of women within a year of pregnancy or birth.

The HHS will also join with the March of Dimes to address the disparities in Black women by implementing evidence-based best practices to improve quality in hospital settings.

It is not the first time the Trump administration has taken aim at reducing maternal morbidity and mortality. In 2018, the president signed the Preventing Maternal Deaths Act, which authorized the CDC to award $50 million over 5 years so that every state could form maternal mortality review committees.

A version of this article originally appeared on Medscape.com.

The U.S. Surgeon General and Department of Health & Human Services are calling on health care professionals, hospitals, employers, insurers, women, and the nation to work together to reduce maternal morbidity and mortality – and the disparities that make the risks higher for women of color.

The maternal mortality rate in the United States is the highest among developed countries of the world and continues to rise. In 2018, for every 100,000 live births, approximately 17 women died while pregnant or within 42 days of the end of pregnancy from causes related to pregnancy or delivery – that’s a substantial increase from 7 deaths per 100,000 live births in 1987, according to the surgeon general’s new call to action.

“Our mothers had much lower rates of dying related to pregnancy, compared to women today,” Dorothy Fink, MD, HHS deputy assistant secretary for women’s health, said at a briefing held Dec. 3 to mark the call to action.

Cardiovascular conditions were the most common cause of pregnancy-related deaths between 2011 and 2015, accounting for more than one in three of the deaths. HHS’s related action plan sets a target of achieving blood pressure control in 80% of women of reproductive age with hypertension by 2025.

The plan also seeks to reduce the maternal mortality rate by 50% and decrease low-risk cesarean deliveries by 25% within 5 years.

“A woman dies every 12 hours in this country from pregnancy-related complications,” Surgeon General Jerome Adams, MD, said at the briefing. “This is not just unacceptable, it is just something that we need to understand is not inevitable,” he said, adding that the Centers for Disease Control and Prevention has determined that two thirds of the deaths are preventable.

Dr. Adams also noted that it was important to address maternal health now, especially with COVID-19 raging. “Without attention and action, maternal health could actually worsen because of this pandemic,” he said.

“We cannot discuss maternal health, much less improve it, unless we acknowledge women of color are at a much greater risk of harm related to childbirth,” Dr. Adams said. “Black women are two to three times more likely to die of pregnancy-related causes compared to many other racial and ethnic groups.” The disparity increases with age, according to the CDC.

Studies have shown that education does not eliminate those disparities. Black women with a college degree are twice as likely to die as White or Asian American women who did not finish high school, Dr. Adams said.

He held up a photo of a colleague, Shalone Irving, who he said was a PhD-educated epidemiologist who “died not long ago from pregnancy-related complications.”

Income is also not a factor, said Dr. Adams, noting that pop singer Beyonce had a near-death experience with preeclampsia. He also noted that Serena Williams, a top athlete, also struggled with pregnancy complications.
 

Recommendations not all funded

The HHS action plan is not explicitly funded, although Dr. Fink and Dr. Adams said that President Donald J. Trump’s fiscal 2021 budget includes some specific requests for improving maternal health. It will be up to Congress to grant the requests.

The budget seeks $80 million for the Health Resources and Services Administration to improve access to and quality of care. It also includes money to expand Medicaid coverage for 1 year after birth for women with substance use disorders. The American Medical Association in 2019 adopted a policy urging Medicaid coverage to be expanded to include all women for a year after childbirth. The American College of Obstetricians and Gynecologists has also encouraged this extension.

“We are encouraged that the HHS action plan includes support for policies to close coverage and care gaps for all postpartum women after pregnancy-related Medicaid coverage expires,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in an interview.

The HHS could act immediately by approving Medicaid waivers to extend such coverage, Dr. Phipps said.

The budget also requests $24 million to expand maternal mortality review programs to every state, said Dr. Fink. Currently, 43 states and the District of Columbia, have such committees, which are charged with reviewing deaths of women within a year of pregnancy or birth.

The HHS will also join with the March of Dimes to address the disparities in Black women by implementing evidence-based best practices to improve quality in hospital settings.

It is not the first time the Trump administration has taken aim at reducing maternal morbidity and mortality. In 2018, the president signed the Preventing Maternal Deaths Act, which authorized the CDC to award $50 million over 5 years so that every state could form maternal mortality review committees.

A version of this article originally appeared on Medscape.com.

The U.S. Surgeon General and Department of Health & Human Services are calling on health care professionals, hospitals, employers, insurers, women, and the nation to work together to reduce maternal morbidity and mortality – and the disparities that make the risks higher for women of color.

The maternal mortality rate in the United States is the highest among developed countries of the world and continues to rise. In 2018, for every 100,000 live births, approximately 17 women died while pregnant or within 42 days of the end of pregnancy from causes related to pregnancy or delivery – that’s a substantial increase from 7 deaths per 100,000 live births in 1987, according to the surgeon general’s new call to action.

“Our mothers had much lower rates of dying related to pregnancy, compared to women today,” Dorothy Fink, MD, HHS deputy assistant secretary for women’s health, said at a briefing held Dec. 3 to mark the call to action.

Cardiovascular conditions were the most common cause of pregnancy-related deaths between 2011 and 2015, accounting for more than one in three of the deaths. HHS’s related action plan sets a target of achieving blood pressure control in 80% of women of reproductive age with hypertension by 2025.

The plan also seeks to reduce the maternal mortality rate by 50% and decrease low-risk cesarean deliveries by 25% within 5 years.

“A woman dies every 12 hours in this country from pregnancy-related complications,” Surgeon General Jerome Adams, MD, said at the briefing. “This is not just unacceptable, it is just something that we need to understand is not inevitable,” he said, adding that the Centers for Disease Control and Prevention has determined that two thirds of the deaths are preventable.

Dr. Adams also noted that it was important to address maternal health now, especially with COVID-19 raging. “Without attention and action, maternal health could actually worsen because of this pandemic,” he said.

“We cannot discuss maternal health, much less improve it, unless we acknowledge women of color are at a much greater risk of harm related to childbirth,” Dr. Adams said. “Black women are two to three times more likely to die of pregnancy-related causes compared to many other racial and ethnic groups.” The disparity increases with age, according to the CDC.

Studies have shown that education does not eliminate those disparities. Black women with a college degree are twice as likely to die as White or Asian American women who did not finish high school, Dr. Adams said.

He held up a photo of a colleague, Shalone Irving, who he said was a PhD-educated epidemiologist who “died not long ago from pregnancy-related complications.”

Income is also not a factor, said Dr. Adams, noting that pop singer Beyonce had a near-death experience with preeclampsia. He also noted that Serena Williams, a top athlete, also struggled with pregnancy complications.
 

Recommendations not all funded

The HHS action plan is not explicitly funded, although Dr. Fink and Dr. Adams said that President Donald J. Trump’s fiscal 2021 budget includes some specific requests for improving maternal health. It will be up to Congress to grant the requests.

The budget seeks $80 million for the Health Resources and Services Administration to improve access to and quality of care. It also includes money to expand Medicaid coverage for 1 year after birth for women with substance use disorders. The American Medical Association in 2019 adopted a policy urging Medicaid coverage to be expanded to include all women for a year after childbirth. The American College of Obstetricians and Gynecologists has also encouraged this extension.

“We are encouraged that the HHS action plan includes support for policies to close coverage and care gaps for all postpartum women after pregnancy-related Medicaid coverage expires,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in an interview.

The HHS could act immediately by approving Medicaid waivers to extend such coverage, Dr. Phipps said.

The budget also requests $24 million to expand maternal mortality review programs to every state, said Dr. Fink. Currently, 43 states and the District of Columbia, have such committees, which are charged with reviewing deaths of women within a year of pregnancy or birth.

The HHS will also join with the March of Dimes to address the disparities in Black women by implementing evidence-based best practices to improve quality in hospital settings.

It is not the first time the Trump administration has taken aim at reducing maternal morbidity and mortality. In 2018, the president signed the Preventing Maternal Deaths Act, which authorized the CDC to award $50 million over 5 years so that every state could form maternal mortality review committees.

A version of this article originally appeared on Medscape.com.

From the UT Health Long School of Medicine San Antonio, Texas.

Abstract

Objective: To educate pregnant patients with opioid use disorder (OUD) about the effects of opioids in order to improve understanding and help achieve sustained abstinence.

Methods: The Center for Health Care Services and University Hospital System (UHS) in San Antonio, TX, jointly operate a methadone clinic, the Mommies Program, for pregnant women with OUD. As part of this program, medical students discuss methadone use in pregnancy and the health effects of OUD on mother and child and review resources for sustained peripartum abstinence at prenatal visits with pregnant patients with OUD concurrently enrolled in the program. To evaluate the impact of this education intervention, students assessed patients’ knowledge of methadone effects on mother and baby, state laws concerning heroin and methadone use in pregnancy, and motivation to quit using opioids with pre- and post-intervention surveys.

Results: Of 68 women enrolled in the program, 33 completed both the pre-survey and the post-survey (48.5%). Nearly half (48%) were very motivated to quit before pregnancy, but 85% were very motivated to quit once pregnant. All participants said learning more about the effects of opiates would increase motivation for sobriety. Prior to the educational intervention, 39% of participants knew it was safe to breastfeed on methadone, which improved to 97% in the post-survey, and 76% incorrectly thought they would be reported to authorities by their health care providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so.

Conclusion: Pregnancy and education about opioids increased patients’ motivation to quit. Patients also advanced their breastfeeding knowledge and learned about patient-provider confidentiality. Our greatest challenge was participant follow-up; however, this improved with the help of a full-time Mommies Program nurse. Our future aim is to increase project awareness and extend the educational research.

Keywords: pregnancy; addiction; opioids; OUD; counseling.

In 2012 more than 259 million prescriptions for opioids were written in the United States, which was a 200% increase since 1998.¹ Since the early 2000s, admissions to opioid substance abuse programs and the death rate from opioids have quadrupled.^2-4 Specifically, the rate of heroin use increased more than 300% from 2010 to 2014.⁵ Opioid use in pregnancy has also escalated in recent years, with a 3- to 4-fold increase from 2000 to 2009 and with 4 in 1000 deliveries being complicated by opioid use disorder (OUD) in 2011.^6-8

Between 2000 and 2014, the maternal mortality rate in the United States increased 24%, making it the only industrialized nation with a maternal mortality rate that is rising rather than falling.⁹ The Texas Maternal Mortality and Morbidity Task Force found that between 2012 and 2015 drug overdose was the leading cause of maternal death in the period from delivery to 365 days postpartum, and it has increased dramatically since 2010.^10,11

In addition, maternal mortality reviews in several states have identified substance use as a major risk factor for pregnancy-associated deaths.^12,13 In Texas between 2012 and 2015, opioids were found in 58% of maternal drug overdoses.¹⁰ In 2007, 22.8% of women who were enrolled in Medicaid programs in 46 states filled an opioid prescription during pregnancy.¹⁴ Additionally, the rising prevalence of opioid use in pregnancy has led to a sharp increase in neonatal abstinence syndrome (NAS), rising from 1.5 cases per 1000 hospital births in 1999 to 6.0 per 1000 hospital births in 2013.¹⁵ Unsurprisingly, states with the highest rates of opioid prescribing also have the highest rates of NAS.¹⁶

Methadone combined with counseling and behavioral therapy has been the standard of care for the treatment of OUD in pregnancy since the 1970s. Methadone treatment prevents opioid withdrawal symptoms and increases adherence to prenatal care.¹⁷ One of the largest methadone treatment clinics in the San Antonio, TX, area is the Center for Health Care Services (CHCS). University Health System in San Antonio (UHS) has established a clinic called The Mommies Program, where mothers addicted to opioids can receive prenatal care by a dedicated physician, registered nurse, and a certified nurse midwife, who work in collaboration with the CHCS methadone clinic. Pregnant patients with OUD in pregnancy are concurrently enrolled in the Mommies Program and receive prenatal care through UHS and methadone treatment and counseling through CHCS. The continuity effort aims to increase prenatal care rates and adherence to methadone treatment.

Once mothers are off illicit opioids and on methadone, it is essential to discuss breastfeeding with them, as many mothers addicted to illicit opioids may have been told that they should not be breastfeeding. However, breastfeeding should be encouraged in women who are stable on methadone if they are not using illicit drugs and do not have other contraindications, regardless of maternal methadone dose, since the transfer of methadone into breast milk is minimal.^18-20 Breastfeeding is beneficial in women taking methadone and has been associated with decreased severity of NAS symptoms, decreased need for pharmacotherapy, and a shorter hospital stay for the baby.²¹ In addition, breastfeeding contributes to the development of an attachment between mother and infant, while also providing the infant with natural immunity. Women should be counseled about the need to stop breastfeeding in the event of a relapse.²²

Finally, the postpartum period represents a time of increased stressors, such as loss of sleep, child protective services involvement, and frustration with constant demands from new baby. For mothers with addiction, this is an especially sensitive time, as the stressors may be exacerbated by their new sobriety and a sudden end to the motivation they experienced from pregnancy.²³ Therefore, early and frequent postpartum care with methadone dose evaluation is essential in order to decrease drug relapse and screen for postpartum depression in detail, since patients with a history of drug use are at increased risk of postpartum depression.

In 2017 medical students at UT Health Long School of Medicine in San Antonio created a project to educate women about OUD in pregnancy and provide motivational incentives for sustained abstinence; this project has continued each year since. Students provide education about methadone treatment and the dangers of using illicit opioids during and after pregnancy. Students especially focus on educating patients on the key problem areas in the literature, such as overdose, NAS, breastfeeding, postpartum substance use, and postpartum depression.

Methods

From October 2018 to February 2020, a total of 15 medical students volunteered between 1 and 20 times at the Mommies Program clinic, which was held once or twice per week from 8 am to 12 pm. Prior to attending clinic, a fourth-year medical student oriented that year’s group of first-, second-, and third-year medical students who volunteered to attend the clinic. The orientation introduced students to the Mommies Program and instructed them on how and why methadone is prescribed and distributed. Students were also taught how to begin and proceed through each patient encounter, and were given a standard handout to review with patients. This handout made it possible for students of every level to attend the Mommies Program and ensured that the education was standardized at every session (Figure 1).

The only inclusion criteria for participating in the educational intervention and survey was participants had to be 18 years of age or older and enrolled in the Mommies Program. Patients who met the inclusion criteria and agreed to participate completed a pre-survey administered by the students during the patient’s initial prenatal visit (Figure 2). This survey collected baseline information about the patient’s history with opioid use and their current knowledge of methadone treatment, NAS, legal aspects of drug use disclosure, and drug testing prior to the education portion of the encounter. After the pre-survey was administered, students spent 30 minutes reviewing the correct answers of the survey with the patients by utilizing the standardized handout to help patients understand details of methadone and opioid use in pregnancy (Figure 1). The post-survey was administered by a student once patients entered the third trimester to assess whether the education session increased patients’ knowledge of these topics.

At the time patients completed the post-survey, they received a Baby Bag as well as education regarding each item in the bag. The aim of distributing Baby Bags was to relieve some possible postnatal stressors and educate the patients about infant care. Items included in the bag were diapers, wipes, bottles, clothes, and swaddles. Prenatal vitamins were added in January 2020, as many patients struggle to afford vitamins if they are not currently covered by Medicaid or have other barriers. The Baby Bag items were purchased through a Community Service Learning grant through UT Health San Antonio.

Results

Of 68 women enrolled in the Mommies Program during the intervention period, 33 completed the pre-survey and the post-survey (48.5%). Even though all patients enrolled in the program met the inclusion criteria, patients were not included in the educational program for multiple reasons, including refusal to participate, poor clinic follow-up, or lack of students to collect surveys. However, all patients who completed the pre-survey did complete the post-survey. In the pre-survey, only 39% of participants knew it was safe to breastfeed while on methadone. In the post-survey, 97% knew it safe to breastfeed. Nearly half (48%) reported being very motivated to quit opioids before pregnancy, but 85% were very motivated to quit once pregnant. In the pre-survey, 76% incorrectly thought they would be reported to authorities by their health providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so. Also, all participants said learning more about the effects of opiates would increase motivation for sobriety.

Discussion

Questions assessed during the educational surveys revolved around patients’ knowledge of the intricacies, legally and physiologically, of methadone treatment for OUD, as well as beneficial aspects for patients and future child health, such as breastfeeding and motivation to quit and stay sober.

It was clear that there was a lack of knowledge and education about breastfeeding, as only 39% of the participants thought that it was safe to breastfeed while on methadone in the pre-survey; in the post survey, this improved to 97%. Students spent a large portion of the educational time going over the safety of breastfeeding for patients on methadone and the many benefits to mother and baby. Students also reviewed breastfeeding with patients every time patients came in for a visit and debunked any falsehoods about the negatives of breastfeeding while on methadone. This is another testament to the benefits of reinforcement around patient education.

The area of trust between provider and patient is essential in all provider-patient relationships. However, in the area of addiction, a trusting bond is especially important, as patients must feel confident and comfortable to disclose every aspect of their lives so the provider can give the best care. It was clear from our initial data that many patients did not feel this trust or understand the legal aspects regarding the provider-patient relationship in the terms of drug use, as the pre-survey shows 76% of patients originally thought they would be reported to authorities if they told their provider they used illegal drugs during pregnancy. This was an enormous issue in the clinic and something that needed to be addressed because, based on these data, we feared many patients would not be honest about using illegal drugs to supplement their methadone if they believed they would be reported to the authorities or even jailed. The medical student education team continually assured patients that their honesty about illegal drug use during pregnancy would not be revealed to the authorities, and also made it clear to patients that it was essential they were honest about illegal drug use so the optimal care could be provided by the team. These discussions were successful, as the post-survey showed that 100% of patients knew they would not be reported to the authorities if they used illegal drugs during the pregnancy. This showed an increase in knowledge, but also suggested an increase in confidence in the provider-patient relationship by patients, which we speculate allowed for a better patient experience, better patient outcomes, and less emotional stress for the patient and provider.

Last, we wanted to study and address the motivation to quit using drugs and stay sober through learning about the effects of opiates and how this motivation was related to pregnancy. A study by Mitchell et al makes clear that pregnancy is a motivation to seek treatment for drug use and to quit,²⁴ and our survey data support these findings, with 48% of patients motivated to quit before they were pregnant and 85% motivated to quit once they knew they were pregnant. In addition, all patients attested on the pre- and post-survey that learning more about opioids would increase their motivation for sobriety. Therefore, we believe education about the use of opioids and other drugs is a strong motivation towards sobriety and should be further studied in methadone treatment and other drugs as well.

We will continue to focus on sobriety postpartum by using the education in pregnancy as a springboard to further postpartum education, as education seems to be very beneficial to future sobriety. In the future, we believe extending the educational program past pregnancy and discussing opioid use and addiction with patients at multiple follow-up visits will be beneficial to patients’ sobriety.

We faced 2 main challenges in implementing this intervention and survey: patients would often miss multiple appointments during their third trimester or would not attend their postpartum visit if they only had 1 prenatal visit; and many clinic sessions had low student attendance because students often had many other responsibilities in medical school and there were only 15 volunteers over the study time. These challenges decreased our post-survey completion rate. However, there has been improvement in follow-up as the project has continued. The Mommies Program now has a full-time registered nurse, and a larger number of medical student teachers have volunteered to attend the clinic. In the future, we aim to increase awareness of our project and the benefits of participation, expand advertising at our medical school to increase student participation, and increase follow-up education in the postpartum period.

Another future direction is to include local, free doula services, which are offered through Catholic Charities in San Antonio. Doulas provide antepartum, intrapartum, and postpartum services, which we believe will help our patients through advocacy and support for sobriety during this emotional and stressful time.

Conclusion

Counseled participants were receptive to learning about the effects of OUD and methadone on themselves and their newborn. Participants unanimously stated that learning more about OUD increased their motivation for sobriety. It was also clear that the increased motivation to be sober during pregnancy, as compared to before pregnancy, is an opportunity to help these women take steps to get sober. Patients also advanced their breastfeeding knowledge, as we helped debunk falsehoods surrounding breastfeeding while on methadone, and we anticipate this will lead to greater breastfeeding rates for our patients on methadone, although this was not specifically studied. Finally, patients learned about patient-provider confidentiality, which allowed for more open and clear communication with patients so they could be cared for to the greatest degree and trust could remain paramount.

Drug use is a common problem in the health care system, and exposure to patients with addiction is important for medical students in training. We believe that attending the Mommies Program allowed medical students to gain exposure and skills to better help patients with OUD.

Corresponding author: Nicholas Stansbury, MD, Nmstansbury85@gmail.com.

Financial disclosures: None.

From the UT Health Long School of Medicine San Antonio, Texas.

Abstract

Objective: To educate pregnant patients with opioid use disorder (OUD) about the effects of opioids in order to improve understanding and help achieve sustained abstinence.

Methods: The Center for Health Care Services and University Hospital System (UHS) in San Antonio, TX, jointly operate a methadone clinic, the Mommies Program, for pregnant women with OUD. As part of this program, medical students discuss methadone use in pregnancy and the health effects of OUD on mother and child and review resources for sustained peripartum abstinence at prenatal visits with pregnant patients with OUD concurrently enrolled in the program. To evaluate the impact of this education intervention, students assessed patients’ knowledge of methadone effects on mother and baby, state laws concerning heroin and methadone use in pregnancy, and motivation to quit using opioids with pre- and post-intervention surveys.

Results: Of 68 women enrolled in the program, 33 completed both the pre-survey and the post-survey (48.5%). Nearly half (48%) were very motivated to quit before pregnancy, but 85% were very motivated to quit once pregnant. All participants said learning more about the effects of opiates would increase motivation for sobriety. Prior to the educational intervention, 39% of participants knew it was safe to breastfeed on methadone, which improved to 97% in the post-survey, and 76% incorrectly thought they would be reported to authorities by their health care providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so.

Conclusion: Pregnancy and education about opioids increased patients’ motivation to quit. Patients also advanced their breastfeeding knowledge and learned about patient-provider confidentiality. Our greatest challenge was participant follow-up; however, this improved with the help of a full-time Mommies Program nurse. Our future aim is to increase project awareness and extend the educational research.

Keywords: pregnancy; addiction; opioids; OUD; counseling.

In 2012 more than 259 million prescriptions for opioids were written in the United States, which was a 200% increase since 1998.¹ Since the early 2000s, admissions to opioid substance abuse programs and the death rate from opioids have quadrupled.^2-4 Specifically, the rate of heroin use increased more than 300% from 2010 to 2014.⁵ Opioid use in pregnancy has also escalated in recent years, with a 3- to 4-fold increase from 2000 to 2009 and with 4 in 1000 deliveries being complicated by opioid use disorder (OUD) in 2011.^6-8

Between 2000 and 2014, the maternal mortality rate in the United States increased 24%, making it the only industrialized nation with a maternal mortality rate that is rising rather than falling.⁹ The Texas Maternal Mortality and Morbidity Task Force found that between 2012 and 2015 drug overdose was the leading cause of maternal death in the period from delivery to 365 days postpartum, and it has increased dramatically since 2010.^10,11

In addition, maternal mortality reviews in several states have identified substance use as a major risk factor for pregnancy-associated deaths.^12,13 In Texas between 2012 and 2015, opioids were found in 58% of maternal drug overdoses.¹⁰ In 2007, 22.8% of women who were enrolled in Medicaid programs in 46 states filled an opioid prescription during pregnancy.¹⁴ Additionally, the rising prevalence of opioid use in pregnancy has led to a sharp increase in neonatal abstinence syndrome (NAS), rising from 1.5 cases per 1000 hospital births in 1999 to 6.0 per 1000 hospital births in 2013.¹⁵ Unsurprisingly, states with the highest rates of opioid prescribing also have the highest rates of NAS.¹⁶

Methadone combined with counseling and behavioral therapy has been the standard of care for the treatment of OUD in pregnancy since the 1970s. Methadone treatment prevents opioid withdrawal symptoms and increases adherence to prenatal care.¹⁷ One of the largest methadone treatment clinics in the San Antonio, TX, area is the Center for Health Care Services (CHCS). University Health System in San Antonio (UHS) has established a clinic called The Mommies Program, where mothers addicted to opioids can receive prenatal care by a dedicated physician, registered nurse, and a certified nurse midwife, who work in collaboration with the CHCS methadone clinic. Pregnant patients with OUD in pregnancy are concurrently enrolled in the Mommies Program and receive prenatal care through UHS and methadone treatment and counseling through CHCS. The continuity effort aims to increase prenatal care rates and adherence to methadone treatment.

Once mothers are off illicit opioids and on methadone, it is essential to discuss breastfeeding with them, as many mothers addicted to illicit opioids may have been told that they should not be breastfeeding. However, breastfeeding should be encouraged in women who are stable on methadone if they are not using illicit drugs and do not have other contraindications, regardless of maternal methadone dose, since the transfer of methadone into breast milk is minimal.^18-20 Breastfeeding is beneficial in women taking methadone and has been associated with decreased severity of NAS symptoms, decreased need for pharmacotherapy, and a shorter hospital stay for the baby.²¹ In addition, breastfeeding contributes to the development of an attachment between mother and infant, while also providing the infant with natural immunity. Women should be counseled about the need to stop breastfeeding in the event of a relapse.²²

Finally, the postpartum period represents a time of increased stressors, such as loss of sleep, child protective services involvement, and frustration with constant demands from new baby. For mothers with addiction, this is an especially sensitive time, as the stressors may be exacerbated by their new sobriety and a sudden end to the motivation they experienced from pregnancy.²³ Therefore, early and frequent postpartum care with methadone dose evaluation is essential in order to decrease drug relapse and screen for postpartum depression in detail, since patients with a history of drug use are at increased risk of postpartum depression.

In 2017 medical students at UT Health Long School of Medicine in San Antonio created a project to educate women about OUD in pregnancy and provide motivational incentives for sustained abstinence; this project has continued each year since. Students provide education about methadone treatment and the dangers of using illicit opioids during and after pregnancy. Students especially focus on educating patients on the key problem areas in the literature, such as overdose, NAS, breastfeeding, postpartum substance use, and postpartum depression.

Methods

From October 2018 to February 2020, a total of 15 medical students volunteered between 1 and 20 times at the Mommies Program clinic, which was held once or twice per week from 8 am to 12 pm. Prior to attending clinic, a fourth-year medical student oriented that year’s group of first-, second-, and third-year medical students who volunteered to attend the clinic. The orientation introduced students to the Mommies Program and instructed them on how and why methadone is prescribed and distributed. Students were also taught how to begin and proceed through each patient encounter, and were given a standard handout to review with patients. This handout made it possible for students of every level to attend the Mommies Program and ensured that the education was standardized at every session (Figure 1).

The only inclusion criteria for participating in the educational intervention and survey was participants had to be 18 years of age or older and enrolled in the Mommies Program. Patients who met the inclusion criteria and agreed to participate completed a pre-survey administered by the students during the patient’s initial prenatal visit (Figure 2). This survey collected baseline information about the patient’s history with opioid use and their current knowledge of methadone treatment, NAS, legal aspects of drug use disclosure, and drug testing prior to the education portion of the encounter. After the pre-survey was administered, students spent 30 minutes reviewing the correct answers of the survey with the patients by utilizing the standardized handout to help patients understand details of methadone and opioid use in pregnancy (Figure 1). The post-survey was administered by a student once patients entered the third trimester to assess whether the education session increased patients’ knowledge of these topics.

At the time patients completed the post-survey, they received a Baby Bag as well as education regarding each item in the bag. The aim of distributing Baby Bags was to relieve some possible postnatal stressors and educate the patients about infant care. Items included in the bag were diapers, wipes, bottles, clothes, and swaddles. Prenatal vitamins were added in January 2020, as many patients struggle to afford vitamins if they are not currently covered by Medicaid or have other barriers. The Baby Bag items were purchased through a Community Service Learning grant through UT Health San Antonio.

Results

Of 68 women enrolled in the Mommies Program during the intervention period, 33 completed the pre-survey and the post-survey (48.5%). Even though all patients enrolled in the program met the inclusion criteria, patients were not included in the educational program for multiple reasons, including refusal to participate, poor clinic follow-up, or lack of students to collect surveys. However, all patients who completed the pre-survey did complete the post-survey. In the pre-survey, only 39% of participants knew it was safe to breastfeed while on methadone. In the post-survey, 97% knew it safe to breastfeed. Nearly half (48%) reported being very motivated to quit opioids before pregnancy, but 85% were very motivated to quit once pregnant. In the pre-survey, 76% incorrectly thought they would be reported to authorities by their health providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so. Also, all participants said learning more about the effects of opiates would increase motivation for sobriety.

Discussion

Questions assessed during the educational surveys revolved around patients’ knowledge of the intricacies, legally and physiologically, of methadone treatment for OUD, as well as beneficial aspects for patients and future child health, such as breastfeeding and motivation to quit and stay sober.

It was clear that there was a lack of knowledge and education about breastfeeding, as only 39% of the participants thought that it was safe to breastfeed while on methadone in the pre-survey; in the post survey, this improved to 97%. Students spent a large portion of the educational time going over the safety of breastfeeding for patients on methadone and the many benefits to mother and baby. Students also reviewed breastfeeding with patients every time patients came in for a visit and debunked any falsehoods about the negatives of breastfeeding while on methadone. This is another testament to the benefits of reinforcement around patient education.

The area of trust between provider and patient is essential in all provider-patient relationships. However, in the area of addiction, a trusting bond is especially important, as patients must feel confident and comfortable to disclose every aspect of their lives so the provider can give the best care. It was clear from our initial data that many patients did not feel this trust or understand the legal aspects regarding the provider-patient relationship in the terms of drug use, as the pre-survey shows 76% of patients originally thought they would be reported to authorities if they told their provider they used illegal drugs during pregnancy. This was an enormous issue in the clinic and something that needed to be addressed because, based on these data, we feared many patients would not be honest about using illegal drugs to supplement their methadone if they believed they would be reported to the authorities or even jailed. The medical student education team continually assured patients that their honesty about illegal drug use during pregnancy would not be revealed to the authorities, and also made it clear to patients that it was essential they were honest about illegal drug use so the optimal care could be provided by the team. These discussions were successful, as the post-survey showed that 100% of patients knew they would not be reported to the authorities if they used illegal drugs during the pregnancy. This showed an increase in knowledge, but also suggested an increase in confidence in the provider-patient relationship by patients, which we speculate allowed for a better patient experience, better patient outcomes, and less emotional stress for the patient and provider.

Last, we wanted to study and address the motivation to quit using drugs and stay sober through learning about the effects of opiates and how this motivation was related to pregnancy. A study by Mitchell et al makes clear that pregnancy is a motivation to seek treatment for drug use and to quit,²⁴ and our survey data support these findings, with 48% of patients motivated to quit before they were pregnant and 85% motivated to quit once they knew they were pregnant. In addition, all patients attested on the pre- and post-survey that learning more about opioids would increase their motivation for sobriety. Therefore, we believe education about the use of opioids and other drugs is a strong motivation towards sobriety and should be further studied in methadone treatment and other drugs as well.

We will continue to focus on sobriety postpartum by using the education in pregnancy as a springboard to further postpartum education, as education seems to be very beneficial to future sobriety. In the future, we believe extending the educational program past pregnancy and discussing opioid use and addiction with patients at multiple follow-up visits will be beneficial to patients’ sobriety.

We faced 2 main challenges in implementing this intervention and survey: patients would often miss multiple appointments during their third trimester or would not attend their postpartum visit if they only had 1 prenatal visit; and many clinic sessions had low student attendance because students often had many other responsibilities in medical school and there were only 15 volunteers over the study time. These challenges decreased our post-survey completion rate. However, there has been improvement in follow-up as the project has continued. The Mommies Program now has a full-time registered nurse, and a larger number of medical student teachers have volunteered to attend the clinic. In the future, we aim to increase awareness of our project and the benefits of participation, expand advertising at our medical school to increase student participation, and increase follow-up education in the postpartum period.

Another future direction is to include local, free doula services, which are offered through Catholic Charities in San Antonio. Doulas provide antepartum, intrapartum, and postpartum services, which we believe will help our patients through advocacy and support for sobriety during this emotional and stressful time.

Conclusion

Counseled participants were receptive to learning about the effects of OUD and methadone on themselves and their newborn. Participants unanimously stated that learning more about OUD increased their motivation for sobriety. It was also clear that the increased motivation to be sober during pregnancy, as compared to before pregnancy, is an opportunity to help these women take steps to get sober. Patients also advanced their breastfeeding knowledge, as we helped debunk falsehoods surrounding breastfeeding while on methadone, and we anticipate this will lead to greater breastfeeding rates for our patients on methadone, although this was not specifically studied. Finally, patients learned about patient-provider confidentiality, which allowed for more open and clear communication with patients so they could be cared for to the greatest degree and trust could remain paramount.

Drug use is a common problem in the health care system, and exposure to patients with addiction is important for medical students in training. We believe that attending the Mommies Program allowed medical students to gain exposure and skills to better help patients with OUD.

Corresponding author: Nicholas Stansbury, MD, Nmstansbury85@gmail.com.

Financial disclosures: None.

From the UT Health Long School of Medicine San Antonio, Texas.

Abstract

Objective: To educate pregnant patients with opioid use disorder (OUD) about the effects of opioids in order to improve understanding and help achieve sustained abstinence.

Methods: The Center for Health Care Services and University Hospital System (UHS) in San Antonio, TX, jointly operate a methadone clinic, the Mommies Program, for pregnant women with OUD. As part of this program, medical students discuss methadone use in pregnancy and the health effects of OUD on mother and child and review resources for sustained peripartum abstinence at prenatal visits with pregnant patients with OUD concurrently enrolled in the program. To evaluate the impact of this education intervention, students assessed patients’ knowledge of methadone effects on mother and baby, state laws concerning heroin and methadone use in pregnancy, and motivation to quit using opioids with pre- and post-intervention surveys.

Results: Of 68 women enrolled in the program, 33 completed both the pre-survey and the post-survey (48.5%). Nearly half (48%) were very motivated to quit before pregnancy, but 85% were very motivated to quit once pregnant. All participants said learning more about the effects of opiates would increase motivation for sobriety. Prior to the educational intervention, 39% of participants knew it was safe to breastfeed on methadone, which improved to 97% in the post-survey, and 76% incorrectly thought they would be reported to authorities by their health care providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so.

Conclusion: Pregnancy and education about opioids increased patients’ motivation to quit. Patients also advanced their breastfeeding knowledge and learned about patient-provider confidentiality. Our greatest challenge was participant follow-up; however, this improved with the help of a full-time Mommies Program nurse. Our future aim is to increase project awareness and extend the educational research.

Keywords: pregnancy; addiction; opioids; OUD; counseling.

In 2012 more than 259 million prescriptions for opioids were written in the United States, which was a 200% increase since 1998.¹ Since the early 2000s, admissions to opioid substance abuse programs and the death rate from opioids have quadrupled.^2-4 Specifically, the rate of heroin use increased more than 300% from 2010 to 2014.⁵ Opioid use in pregnancy has also escalated in recent years, with a 3- to 4-fold increase from 2000 to 2009 and with 4 in 1000 deliveries being complicated by opioid use disorder (OUD) in 2011.^6-8

Between 2000 and 2014, the maternal mortality rate in the United States increased 24%, making it the only industrialized nation with a maternal mortality rate that is rising rather than falling.⁹ The Texas Maternal Mortality and Morbidity Task Force found that between 2012 and 2015 drug overdose was the leading cause of maternal death in the period from delivery to 365 days postpartum, and it has increased dramatically since 2010.^10,11

In addition, maternal mortality reviews in several states have identified substance use as a major risk factor for pregnancy-associated deaths.^12,13 In Texas between 2012 and 2015, opioids were found in 58% of maternal drug overdoses.¹⁰ In 2007, 22.8% of women who were enrolled in Medicaid programs in 46 states filled an opioid prescription during pregnancy.¹⁴ Additionally, the rising prevalence of opioid use in pregnancy has led to a sharp increase in neonatal abstinence syndrome (NAS), rising from 1.5 cases per 1000 hospital births in 1999 to 6.0 per 1000 hospital births in 2013.¹⁵ Unsurprisingly, states with the highest rates of opioid prescribing also have the highest rates of NAS.¹⁶

Methadone combined with counseling and behavioral therapy has been the standard of care for the treatment of OUD in pregnancy since the 1970s. Methadone treatment prevents opioid withdrawal symptoms and increases adherence to prenatal care.¹⁷ One of the largest methadone treatment clinics in the San Antonio, TX, area is the Center for Health Care Services (CHCS). University Health System in San Antonio (UHS) has established a clinic called The Mommies Program, where mothers addicted to opioids can receive prenatal care by a dedicated physician, registered nurse, and a certified nurse midwife, who work in collaboration with the CHCS methadone clinic. Pregnant patients with OUD in pregnancy are concurrently enrolled in the Mommies Program and receive prenatal care through UHS and methadone treatment and counseling through CHCS. The continuity effort aims to increase prenatal care rates and adherence to methadone treatment.

Once mothers are off illicit opioids and on methadone, it is essential to discuss breastfeeding with them, as many mothers addicted to illicit opioids may have been told that they should not be breastfeeding. However, breastfeeding should be encouraged in women who are stable on methadone if they are not using illicit drugs and do not have other contraindications, regardless of maternal methadone dose, since the transfer of methadone into breast milk is minimal.^18-20 Breastfeeding is beneficial in women taking methadone and has been associated with decreased severity of NAS symptoms, decreased need for pharmacotherapy, and a shorter hospital stay for the baby.²¹ In addition, breastfeeding contributes to the development of an attachment between mother and infant, while also providing the infant with natural immunity. Women should be counseled about the need to stop breastfeeding in the event of a relapse.²²

Finally, the postpartum period represents a time of increased stressors, such as loss of sleep, child protective services involvement, and frustration with constant demands from new baby. For mothers with addiction, this is an especially sensitive time, as the stressors may be exacerbated by their new sobriety and a sudden end to the motivation they experienced from pregnancy.²³ Therefore, early and frequent postpartum care with methadone dose evaluation is essential in order to decrease drug relapse and screen for postpartum depression in detail, since patients with a history of drug use are at increased risk of postpartum depression.

In 2017 medical students at UT Health Long School of Medicine in San Antonio created a project to educate women about OUD in pregnancy and provide motivational incentives for sustained abstinence; this project has continued each year since. Students provide education about methadone treatment and the dangers of using illicit opioids during and after pregnancy. Students especially focus on educating patients on the key problem areas in the literature, such as overdose, NAS, breastfeeding, postpartum substance use, and postpartum depression.

Methods

From October 2018 to February 2020, a total of 15 medical students volunteered between 1 and 20 times at the Mommies Program clinic, which was held once or twice per week from 8 am to 12 pm. Prior to attending clinic, a fourth-year medical student oriented that year’s group of first-, second-, and third-year medical students who volunteered to attend the clinic. The orientation introduced students to the Mommies Program and instructed them on how and why methadone is prescribed and distributed. Students were also taught how to begin and proceed through each patient encounter, and were given a standard handout to review with patients. This handout made it possible for students of every level to attend the Mommies Program and ensured that the education was standardized at every session (Figure 1).

The only inclusion criteria for participating in the educational intervention and survey was participants had to be 18 years of age or older and enrolled in the Mommies Program. Patients who met the inclusion criteria and agreed to participate completed a pre-survey administered by the students during the patient’s initial prenatal visit (Figure 2). This survey collected baseline information about the patient’s history with opioid use and their current knowledge of methadone treatment, NAS, legal aspects of drug use disclosure, and drug testing prior to the education portion of the encounter. After the pre-survey was administered, students spent 30 minutes reviewing the correct answers of the survey with the patients by utilizing the standardized handout to help patients understand details of methadone and opioid use in pregnancy (Figure 1). The post-survey was administered by a student once patients entered the third trimester to assess whether the education session increased patients’ knowledge of these topics.

At the time patients completed the post-survey, they received a Baby Bag as well as education regarding each item in the bag. The aim of distributing Baby Bags was to relieve some possible postnatal stressors and educate the patients about infant care. Items included in the bag were diapers, wipes, bottles, clothes, and swaddles. Prenatal vitamins were added in January 2020, as many patients struggle to afford vitamins if they are not currently covered by Medicaid or have other barriers. The Baby Bag items were purchased through a Community Service Learning grant through UT Health San Antonio.

Results

Of 68 women enrolled in the Mommies Program during the intervention period, 33 completed the pre-survey and the post-survey (48.5%). Even though all patients enrolled in the program met the inclusion criteria, patients were not included in the educational program for multiple reasons, including refusal to participate, poor clinic follow-up, or lack of students to collect surveys. However, all patients who completed the pre-survey did complete the post-survey. In the pre-survey, only 39% of participants knew it was safe to breastfeed while on methadone. In the post-survey, 97% knew it safe to breastfeed. Nearly half (48%) reported being very motivated to quit opioids before pregnancy, but 85% were very motivated to quit once pregnant. In the pre-survey, 76% incorrectly thought they would be reported to authorities by their health providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so. Also, all participants said learning more about the effects of opiates would increase motivation for sobriety.

Discussion

Questions assessed during the educational surveys revolved around patients’ knowledge of the intricacies, legally and physiologically, of methadone treatment for OUD, as well as beneficial aspects for patients and future child health, such as breastfeeding and motivation to quit and stay sober.

It was clear that there was a lack of knowledge and education about breastfeeding, as only 39% of the participants thought that it was safe to breastfeed while on methadone in the pre-survey; in the post survey, this improved to 97%. Students spent a large portion of the educational time going over the safety of breastfeeding for patients on methadone and the many benefits to mother and baby. Students also reviewed breastfeeding with patients every time patients came in for a visit and debunked any falsehoods about the negatives of breastfeeding while on methadone. This is another testament to the benefits of reinforcement around patient education.

The area of trust between provider and patient is essential in all provider-patient relationships. However, in the area of addiction, a trusting bond is especially important, as patients must feel confident and comfortable to disclose every aspect of their lives so the provider can give the best care. It was clear from our initial data that many patients did not feel this trust or understand the legal aspects regarding the provider-patient relationship in the terms of drug use, as the pre-survey shows 76% of patients originally thought they would be reported to authorities if they told their provider they used illegal drugs during pregnancy. This was an enormous issue in the clinic and something that needed to be addressed because, based on these data, we feared many patients would not be honest about using illegal drugs to supplement their methadone if they believed they would be reported to the authorities or even jailed. The medical student education team continually assured patients that their honesty about illegal drug use during pregnancy would not be revealed to the authorities, and also made it clear to patients that it was essential they were honest about illegal drug use so the optimal care could be provided by the team. These discussions were successful, as the post-survey showed that 100% of patients knew they would not be reported to the authorities if they used illegal drugs during the pregnancy. This showed an increase in knowledge, but also suggested an increase in confidence in the provider-patient relationship by patients, which we speculate allowed for a better patient experience, better patient outcomes, and less emotional stress for the patient and provider.

Last, we wanted to study and address the motivation to quit using drugs and stay sober through learning about the effects of opiates and how this motivation was related to pregnancy. A study by Mitchell et al makes clear that pregnancy is a motivation to seek treatment for drug use and to quit,²⁴ and our survey data support these findings, with 48% of patients motivated to quit before they were pregnant and 85% motivated to quit once they knew they were pregnant. In addition, all patients attested on the pre- and post-survey that learning more about opioids would increase their motivation for sobriety. Therefore, we believe education about the use of opioids and other drugs is a strong motivation towards sobriety and should be further studied in methadone treatment and other drugs as well.

We will continue to focus on sobriety postpartum by using the education in pregnancy as a springboard to further postpartum education, as education seems to be very beneficial to future sobriety. In the future, we believe extending the educational program past pregnancy and discussing opioid use and addiction with patients at multiple follow-up visits will be beneficial to patients’ sobriety.

We faced 2 main challenges in implementing this intervention and survey: patients would often miss multiple appointments during their third trimester or would not attend their postpartum visit if they only had 1 prenatal visit; and many clinic sessions had low student attendance because students often had many other responsibilities in medical school and there were only 15 volunteers over the study time. These challenges decreased our post-survey completion rate. However, there has been improvement in follow-up as the project has continued. The Mommies Program now has a full-time registered nurse, and a larger number of medical student teachers have volunteered to attend the clinic. In the future, we aim to increase awareness of our project and the benefits of participation, expand advertising at our medical school to increase student participation, and increase follow-up education in the postpartum period.

Another future direction is to include local, free doula services, which are offered through Catholic Charities in San Antonio. Doulas provide antepartum, intrapartum, and postpartum services, which we believe will help our patients through advocacy and support for sobriety during this emotional and stressful time.

Conclusion

Counseled participants were receptive to learning about the effects of OUD and methadone on themselves and their newborn. Participants unanimously stated that learning more about OUD increased their motivation for sobriety. It was also clear that the increased motivation to be sober during pregnancy, as compared to before pregnancy, is an opportunity to help these women take steps to get sober. Patients also advanced their breastfeeding knowledge, as we helped debunk falsehoods surrounding breastfeeding while on methadone, and we anticipate this will lead to greater breastfeeding rates for our patients on methadone, although this was not specifically studied. Finally, patients learned about patient-provider confidentiality, which allowed for more open and clear communication with patients so they could be cared for to the greatest degree and trust could remain paramount.

Drug use is a common problem in the health care system, and exposure to patients with addiction is important for medical students in training. We believe that attending the Mommies Program allowed medical students to gain exposure and skills to better help patients with OUD.

Corresponding author: Nicholas Stansbury, MD, Nmstansbury85@gmail.com.

Financial disclosures: None.

The “hottest” presentation at the upcoming 2020 San Antonio Breast Cancer Symposium comes from RxPONDER (abstract GS3-00), a major randomized clinical trial assessing use of a recurrence score among women with lymph node–positive, early-stage breast cancer to determine who might safely forgo chemotherapy.

That’s the word from Virginia Kaklamani, MD, from the University of Texas Health Sciences Center San Antonio. Dr. Kaklamani, a professor of medicine in the division of hematology/oncology, is codirector of the meeting that runs online Dec. 8-11.

If the new trial sounds familiar, that’s because it’s a lot like the TAILORx trial, the results of which were first presented in 2018 and have changed practice in women with early-stage disease and no lymph node involvement.

“This is the lymph-node positive TAILORx. It’s extremely important,” Dr. Kaklamani said in an interview, adding that both trials involved women with hormone receptor (HR)–positive, HER2-negative disease.

If the RxPONDER trial shows similar outcomes between women randomized to adjuvant endocrine therapy alone versus endocrine therapy plus chemotherapy, then clinicians “can potentially avoid giving chemotherapy to a large number of women who are currently receiving it,” she explained.

Because women with nodal involvement (one to three positive axillary nodes) are at a higher risk of recurrence, RxPONDER may provide needed insight on the management of these types of breast cancers, Dr. Kaklamani suggested.

Both trials have used the 21-tumor gene expression assay (Oncotype Dx) to determine recurrence-risk status.

Dr. Kaklamani also spotlighted the phase 3 CONTESSA trial (abstract GS4-01) in 600+ patients with locally advanced or metastatic breast cancer that is HR positive and HER2 negative and has been previously treated with a taxane.

The trial features an experimental oral taxane, tesetaxel. The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine (Xeloda) versus the approved dose of capecitabine alone. Presented data will include progression-free survival results, indicating about a 3-month PFS advantage with tesetaxel, which is taken once every 3 weeks.

“Oral drugs are convenient for patients and, despite limitations, they are, all in all, a revolution in cancer treatment,” noted Dr. Kaklamani, adding that they beneficially eliminate the need for time-consuming infusions and related clinic visits as well as drug ports. 

It will be interesting to see what Steven Vogl, MD, a private practitioner in New Yorky, has to say about CONTESSA and the rest of the SABCS.

He is usually a commentator from the meeting floor, whose self-introduction, “Vogl, New York,” is well known to perennial meeting attendees, according to a profile piece published some years ago.

This year the medical oncologist will also serve as the chair of the “View from the Trenches” session, which is devoted to summarizing the meeting’s most important findings for everyday practitioners.

A number of years ago, Dr. Vogl proposed the idea of this where-the-rubber-meets-the-road session to SABCS meeting planners, which they then adopted. This year, Dr. Kaklamani invited Dr. Vogl to run the session and he accepted.

Dr. Vogl is a “really smart guy who is always right on” with his comments and questions, and he will be the first-ever independent, community-based oncologist to chair a meeting session, said Dr. Kaklamani.
 

Other hot topics

Another hot topic featured at the meeting will be the use of CDK4/6 inhibitors in the adjuvant treatment of HR-positive and HER2-negative disease that has a high risk of recurrence, Dr. Kaklamani said. New data from two trials, monarchE and PENELOPE-B, will be presented.

First, there will be an update from the monarchE trial (abstract GS1-01). The first results from this trial were reported in September at the European Society for Medical Oncology Virtual Congress 2020. They showed that adding abemaciclib (Verzenio) to endocrine therapy reduced the risk of early recurrence. The positive outcome represented the first treatment improvement in this high-risk setting in more than 20 years, according to experts.

A similar trial, PENELOPE-B (abstract GS1-02), looks at palbociclib (Ibrance) in a somewhat different population – those patients with high relapse risk after neoadjuvant chemotherapy. “These are even higher risk ER+ patients [than those in monarchE], which is why they received chemotherapy before surgery,” commented Dr. Kaklamani.

In triple-negative disease, there will be overall survival (OS) results from the phase 3 KEYNOTE-355 study (abstract GS3-01) of pembrolizumab (Keytruda) versus placebo (plus chemotherapy for all patients) as first-line therapy for locally recurrent inoperable or metastatic triple-negative breast cancer. “It’s potentially a huge deal,” said Dr. Kaklamani about the OS data, if they are statistically significant.

A meta-analysis (abstract GS4-08) of data on circulating tumor cells (CTCs), which are shed from the primary tumor into the bloodstream, may point to their value as a tool to determine whether or not a breast cancer treatment is effective. “CTCs allow you to assess how a treatment is doing before you do scans, which typically occur 3 months or so later,” explained Dr. Kaklamani.

CTC results can be assessed in 3-4 weeks and allow clinicians to change treatments if CTC volume increases. However, a previous study of CTCs did not show a clinical benefit with the tool among patients treated mainly with chemotherapies. What’s different about the new study, which is from an international group of investigators, is in the treatments patients with metastatic breast cancer received. “This study is from a different era – with targeted therapies,” said Dr. Kaklamani.

In the new study, changes in CTC levels (with a reduction being a good result) between baseline (pretreatment) and follow-up were analyzed to determine whether they were associated with overall survival.
 

COVID sessions

On the meeting’s first day, SABCS will feature a special session on COVID-19 and breast cancer. The meeting organizers sought to separate the wheat from the chaff in this subject, as much has already been written, published, or presented.

“We received a lot of abstracts on COVID that were studies that were poorly done. We tried to tease through them and select the well-researched ones,” acknowledged Dr. Kaklamani.

The organizers included two patient advocates who have had COVID-19, including during treatment for breast cancer, as participants in the meeting session. The session will also feature global perspectives, with presenters from Brazil, Italy, and the Netherlands. 
 

Plenary lectures

The meeting’s two plenary lectures will focus, respectively, on the increasingly used clinical approach of neoadjuvant therapy in breast cancer, and research in the time of a pandemic.

Elizabeth Mittendorf, MD, PhD, a surgical oncologist and director of the Breast lmmuno-Oncology program and co-director of the Breast Cancer Clinical Research Program at the Dana-Farber/Brigham and Women’s Cancer Center, Boston, will present “Local regional management following neoadjuvant therapy: Minding the knowledge gaps.”

Ned Sharpless, MD, director of the National Cancer Institute, will present “Advancing cancer research during challenging times.”

Dr. Kaklamani disclosed recieving consulting fees with Amgen, Eisai, Puma, Celldex, AstraZeneca, and Athenex; receiving fees for non-CME services received directly from commercial interest or their agents from Pfizer, Celgene, Genentech, Genomic Health, Puma, Eisai, and Novartis; and contracted research with Eisai.

This article first appeared on Medscape.com.

The “hottest” presentation at the upcoming 2020 San Antonio Breast Cancer Symposium comes from RxPONDER (abstract GS3-00), a major randomized clinical trial assessing use of a recurrence score among women with lymph node–positive, early-stage breast cancer to determine who might safely forgo chemotherapy.

That’s the word from Virginia Kaklamani, MD, from the University of Texas Health Sciences Center San Antonio. Dr. Kaklamani, a professor of medicine in the division of hematology/oncology, is codirector of the meeting that runs online Dec. 8-11.

If the new trial sounds familiar, that’s because it’s a lot like the TAILORx trial, the results of which were first presented in 2018 and have changed practice in women with early-stage disease and no lymph node involvement.

“This is the lymph-node positive TAILORx. It’s extremely important,” Dr. Kaklamani said in an interview, adding that both trials involved women with hormone receptor (HR)–positive, HER2-negative disease.

If the RxPONDER trial shows similar outcomes between women randomized to adjuvant endocrine therapy alone versus endocrine therapy plus chemotherapy, then clinicians “can potentially avoid giving chemotherapy to a large number of women who are currently receiving it,” she explained.

Because women with nodal involvement (one to three positive axillary nodes) are at a higher risk of recurrence, RxPONDER may provide needed insight on the management of these types of breast cancers, Dr. Kaklamani suggested.

Both trials have used the 21-tumor gene expression assay (Oncotype Dx) to determine recurrence-risk status.

Dr. Kaklamani also spotlighted the phase 3 CONTESSA trial (abstract GS4-01) in 600+ patients with locally advanced or metastatic breast cancer that is HR positive and HER2 negative and has been previously treated with a taxane.

The trial features an experimental oral taxane, tesetaxel. The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine (Xeloda) versus the approved dose of capecitabine alone. Presented data will include progression-free survival results, indicating about a 3-month PFS advantage with tesetaxel, which is taken once every 3 weeks.

“Oral drugs are convenient for patients and, despite limitations, they are, all in all, a revolution in cancer treatment,” noted Dr. Kaklamani, adding that they beneficially eliminate the need for time-consuming infusions and related clinic visits as well as drug ports. 

It will be interesting to see what Steven Vogl, MD, a private practitioner in New Yorky, has to say about CONTESSA and the rest of the SABCS.

He is usually a commentator from the meeting floor, whose self-introduction, “Vogl, New York,” is well known to perennial meeting attendees, according to a profile piece published some years ago.

This year the medical oncologist will also serve as the chair of the “View from the Trenches” session, which is devoted to summarizing the meeting’s most important findings for everyday practitioners.

A number of years ago, Dr. Vogl proposed the idea of this where-the-rubber-meets-the-road session to SABCS meeting planners, which they then adopted. This year, Dr. Kaklamani invited Dr. Vogl to run the session and he accepted.

Dr. Vogl is a “really smart guy who is always right on” with his comments and questions, and he will be the first-ever independent, community-based oncologist to chair a meeting session, said Dr. Kaklamani.
 

Other hot topics

Another hot topic featured at the meeting will be the use of CDK4/6 inhibitors in the adjuvant treatment of HR-positive and HER2-negative disease that has a high risk of recurrence, Dr. Kaklamani said. New data from two trials, monarchE and PENELOPE-B, will be presented.

First, there will be an update from the monarchE trial (abstract GS1-01). The first results from this trial were reported in September at the European Society for Medical Oncology Virtual Congress 2020. They showed that adding abemaciclib (Verzenio) to endocrine therapy reduced the risk of early recurrence. The positive outcome represented the first treatment improvement in this high-risk setting in more than 20 years, according to experts.

A similar trial, PENELOPE-B (abstract GS1-02), looks at palbociclib (Ibrance) in a somewhat different population – those patients with high relapse risk after neoadjuvant chemotherapy. “These are even higher risk ER+ patients [than those in monarchE], which is why they received chemotherapy before surgery,” commented Dr. Kaklamani.

In triple-negative disease, there will be overall survival (OS) results from the phase 3 KEYNOTE-355 study (abstract GS3-01) of pembrolizumab (Keytruda) versus placebo (plus chemotherapy for all patients) as first-line therapy for locally recurrent inoperable or metastatic triple-negative breast cancer. “It’s potentially a huge deal,” said Dr. Kaklamani about the OS data, if they are statistically significant.

A meta-analysis (abstract GS4-08) of data on circulating tumor cells (CTCs), which are shed from the primary tumor into the bloodstream, may point to their value as a tool to determine whether or not a breast cancer treatment is effective. “CTCs allow you to assess how a treatment is doing before you do scans, which typically occur 3 months or so later,” explained Dr. Kaklamani.

CTC results can be assessed in 3-4 weeks and allow clinicians to change treatments if CTC volume increases. However, a previous study of CTCs did not show a clinical benefit with the tool among patients treated mainly with chemotherapies. What’s different about the new study, which is from an international group of investigators, is in the treatments patients with metastatic breast cancer received. “This study is from a different era – with targeted therapies,” said Dr. Kaklamani.

In the new study, changes in CTC levels (with a reduction being a good result) between baseline (pretreatment) and follow-up were analyzed to determine whether they were associated with overall survival.
 

COVID sessions

On the meeting’s first day, SABCS will feature a special session on COVID-19 and breast cancer. The meeting organizers sought to separate the wheat from the chaff in this subject, as much has already been written, published, or presented.

“We received a lot of abstracts on COVID that were studies that were poorly done. We tried to tease through them and select the well-researched ones,” acknowledged Dr. Kaklamani.

The organizers included two patient advocates who have had COVID-19, including during treatment for breast cancer, as participants in the meeting session. The session will also feature global perspectives, with presenters from Brazil, Italy, and the Netherlands. 
 

Plenary lectures

The meeting’s two plenary lectures will focus, respectively, on the increasingly used clinical approach of neoadjuvant therapy in breast cancer, and research in the time of a pandemic.

Elizabeth Mittendorf, MD, PhD, a surgical oncologist and director of the Breast lmmuno-Oncology program and co-director of the Breast Cancer Clinical Research Program at the Dana-Farber/Brigham and Women’s Cancer Center, Boston, will present “Local regional management following neoadjuvant therapy: Minding the knowledge gaps.”

Ned Sharpless, MD, director of the National Cancer Institute, will present “Advancing cancer research during challenging times.”

Dr. Kaklamani disclosed recieving consulting fees with Amgen, Eisai, Puma, Celldex, AstraZeneca, and Athenex; receiving fees for non-CME services received directly from commercial interest or their agents from Pfizer, Celgene, Genentech, Genomic Health, Puma, Eisai, and Novartis; and contracted research with Eisai.

This article first appeared on Medscape.com.

The “hottest” presentation at the upcoming 2020 San Antonio Breast Cancer Symposium comes from RxPONDER (abstract GS3-00), a major randomized clinical trial assessing use of a recurrence score among women with lymph node–positive, early-stage breast cancer to determine who might safely forgo chemotherapy.

That’s the word from Virginia Kaklamani, MD, from the University of Texas Health Sciences Center San Antonio. Dr. Kaklamani, a professor of medicine in the division of hematology/oncology, is codirector of the meeting that runs online Dec. 8-11.

If the new trial sounds familiar, that’s because it’s a lot like the TAILORx trial, the results of which were first presented in 2018 and have changed practice in women with early-stage disease and no lymph node involvement.

“This is the lymph-node positive TAILORx. It’s extremely important,” Dr. Kaklamani said in an interview, adding that both trials involved women with hormone receptor (HR)–positive, HER2-negative disease.

If the RxPONDER trial shows similar outcomes between women randomized to adjuvant endocrine therapy alone versus endocrine therapy plus chemotherapy, then clinicians “can potentially avoid giving chemotherapy to a large number of women who are currently receiving it,” she explained.

Because women with nodal involvement (one to three positive axillary nodes) are at a higher risk of recurrence, RxPONDER may provide needed insight on the management of these types of breast cancers, Dr. Kaklamani suggested.

Both trials have used the 21-tumor gene expression assay (Oncotype Dx) to determine recurrence-risk status.

Dr. Kaklamani also spotlighted the phase 3 CONTESSA trial (abstract GS4-01) in 600+ patients with locally advanced or metastatic breast cancer that is HR positive and HER2 negative and has been previously treated with a taxane.

The trial features an experimental oral taxane, tesetaxel. The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine (Xeloda) versus the approved dose of capecitabine alone. Presented data will include progression-free survival results, indicating about a 3-month PFS advantage with tesetaxel, which is taken once every 3 weeks.

“Oral drugs are convenient for patients and, despite limitations, they are, all in all, a revolution in cancer treatment,” noted Dr. Kaklamani, adding that they beneficially eliminate the need for time-consuming infusions and related clinic visits as well as drug ports. 

It will be interesting to see what Steven Vogl, MD, a private practitioner in New Yorky, has to say about CONTESSA and the rest of the SABCS.

He is usually a commentator from the meeting floor, whose self-introduction, “Vogl, New York,” is well known to perennial meeting attendees, according to a profile piece published some years ago.

This year the medical oncologist will also serve as the chair of the “View from the Trenches” session, which is devoted to summarizing the meeting’s most important findings for everyday practitioners.

A number of years ago, Dr. Vogl proposed the idea of this where-the-rubber-meets-the-road session to SABCS meeting planners, which they then adopted. This year, Dr. Kaklamani invited Dr. Vogl to run the session and he accepted.

Dr. Vogl is a “really smart guy who is always right on” with his comments and questions, and he will be the first-ever independent, community-based oncologist to chair a meeting session, said Dr. Kaklamani.
 

Other hot topics

Another hot topic featured at the meeting will be the use of CDK4/6 inhibitors in the adjuvant treatment of HR-positive and HER2-negative disease that has a high risk of recurrence, Dr. Kaklamani said. New data from two trials, monarchE and PENELOPE-B, will be presented.

First, there will be an update from the monarchE trial (abstract GS1-01). The first results from this trial were reported in September at the European Society for Medical Oncology Virtual Congress 2020. They showed that adding abemaciclib (Verzenio) to endocrine therapy reduced the risk of early recurrence. The positive outcome represented the first treatment improvement in this high-risk setting in more than 20 years, according to experts.

A similar trial, PENELOPE-B (abstract GS1-02), looks at palbociclib (Ibrance) in a somewhat different population – those patients with high relapse risk after neoadjuvant chemotherapy. “These are even higher risk ER+ patients [than those in monarchE], which is why they received chemotherapy before surgery,” commented Dr. Kaklamani.

In triple-negative disease, there will be overall survival (OS) results from the phase 3 KEYNOTE-355 study (abstract GS3-01) of pembrolizumab (Keytruda) versus placebo (plus chemotherapy for all patients) as first-line therapy for locally recurrent inoperable or metastatic triple-negative breast cancer. “It’s potentially a huge deal,” said Dr. Kaklamani about the OS data, if they are statistically significant.

A meta-analysis (abstract GS4-08) of data on circulating tumor cells (CTCs), which are shed from the primary tumor into the bloodstream, may point to their value as a tool to determine whether or not a breast cancer treatment is effective. “CTCs allow you to assess how a treatment is doing before you do scans, which typically occur 3 months or so later,” explained Dr. Kaklamani.

CTC results can be assessed in 3-4 weeks and allow clinicians to change treatments if CTC volume increases. However, a previous study of CTCs did not show a clinical benefit with the tool among patients treated mainly with chemotherapies. What’s different about the new study, which is from an international group of investigators, is in the treatments patients with metastatic breast cancer received. “This study is from a different era – with targeted therapies,” said Dr. Kaklamani.

In the new study, changes in CTC levels (with a reduction being a good result) between baseline (pretreatment) and follow-up were analyzed to determine whether they were associated with overall survival.
 

COVID sessions

On the meeting’s first day, SABCS will feature a special session on COVID-19 and breast cancer. The meeting organizers sought to separate the wheat from the chaff in this subject, as much has already been written, published, or presented.

“We received a lot of abstracts on COVID that were studies that were poorly done. We tried to tease through them and select the well-researched ones,” acknowledged Dr. Kaklamani.

The organizers included two patient advocates who have had COVID-19, including during treatment for breast cancer, as participants in the meeting session. The session will also feature global perspectives, with presenters from Brazil, Italy, and the Netherlands. 
 

Plenary lectures

The meeting’s two plenary lectures will focus, respectively, on the increasingly used clinical approach of neoadjuvant therapy in breast cancer, and research in the time of a pandemic.

Elizabeth Mittendorf, MD, PhD, a surgical oncologist and director of the Breast lmmuno-Oncology program and co-director of the Breast Cancer Clinical Research Program at the Dana-Farber/Brigham and Women’s Cancer Center, Boston, will present “Local regional management following neoadjuvant therapy: Minding the knowledge gaps.”

Ned Sharpless, MD, director of the National Cancer Institute, will present “Advancing cancer research during challenging times.”

Dr. Kaklamani disclosed recieving consulting fees with Amgen, Eisai, Puma, Celldex, AstraZeneca, and Athenex; receiving fees for non-CME services received directly from commercial interest or their agents from Pfizer, Celgene, Genentech, Genomic Health, Puma, Eisai, and Novartis; and contracted research with Eisai.

This article first appeared on Medscape.com.

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.