Federal Practitioner

The hospital is altogether the most complex human organization ever devised. Peter Drucker ¹

The ever-changing landscape of today’s increasingly complex health care system depends on implementing multifaceted, team-based methods of care delivery to provide safe, effective patient care.² Critical to establishing and sustaining exceptionally safe, effective patient care is open, transparent communication among members of interprofessional teams with senior leaders.³ However, current evidence shows that poor communication among interprofessional health care teams and leadership is commonplace and a significant contributing factor to inefficiencies, medical errors, and poor outcomes.⁴ One strategy for improving communication is through the implementation of leader rounding for high reliability. The concept of high reliability pertains to organizations that operate in high-risk environments for prolonged periods without serious adverse events or catastrophic failures.⁵ The overarching goal of implementation is to ensure that efficient communication exists among members of the health care team, which is essential for providing safe, quality patient care.

We describe the importance of leader rounding for high reliability as an approach to improving patient safety. Based on a review of the literature, our experiences, and lessons learned, we offer recommendations for how health care organizations on the journey to high reliability can improve patient safety.

Rounding in health care is not new. In fact, rounding has been a strong principal practice globally for more than 2 decades.⁶ During this time, varied rounding approaches have emerged, oftentimes focused on areas of interest, such as patient care, environmental services, facilities management, and discharge planning.^4,7 Variations also might involve the location of the rounds, such as a patient’s bedside, unit hallways, and conference rooms as well as the naming of rounds, such as interdisciplinary/multidisciplinary, teaching, and walkrounds.^7-10

A different type of rounding that is characteristic of high reliability organizations (HROs) is leader rounding for high reliability. The Veterans Health Administration (VHA) formally launched its journey to becoming an enterprise HRO in February 2019, using 3 cohorts. At the Veterans Affairs Bedford Healthcare System (VABHS) in Massachusetts, the journey commenced in 2021 as part of the third cohort. Leader rounding for high reliability is one of VHAs 4 HRO foundational practices for achieving a culture of safety (Figure 1).¹¹

Leader rounding for high reliability includes regularly scheduled, structured visits, with interdisciplinary teams to discuss high reliability, safety, and improvement efforts. The specific aim of these particular rounds is for senior leaders to be visible where teams are located and learn from staff (especially those on the frontlines of care) about day-to-day challenges that may contribute to patient harm.^12,13 Leader rounding for high reliability is also an important approach to improving leadership visibility across the organization, demonstrating a commitment to high reliability, and building trust and relationships with staff through open and honest dialogue. It is also an important approach to increasing leadership understanding of operational, clinical, nonclinical, patient experience issues, and concern related to safety.¹¹ This opportunity enables leaders to provide and receive real-time feedback from staff.^9,11 This experience also gives leaders an opportunity to reinforce the VHA’s 3 pillars, 5 principles, and 7 values related to high reliability (Figure 2)¹⁴ as well as to recognize behaviors that support a culture of safety.¹⁵

In preparation for implementing a leader rounding for high reliability process at the VABHS, we conducted an extensive literature review for peer-reviewed publications published between January 2015 and September 2022 regarding how other organizations implemented leader rounding. This search found a dearth of evidence as it specifically relates to leader rounding for high reliability. This motivated us to create a process for developing and implementing leader rounding for high reliability in pursuit of improving patient safety. With this objective in mind, we created and piloted a process in the fall of 2023. The first 3 months were focused on the medical center director rounding with other members of the executive leadership team to assess the feasibility and acceptability of the process. In December 2023, members of the executive leadership team began conducting leader rounding for high reliability separately. The following steps are based on the lessons we have gleaned from evolving evidence, our experiences, and developing and implementing an approach to leader rounding for high reliability.

ESTABLISH A PROCESS

Leader rounding for high reliability is performed by health care organization executive leadership, directors, managers, and supervisors. When properly conducted, increased levels of teamwork and more effective bidirectional communication take place, resulting in a united team motivated to improve patient safety.^16,17 Important early steps for implementing leader rounding for high reliability include establishing a process and getting leadership buy-in. Purposeful attention to planning is critical as is understanding the organizational factors that might deter success. Establishing a process should consider facilitators and barriers to implementation, which can include high vs low leadership turnover, structured vs unstructured rounding, and time for rounding vs competing demands.^18,19 We have learned that effective planning is important for ensuring that leadership teams are well prepared and ambitious about leader rounding for high reliability.

Leader rounding for high reliability involves brief 10-to-15-minute interactions with interdisciplinary teams, including frontline staff. For health care organizations beginning to implement this approach, having scripts or checklists accessible might be of help. If possible, the rounds should be scheduled in advance. This helps to avoid rounding in areas at their busiest times. When possible, leader rounding for high reliability should occur as planned. Canceling rounds sends the message that leader rounding for high reliability and the valuable interactions they support are a low priority. When conflicts arise, another leader should be sent to participate. Developing a list of questions in advance helps to underscore key messages to be shared as well as reinforce principles, practices, behaviors, and attitudes related to high reliability (Appendix 1).¹¹

Finally, closing the loop is critical to the leader rounding process and to improve bidirectional communication. Closed-loop communication, following up on and/or closing out an area of discussion, not only promotes a shared understanding of information but has been found to improve patient safety.¹⁹ Effective leader rounding for high reliability includes summarizing issues and opportunities, deciding on a date for resolution for open action items, and identifying who is responsible for taking action. Senior leaders are not responsible for resolving all issues. If a team or manager of a work area can solve any issues identified, this should be encouraged and supported so accountability is maintained at the most appropriate level of the organization.

Instrumental to leader rounding for high reliability is establishing a cadence for when leaders will visit work areas.¹⁴ The most critical strategy, especially in times of change, is consistency in rounding.¹¹ At the start of implementation, we decided on a biweekly cadence. Initially leaders visited areas of the organization within their respective reporting structure. Once this was established, leaders periodically round in areas outside their scope of responsibility. This affords leaders the opportunity to observe other areas of the organization. As noted, it is important for leaders to be flexible with the rounding process especially in areas where direct patient care is being provided.

Tracking

Developing a tracking tool also is important for an effective leader rounding process. This tool is used to document issues and concerns identified during the rounding process, assign accountability, track the status of items, and close the loop when completed. One of the most commonly reported hurdles to staff sharing information to promote a culture of safety is the lack of feedback on what actions were taken to address the concern or issue raised with leadership. Closed-loop communication is critical for keeping staff continually engaged in efforts to promote a culture of safety.²⁰ We have found that a tracking tool helps to ensure that closed-loop communication takes place.

Various platforms can be used for tracking items and providing follow-up, including paper worksheets, spreadsheets, databases, or third party software (eg, SharePoint, TruthPoint Rounds, GetWell Rounds). The tracking tool should have a standardized approach for prioritizing issues.

Measuring Impact

Measuring the impact is a critical step to determine the overall effectiveness of leader rounding for high reliability. It can be as simple as requesting candid feedback from frontline staff, supervisors, managers, and service chiefs. For example, 4 months into the implementation process, the VABHS administered a brief staff survey on the overall process, perceived benefits, and challenges experienced (Appendix 2). Potential measures include the counts of leaders rounding, total rounds, rounds cancelled, and staff members actively participating in rounds. Outcomes that can be measured include issues identified, addressed, elevated, and remaining open; number of extended workdays due to rounds; staff staying overtime; and delays in patient care activities.²³ Other measures to consider are the effects of rounding on staff as well as patient/family satisfaction, increase in the number of errors and near-miss events reported per month in a health care organizations’ patient safety reporting system, and increased engagement of staff members in continuous process improvement activities. Since the inception of leader rounding for high reliability, the VABHS has seen a slight increase in the number of events entered in the patient safety reporting system. Other factors that may have contributed to this change, including encouragement of reporting at safety forums, and tiered safety huddles.

DISCUSSION

This initiative involved the development and implementation of a leader rounding for high reliability process at the VABHS with the overarching goal of ensuring efficient communication exists among members of the health care team for delivering safe, quality patient care. The initiative was well received by staff from senior leadership to frontline personnel and promoted significant interest in efforts to improve safety across the health care system.

The pilot phase permitted us to examine the feasibility and acceptability of the process to leadership as well as frontline staff. The insight gained and lessons learned through the implementation process helped us make revisions where needed and develop the tools to ensure success. In the second phase of implementation, which commenced in December 2023, each executive leadership team member began leader rounding for high reliability with their respective department service chiefs. Throughout this phase, feedback will be sought on the overall process, perceived benefits, and challenges experienced to make improvements or changes as needed. We also will continue to monitor the number of events entered in the patient safety reporting system. Future efforts will focus on developing a robust program of evaluation to explore the impact of the program on patient/family satisfaction as well as safety outcomes.

Limitations

Developing and implementing a process for leader rounding for high reliability was undertaken to support the VABHS and VHA journey to high reliability. Other health care organizations and integrated systems might identify different processes for improving patient safety and to support their journey to becoming an HRO.

CONCLUSIONS

The importance of leader rounding for high reliability to improve patient safety cannot be emphasized enough in a time where health care systems have become increasingly complex. Health care is a complex adaptive system that requires effective, bidirectional communication and collaboration among all disciplines. One of the most useful, evidence-based strategies for promoting this communication and collaboration to improve a culture of safety is leader rounding for high reliability.

The hospital is altogether the most complex human organization ever devised. Peter Drucker ¹

The ever-changing landscape of today’s increasingly complex health care system depends on implementing multifaceted, team-based methods of care delivery to provide safe, effective patient care.² Critical to establishing and sustaining exceptionally safe, effective patient care is open, transparent communication among members of interprofessional teams with senior leaders.³ However, current evidence shows that poor communication among interprofessional health care teams and leadership is commonplace and a significant contributing factor to inefficiencies, medical errors, and poor outcomes.⁴ One strategy for improving communication is through the implementation of leader rounding for high reliability. The concept of high reliability pertains to organizations that operate in high-risk environments for prolonged periods without serious adverse events or catastrophic failures.⁵ The overarching goal of implementation is to ensure that efficient communication exists among members of the health care team, which is essential for providing safe, quality patient care.

We describe the importance of leader rounding for high reliability as an approach to improving patient safety. Based on a review of the literature, our experiences, and lessons learned, we offer recommendations for how health care organizations on the journey to high reliability can improve patient safety.

Rounding in health care is not new. In fact, rounding has been a strong principal practice globally for more than 2 decades.⁶ During this time, varied rounding approaches have emerged, oftentimes focused on areas of interest, such as patient care, environmental services, facilities management, and discharge planning.^4,7 Variations also might involve the location of the rounds, such as a patient’s bedside, unit hallways, and conference rooms as well as the naming of rounds, such as interdisciplinary/multidisciplinary, teaching, and walkrounds.^7-10

A different type of rounding that is characteristic of high reliability organizations (HROs) is leader rounding for high reliability. The Veterans Health Administration (VHA) formally launched its journey to becoming an enterprise HRO in February 2019, using 3 cohorts. At the Veterans Affairs Bedford Healthcare System (VABHS) in Massachusetts, the journey commenced in 2021 as part of the third cohort. Leader rounding for high reliability is one of VHAs 4 HRO foundational practices for achieving a culture of safety (Figure 1).¹¹

Leader rounding for high reliability includes regularly scheduled, structured visits, with interdisciplinary teams to discuss high reliability, safety, and improvement efforts. The specific aim of these particular rounds is for senior leaders to be visible where teams are located and learn from staff (especially those on the frontlines of care) about day-to-day challenges that may contribute to patient harm.^12,13 Leader rounding for high reliability is also an important approach to improving leadership visibility across the organization, demonstrating a commitment to high reliability, and building trust and relationships with staff through open and honest dialogue. It is also an important approach to increasing leadership understanding of operational, clinical, nonclinical, patient experience issues, and concern related to safety.¹¹ This opportunity enables leaders to provide and receive real-time feedback from staff.^9,11 This experience also gives leaders an opportunity to reinforce the VHA’s 3 pillars, 5 principles, and 7 values related to high reliability (Figure 2)¹⁴ as well as to recognize behaviors that support a culture of safety.¹⁵

In preparation for implementing a leader rounding for high reliability process at the VABHS, we conducted an extensive literature review for peer-reviewed publications published between January 2015 and September 2022 regarding how other organizations implemented leader rounding. This search found a dearth of evidence as it specifically relates to leader rounding for high reliability. This motivated us to create a process for developing and implementing leader rounding for high reliability in pursuit of improving patient safety. With this objective in mind, we created and piloted a process in the fall of 2023. The first 3 months were focused on the medical center director rounding with other members of the executive leadership team to assess the feasibility and acceptability of the process. In December 2023, members of the executive leadership team began conducting leader rounding for high reliability separately. The following steps are based on the lessons we have gleaned from evolving evidence, our experiences, and developing and implementing an approach to leader rounding for high reliability.

ESTABLISH A PROCESS

Leader rounding for high reliability is performed by health care organization executive leadership, directors, managers, and supervisors. When properly conducted, increased levels of teamwork and more effective bidirectional communication take place, resulting in a united team motivated to improve patient safety.^16,17 Important early steps for implementing leader rounding for high reliability include establishing a process and getting leadership buy-in. Purposeful attention to planning is critical as is understanding the organizational factors that might deter success. Establishing a process should consider facilitators and barriers to implementation, which can include high vs low leadership turnover, structured vs unstructured rounding, and time for rounding vs competing demands.^18,19 We have learned that effective planning is important for ensuring that leadership teams are well prepared and ambitious about leader rounding for high reliability.

Leader rounding for high reliability involves brief 10-to-15-minute interactions with interdisciplinary teams, including frontline staff. For health care organizations beginning to implement this approach, having scripts or checklists accessible might be of help. If possible, the rounds should be scheduled in advance. This helps to avoid rounding in areas at their busiest times. When possible, leader rounding for high reliability should occur as planned. Canceling rounds sends the message that leader rounding for high reliability and the valuable interactions they support are a low priority. When conflicts arise, another leader should be sent to participate. Developing a list of questions in advance helps to underscore key messages to be shared as well as reinforce principles, practices, behaviors, and attitudes related to high reliability (Appendix 1).¹¹

Finally, closing the loop is critical to the leader rounding process and to improve bidirectional communication. Closed-loop communication, following up on and/or closing out an area of discussion, not only promotes a shared understanding of information but has been found to improve patient safety.¹⁹ Effective leader rounding for high reliability includes summarizing issues and opportunities, deciding on a date for resolution for open action items, and identifying who is responsible for taking action. Senior leaders are not responsible for resolving all issues. If a team or manager of a work area can solve any issues identified, this should be encouraged and supported so accountability is maintained at the most appropriate level of the organization.

Instrumental to leader rounding for high reliability is establishing a cadence for when leaders will visit work areas.¹⁴ The most critical strategy, especially in times of change, is consistency in rounding.¹¹ At the start of implementation, we decided on a biweekly cadence. Initially leaders visited areas of the organization within their respective reporting structure. Once this was established, leaders periodically round in areas outside their scope of responsibility. This affords leaders the opportunity to observe other areas of the organization. As noted, it is important for leaders to be flexible with the rounding process especially in areas where direct patient care is being provided.

Tracking

Developing a tracking tool also is important for an effective leader rounding process. This tool is used to document issues and concerns identified during the rounding process, assign accountability, track the status of items, and close the loop when completed. One of the most commonly reported hurdles to staff sharing information to promote a culture of safety is the lack of feedback on what actions were taken to address the concern or issue raised with leadership. Closed-loop communication is critical for keeping staff continually engaged in efforts to promote a culture of safety.²⁰ We have found that a tracking tool helps to ensure that closed-loop communication takes place.

Various platforms can be used for tracking items and providing follow-up, including paper worksheets, spreadsheets, databases, or third party software (eg, SharePoint, TruthPoint Rounds, GetWell Rounds). The tracking tool should have a standardized approach for prioritizing issues.

Measuring Impact

Measuring the impact is a critical step to determine the overall effectiveness of leader rounding for high reliability. It can be as simple as requesting candid feedback from frontline staff, supervisors, managers, and service chiefs. For example, 4 months into the implementation process, the VABHS administered a brief staff survey on the overall process, perceived benefits, and challenges experienced (Appendix 2). Potential measures include the counts of leaders rounding, total rounds, rounds cancelled, and staff members actively participating in rounds. Outcomes that can be measured include issues identified, addressed, elevated, and remaining open; number of extended workdays due to rounds; staff staying overtime; and delays in patient care activities.²³ Other measures to consider are the effects of rounding on staff as well as patient/family satisfaction, increase in the number of errors and near-miss events reported per month in a health care organizations’ patient safety reporting system, and increased engagement of staff members in continuous process improvement activities. Since the inception of leader rounding for high reliability, the VABHS has seen a slight increase in the number of events entered in the patient safety reporting system. Other factors that may have contributed to this change, including encouragement of reporting at safety forums, and tiered safety huddles.

DISCUSSION

This initiative involved the development and implementation of a leader rounding for high reliability process at the VABHS with the overarching goal of ensuring efficient communication exists among members of the health care team for delivering safe, quality patient care. The initiative was well received by staff from senior leadership to frontline personnel and promoted significant interest in efforts to improve safety across the health care system.

The pilot phase permitted us to examine the feasibility and acceptability of the process to leadership as well as frontline staff. The insight gained and lessons learned through the implementation process helped us make revisions where needed and develop the tools to ensure success. In the second phase of implementation, which commenced in December 2023, each executive leadership team member began leader rounding for high reliability with their respective department service chiefs. Throughout this phase, feedback will be sought on the overall process, perceived benefits, and challenges experienced to make improvements or changes as needed. We also will continue to monitor the number of events entered in the patient safety reporting system. Future efforts will focus on developing a robust program of evaluation to explore the impact of the program on patient/family satisfaction as well as safety outcomes.

Limitations

Developing and implementing a process for leader rounding for high reliability was undertaken to support the VABHS and VHA journey to high reliability. Other health care organizations and integrated systems might identify different processes for improving patient safety and to support their journey to becoming an HRO.

CONCLUSIONS

The importance of leader rounding for high reliability to improve patient safety cannot be emphasized enough in a time where health care systems have become increasingly complex. Health care is a complex adaptive system that requires effective, bidirectional communication and collaboration among all disciplines. One of the most useful, evidence-based strategies for promoting this communication and collaboration to improve a culture of safety is leader rounding for high reliability.

The hospital is altogether the most complex human organization ever devised. Peter Drucker ¹

The ever-changing landscape of today’s increasingly complex health care system depends on implementing multifaceted, team-based methods of care delivery to provide safe, effective patient care.² Critical to establishing and sustaining exceptionally safe, effective patient care is open, transparent communication among members of interprofessional teams with senior leaders.³ However, current evidence shows that poor communication among interprofessional health care teams and leadership is commonplace and a significant contributing factor to inefficiencies, medical errors, and poor outcomes.⁴ One strategy for improving communication is through the implementation of leader rounding for high reliability. The concept of high reliability pertains to organizations that operate in high-risk environments for prolonged periods without serious adverse events or catastrophic failures.⁵ The overarching goal of implementation is to ensure that efficient communication exists among members of the health care team, which is essential for providing safe, quality patient care.

We describe the importance of leader rounding for high reliability as an approach to improving patient safety. Based on a review of the literature, our experiences, and lessons learned, we offer recommendations for how health care organizations on the journey to high reliability can improve patient safety.

Rounding in health care is not new. In fact, rounding has been a strong principal practice globally for more than 2 decades.⁶ During this time, varied rounding approaches have emerged, oftentimes focused on areas of interest, such as patient care, environmental services, facilities management, and discharge planning.^4,7 Variations also might involve the location of the rounds, such as a patient’s bedside, unit hallways, and conference rooms as well as the naming of rounds, such as interdisciplinary/multidisciplinary, teaching, and walkrounds.^7-10

A different type of rounding that is characteristic of high reliability organizations (HROs) is leader rounding for high reliability. The Veterans Health Administration (VHA) formally launched its journey to becoming an enterprise HRO in February 2019, using 3 cohorts. At the Veterans Affairs Bedford Healthcare System (VABHS) in Massachusetts, the journey commenced in 2021 as part of the third cohort. Leader rounding for high reliability is one of VHAs 4 HRO foundational practices for achieving a culture of safety (Figure 1).¹¹

Leader rounding for high reliability includes regularly scheduled, structured visits, with interdisciplinary teams to discuss high reliability, safety, and improvement efforts. The specific aim of these particular rounds is for senior leaders to be visible where teams are located and learn from staff (especially those on the frontlines of care) about day-to-day challenges that may contribute to patient harm.^12,13 Leader rounding for high reliability is also an important approach to improving leadership visibility across the organization, demonstrating a commitment to high reliability, and building trust and relationships with staff through open and honest dialogue. It is also an important approach to increasing leadership understanding of operational, clinical, nonclinical, patient experience issues, and concern related to safety.¹¹ This opportunity enables leaders to provide and receive real-time feedback from staff.^9,11 This experience also gives leaders an opportunity to reinforce the VHA’s 3 pillars, 5 principles, and 7 values related to high reliability (Figure 2)¹⁴ as well as to recognize behaviors that support a culture of safety.¹⁵

In preparation for implementing a leader rounding for high reliability process at the VABHS, we conducted an extensive literature review for peer-reviewed publications published between January 2015 and September 2022 regarding how other organizations implemented leader rounding. This search found a dearth of evidence as it specifically relates to leader rounding for high reliability. This motivated us to create a process for developing and implementing leader rounding for high reliability in pursuit of improving patient safety. With this objective in mind, we created and piloted a process in the fall of 2023. The first 3 months were focused on the medical center director rounding with other members of the executive leadership team to assess the feasibility and acceptability of the process. In December 2023, members of the executive leadership team began conducting leader rounding for high reliability separately. The following steps are based on the lessons we have gleaned from evolving evidence, our experiences, and developing and implementing an approach to leader rounding for high reliability.

ESTABLISH A PROCESS

Leader rounding for high reliability is performed by health care organization executive leadership, directors, managers, and supervisors. When properly conducted, increased levels of teamwork and more effective bidirectional communication take place, resulting in a united team motivated to improve patient safety.^16,17 Important early steps for implementing leader rounding for high reliability include establishing a process and getting leadership buy-in. Purposeful attention to planning is critical as is understanding the organizational factors that might deter success. Establishing a process should consider facilitators and barriers to implementation, which can include high vs low leadership turnover, structured vs unstructured rounding, and time for rounding vs competing demands.^18,19 We have learned that effective planning is important for ensuring that leadership teams are well prepared and ambitious about leader rounding for high reliability.

Leader rounding for high reliability involves brief 10-to-15-minute interactions with interdisciplinary teams, including frontline staff. For health care organizations beginning to implement this approach, having scripts or checklists accessible might be of help. If possible, the rounds should be scheduled in advance. This helps to avoid rounding in areas at their busiest times. When possible, leader rounding for high reliability should occur as planned. Canceling rounds sends the message that leader rounding for high reliability and the valuable interactions they support are a low priority. When conflicts arise, another leader should be sent to participate. Developing a list of questions in advance helps to underscore key messages to be shared as well as reinforce principles, practices, behaviors, and attitudes related to high reliability (Appendix 1).¹¹

Finally, closing the loop is critical to the leader rounding process and to improve bidirectional communication. Closed-loop communication, following up on and/or closing out an area of discussion, not only promotes a shared understanding of information but has been found to improve patient safety.¹⁹ Effective leader rounding for high reliability includes summarizing issues and opportunities, deciding on a date for resolution for open action items, and identifying who is responsible for taking action. Senior leaders are not responsible for resolving all issues. If a team or manager of a work area can solve any issues identified, this should be encouraged and supported so accountability is maintained at the most appropriate level of the organization.

Instrumental to leader rounding for high reliability is establishing a cadence for when leaders will visit work areas.¹⁴ The most critical strategy, especially in times of change, is consistency in rounding.¹¹ At the start of implementation, we decided on a biweekly cadence. Initially leaders visited areas of the organization within their respective reporting structure. Once this was established, leaders periodically round in areas outside their scope of responsibility. This affords leaders the opportunity to observe other areas of the organization. As noted, it is important for leaders to be flexible with the rounding process especially in areas where direct patient care is being provided.

Tracking

Developing a tracking tool also is important for an effective leader rounding process. This tool is used to document issues and concerns identified during the rounding process, assign accountability, track the status of items, and close the loop when completed. One of the most commonly reported hurdles to staff sharing information to promote a culture of safety is the lack of feedback on what actions were taken to address the concern or issue raised with leadership. Closed-loop communication is critical for keeping staff continually engaged in efforts to promote a culture of safety.²⁰ We have found that a tracking tool helps to ensure that closed-loop communication takes place.

Various platforms can be used for tracking items and providing follow-up, including paper worksheets, spreadsheets, databases, or third party software (eg, SharePoint, TruthPoint Rounds, GetWell Rounds). The tracking tool should have a standardized approach for prioritizing issues.

Measuring Impact

Measuring the impact is a critical step to determine the overall effectiveness of leader rounding for high reliability. It can be as simple as requesting candid feedback from frontline staff, supervisors, managers, and service chiefs. For example, 4 months into the implementation process, the VABHS administered a brief staff survey on the overall process, perceived benefits, and challenges experienced (Appendix 2). Potential measures include the counts of leaders rounding, total rounds, rounds cancelled, and staff members actively participating in rounds. Outcomes that can be measured include issues identified, addressed, elevated, and remaining open; number of extended workdays due to rounds; staff staying overtime; and delays in patient care activities.²³ Other measures to consider are the effects of rounding on staff as well as patient/family satisfaction, increase in the number of errors and near-miss events reported per month in a health care organizations’ patient safety reporting system, and increased engagement of staff members in continuous process improvement activities. Since the inception of leader rounding for high reliability, the VABHS has seen a slight increase in the number of events entered in the patient safety reporting system. Other factors that may have contributed to this change, including encouragement of reporting at safety forums, and tiered safety huddles.

DISCUSSION

This initiative involved the development and implementation of a leader rounding for high reliability process at the VABHS with the overarching goal of ensuring efficient communication exists among members of the health care team for delivering safe, quality patient care. The initiative was well received by staff from senior leadership to frontline personnel and promoted significant interest in efforts to improve safety across the health care system.

The pilot phase permitted us to examine the feasibility and acceptability of the process to leadership as well as frontline staff. The insight gained and lessons learned through the implementation process helped us make revisions where needed and develop the tools to ensure success. In the second phase of implementation, which commenced in December 2023, each executive leadership team member began leader rounding for high reliability with their respective department service chiefs. Throughout this phase, feedback will be sought on the overall process, perceived benefits, and challenges experienced to make improvements or changes as needed. We also will continue to monitor the number of events entered in the patient safety reporting system. Future efforts will focus on developing a robust program of evaluation to explore the impact of the program on patient/family satisfaction as well as safety outcomes.

Limitations

Developing and implementing a process for leader rounding for high reliability was undertaken to support the VABHS and VHA journey to high reliability. Other health care organizations and integrated systems might identify different processes for improving patient safety and to support their journey to becoming an HRO.

CONCLUSIONS

The importance of leader rounding for high reliability to improve patient safety cannot be emphasized enough in a time where health care systems have become increasingly complex. Health care is a complex adaptive system that requires effective, bidirectional communication and collaboration among all disciplines. One of the most useful, evidence-based strategies for promoting this communication and collaboration to improve a culture of safety is leader rounding for high reliability.

The prevalence of diabetes continues to increase despite advances in treatment options. In 2019, according to the Centers for Disease Control and Prevention (CDC), 37.1 million (14.7%) US adults had diabetes. Among adults aged ≥ 65 years, the prevalence is even higher at 29.2%.¹ Research has also estimated that 45% of adults have evidence of prediabetes or diabetes.² According to the Veterans Health Administration, almost 25% of enrolled veterans have diabetes.³

Background

Diabetes is associated with an increased risk of microvascular complications (eg, retinopathy, nephropathy, and neuropathy) and macrovascular complications (eg, atherosclerotic cardiovascular disease) and is one of the most common causes of morbidity and mortality in the US.⁴ In 2017, diabetes was estimated to cost $327 billion in the US, up from $261 billion in 2012.⁵ During this same period, the excess costs per person with diabetes increased from $8417 to $9601.⁵

Type 2 diabetes mellitus (T2DM) and its associated insulin resistance is typically considered a chronic disease with progressive loss of β-cell function. Controlling glycemia, delaying microvascular changes, and preventing macrovascular disease are major management goals. Lifestyle interventions are essential in the management and prevention of T2DM. Medication management for T2DM usually progresses through several medications, ending in insulin therapy.⁶ Within 10 years of diagnosis, almost half of all individuals with T2DM will require insulin to manage their glycemia.⁷

Bariatric surgery and nutrition approaches have been successful in reversing T2DM. Recently, there has been increased interest in nutritional approaches to place T2DM in remission, reverse the disease process, and improve insulin resistance. Contrary to popular belief, before the discovery of insulin in 1921, low-carbohydrate (LC) diets were the most common treatment for T2DM.⁸ With the discovery of insulin and the eventual development of low-fat dietary recommendations, LC diets were no longer favored by most clinicians.⁸ Low-fat diets are, by definition, also high-carbohydrate diets. By the early 1980s, low-fat diets had become the standard of care dietary recommendation, and the goal for clinicians became glycemic maintenance (with increased use of medications) rather than preventing hyperglycemia.⁸

With growing evidence regarding the use of LC diets for T2DM, the US Department of Veterans Affairs (VA) and US Department of Defense (DoD), the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), Diabetes Canada, and Diabetes Australia all include LC diets as a viable option for treating T2DM.^4,9-12 This article will highlight a case using a reduced carbohydrate approach in lifestyle management and provide clinicians with practical guidance in its implementation. We will review the evidence that informs these guidelines, describe a practical approach to nutritional counseling, and review medication management and deprescribing approaches. Finally, barriers to implementation will be explored.

ILLUSTRATIVE CASE

A 64-year-old woman presented to the clinical pharmacist for the management of T2DM after her tenth hospitalization related to hyperglycemia in 10 years. She had previously been managed by primary care clinicians, clinical dietitians, endocrinologists, and certified diabetes care and education specialists. Pertinent history included diabetic ketoacidosis, coronary artery disease, hyperlipidemia, hypertension, obstructive sleep apnea, obesity, metabolic dysfunction-associated steatotic liver disease, and mild nonproliferative diabetic retinopathy with clinically significant macular edema. The patient expressed frustration with poor glycemic control during her many years of insulin therapy and an inability to lose weight due to insulin dose titrations. The patient reported prior education including but not limited to standardized sample menus, consistent carbohydrate intake, calorie reduction, general healthful nutrition, and the “move more, eat less” approach. The patient was unable to titrate insulin dosage and did not experience weight loss despite compliance with these methods.

Her medications included glargine insulin 45 units once daily, aspart insulin 5 units before meals 3 times daily, and metformin 1000 mg twice daily. Her hemoglobin A_1c (HbA_1c) level was 11.8%. A review of prior therapies for T2DM included glyburide 5 mg twice daily, metformin 1000 mg twice daily, 70/30 insulin (up to 340 units/d), glargine insulin (range, 10-140 units/d), regular insulin (range, 30-240 units/d), aspart insulin (range, 15-45 units/d), and U-500 regular insulin (range, 125-390 units/d). She took metoprolol 25 mg extended release daily and hydrochlorothiazide 25 mg daily, but both were discontinued after the most recent hospitalization. A review of HbA_1c readings showed poor glycemic control for > 12 years (range, 10.3% to > 12.3%).

Education for lifestyle modifications, including an LC diet, was presented to the patient to assist with weight loss, improve glycemic control, and reduce insulin resistance. In addition, a glucagon-like peptide-1 agonist (liraglutide) was added to her pharmacotherapy. Continued dietary modifications with LC intake led to consistent reductions in glargine and aspart insulin therapy. The patient remained motivated throughout clinic visits due to improved glycemic control with sustainable dietary modifications, consistently reported feeling better overall, and deprescribed diabetes drug therapies. She remained off her blood pressure medications. After4 months of LC dietary modifications, all insulin therapy was discontinued. She continued with liraglutide 1.8 mg daily and metformin 1000 mg twice daily with an HbA_1c of 6.3%. Two months later, her HbA_1c level was 6.0%. She also lost 8 lb and her body mass index improved from 31 to 29.

 

 

Low-Carbohydrate T2DM DIET MANAGEMENT

LC diets are commonly defined as < 130 g of carbohydrates per day.¹³ Very LC ketogenic (VLCK) diets often contain ≤ 50 g of carbohydrates per day to induce nutritional ketosis.¹³ One of the first randomized controlled trials (RCTs) that compared a VLCK diet (< 30 g of carbohydrates per day) with a low-fat diet for obesity demonstrated greater weight loss at 6 months with the LC diet. In addition, patients with diabetes randomized to the LC group also showed improved insulin sensitivity. Notably, this study was done in a population of veterans enrolled at the VA Philadelphia Health Care System.¹⁴

A 2008 study comparing an LC diet with a calorie-restricted, low-glycemic diet for individuals with T2DM found that the LC diet group experienced a greater reduction in HbA_1c and insulin levels and weight.¹⁵ Comparing these 2 diet groups after 24 weeks, 95% of individuals in the LC group reduced or discontinued T2DM medications vs 62% in the low-glycemic group.¹⁵ Another study of individuals with T2DM compared a VLCK diet with a low-fat diet. After 34 weeks, 55% of individuals in the LC diet group achieved an HbA_1c level below the threshold for diabetes vs 0% in the low-fat diet group.¹⁶ A 2018 study of patients with T2DM investigated the impact of a very LC diet compared with the standard of care.¹⁷ After 1 year, the LC diet group experienced a mean HbA_1c reduction of 1.3%, and 60% of individuals who completed the study achieved an HbA_1c level < 6.5% without T2DM medications (not including metformin). This study also demonstrated that medications were significantly reduced, including 100% discontinuation of sulfonylureas and 94% reduction or elimination of insulin.

A recent study of an LC diet (< 20% energy from carbohydrates) demonstrated reduced HbA_1c levels, weight, and waist circumference vs a control diet after 6 months. The control diet derived 50% to 60% of energy from carbohydrates.¹⁸ This study is typical of other LC interventions, which did not calorie restrict and instead allowed ad libitum intake.^14,15

With mounting evidence, the VA/DoD guidelines on T2DM management included LC diets as dietary options for treating T2DM. The ADA also determined that LC diets had the most evidence in improving glycemia and included LC diets as an option for medical nutrition therapy (Table 1).^10,19

A systematic review and meta-analysis looking at RCTs of LC diets found evidence for remission of T2DM without significant adverse effects (AEs).²⁰ Another recent systematic review and network meta-analysis of 42 RCTs found that the ketogenic diet was superior for a reduction in HbA_1c levels compared with 9 other dietary patterns, including low-fat, Mediterranean, and vegetarian/vegan diets. Overall, ketogenic, Mediterranean, moderate-carbohydrate, and low-glycemic index diets demonstrated improved glycemic control.²¹

Ideally, a comprehensive behavioral program, such as the VA Move! or Whole Health program, should incorporate patient aligned care teams (PACTs), behavioral health clinicians, clinical pharmacists, and dietitians to provide medical-nutrition therapy using LC diets. However, many facilities may not have adequate experience, expertise, or support. We provide practical approaches to provide LC nutrition counseling, medication management, and deprescribing for any primary care clinician applying LC diets for their patients. For simplicity and practicality, we define 3 types of LC dietary patterns: (1) VLCK (< 50 g); (2) LC (50-100 g); and (3) moderate LC (101-150 g).

Nutrition

All nutrition approaches, including LC diets, should be patient centered, individualized, and sensitive to the patient's culture. Typically, many patients have previously been instructed to consume low-fat (and subsequently) high-carbohydrate (> 150 g) meals. Most well-meaning clinicians have provided common-approach diet education from mainstream health organizations in the form of standardized handouts. For example, the Carbohydrate Counting for People with Diabetes patient education handout from the Academy of Nutrition and Dietetics provides a sample menu with 3 meals and 1 snack totaling 195 g of carbohydrates.²² In contrast, an example ADA diet has sample diets with 3 meals and 2 snacks with approximately 20 to 70 g of carbohydrates.²³ In the VA, there are excellent resources to review and standardize handouts that emphasize an LC nutrition approach to T2DM, including ketogenic versions.^24,25 Table 2 shows example meal plans based on different LC patterns—VLCK, LC, and moderate LC.

Starting an LC dietary pattern should maximize nutrient-dense and minimally processed proteins. Clinicians should begin with a baseline nutritional assessment through a 24-hour recall or food diary. After this has been completed, the patient’s baseline diet is assessed, and a gradual carbohydrate reduction plan is discussed. Generally, carbohydrate reduction is recommended at 1 meal per day per week. High-carbohydrate meals and snacks are restructured to favor satiating, minimally processed, high-protein food sources. Individual food preferences are considered and included in the recommended LC plan. For example, LC diets can be formulated for vegetarians and vegans as well as those who prefer meat and seafood. Prioritizing satiating and nutrient-dense foods can help increase the probability of diet acceptance and adherence.

A recent study showed that restricting carbohydrates at breakfast reduces 24-hour postprandial hyperglycemia and improves glycemic variability.²⁶ Many patients consume upward of 50 g of carbohydrates at breakfast.²⁷ For example, it is not uncommon for a patient to consume cereal with milk or oatmeal, orange juice, a banana, and toast at breakfast. Instead, the patient is advised to consume any combination of eggs, meat, no-sugar-added Greek yogurt, or berries.

To keep things simple for lunch and dinner, the patient is offered high-quality, minimally processed protein of their choosing with any nonstarchy vegetable. Should a patient desire additional carbohydrates with meals, they may reduce the baseline serving of carbohydrates by 50%. For example, if a patient normally fills 50% of their plate with spaghetti, they may reduce the pasta portion to 25% and add a meatball or increase the amount of vegetables consumed with the meal to satiety.

Snacks may include cheese, eggs, peanut butter, nuts, seeds, berries, no-sugar-added Greek yogurt, or guacamole. Oftentimes, when LC meals are adopted, the desire or need for snacking is diminished due to the satiating effect of high-quality protein sources and nonstarchy vegetables.

Adverse Effects

AEs have been reported with VLCK diets, including headache, diarrhea, constipation, muscle cramps, halitosis, light-headedness, and muscle weakness.²⁸ These AEs may be mitigated with increased fluid intake, sodium intake, and magnesium supplementation.²⁹ Increasing fluids to a minimum of 2 L/d and adding sodium (eg, bouillon supplementation) can minimize AEs.³⁰ Milk of magnesia (5 mL) or slow-release magnesium chloride 200 mEq/d is suggested to reduce muscle cramps.³⁰ There have been no studies looking at sodium intake and worsening hypertension or chronic heart failure in the setting of an LC diet, but fluid and electrolyte intake should be monitored closely, especially in patients with uncontrolled hypertension and heart failure. Other concerns of higher protein on worsening kidney function have generally not been founded.³¹ In some individuals, an LC and higher fat diet may increase low-density lipoprotein cholesterol (LDL-C).³² Therefore a baseline lipid panel is recommended and should be monitored along with HbA_1c levels. An elevated LDL-C response may be managed by increasing protein and reducing saturated fat intake while maintaining the reduced carbohydrate content of the diet.

Medication Management

The adoption of an LC diet can cause a swift and profound reduction in blood sugar.³³ Utilizing PACTs can help prevent adverse drug events by involving clinical pharmacists to provide recommendations and dose reductions as patients adopt an LC diet. Each approach must be individualized to the patient and can depend on several factors, including the number and strength of medications, the degree of carbohydrate reduction, baseline blood glucose, as well as assessing for medical literacy and ability to implement recommendations. Additionally, patients should monitor their blood sugar regularly and communicate with their primary care team (pharmacist, PACT registered nurse, primary care clinician, and registered dietician). Ultimately, the goal when adopting an LC diet while taking antihyperglycemics is safely avoiding hypoglycemia while reducing the number of medications the patient is taking. We summarize a practical approach to medication management that was recently published (Table 3).^33,34

Medications to Reduce or Discontinue

Medications that can cause hypoglycemia should be the first to be reduced or discontinued upon starting an LC diet, including bolus insulin (although a small amount may be needed to correct for high blood sugar), sulfonylureas, and meglitinides. Combination insulin should be stopped and changed to basal insulin to avoid the risk of hypoglycemia (see Table 4 for insulin deprescribing recommendations). The mechanism of action in preventing the breakdown of carbohydrates in the gastrointestinal tract makes the use of α-glucosidase inhibitors superfluous, and they can be discontinued, reducing pill burden and polypharmacy risks. Sodium-glucose transport protein 2 inhibitors (SGLT2i) should be discontinued for patients on VLCK diets due to the risk of euglycemic diabetic ketoacidosis. However, with LC and moderate LC plans, the SGLT2i may be used with caution as long as patients are made aware of ketoacidosis symptoms. To help prevent the risk of hypoglycemia, basal/long-acting insulin can be continued, but at a 50% reduced dose. Patients should closely monitor blood sugar to assess for appropriateness of dose reductions. While thiazolidinediones are not contraindicated, clinicians can consider discontinuation given both their penchant for inducing weight gain and their limited outcomes data.

Medications to Continue

Medications that pose minimal risk for hypoglycemia can be continued, including metformin, dipeptidyl peptidase 4 inhibitors, and glucagon-like peptide-1 agonists. However, even though these may pose a low risk of hypoglycemia, patients should still closely monitor their blood glucose so medications can be deprescribed as soon as safely and reasonably possible.

Other Medications

The improvement in metabolic health with the reduction of carbohydrates can render other classes of medications unnecessary or require adjustment. Patients should be counseled to monitor their blood pressure as significant and rapid improvements can occur. In the event of a systolic blood pressure of 100 to 110 mm Hg or signs of hypotension, down titration or discontinuation of antihypertensives should be initiated. Limited evidence exists on the preferred order of discontinuation but should be informed by other comorbidities, such as coronary artery disease and chronic kidney disease. Given an LC diet’s diuretic effect, tapering and stopping diuretics may be an option. Other medications requiring closer monitoring include lithium (can be affected by fluid and electrolyte shifts), warfarin (may alter vitamin K intake), valproate (which may be reduced), and zonisamide and topiramate (kidney stone risk).

Remission of T2DM with LC Diets

As patients adopt LC diets and medications are deprescribed and glycemia improves, HbA_1c and fasting glucose levels may drop below the diagnostic threshold for T2DM.²⁰ As new evidence emerges surrounding the management of T2DM from a lifestyle perspective, major health care organizations have acknowledged that T2DM is not necessarily an incurable, progressive disease, but rather a disease that can be reversed or put in remission.^35-37 In 2016, the World Health Organization (WHO) global report on diabetes acknowledged that T2DM reversal can be achieved via weight loss and calorie restriction.³⁵

In 2021, a consensus statement from the ADA, the Endocrine Society, the EASD, and Diabetes UK defined T2DM remission as an HbA_1c level < 6.5% for at least 3 months with no T2DM medications.³⁶ Diabetes Australia also published a position statement in 2021 about T2DM remission.³⁷ Like the WHO, Diabetes Australia acknowledged that remission of T2DM is possible following intensive dietary changes or bariatric surgery.³⁷ Before the 2021 consensus statement, some experts argued that excluding metformin from the T2DM medication list may not be warranted since metformin has indications beyond T2DM. In this case, remission of T2DM could be defined as an HbA_1c level < 6.5% for at least 3 months and on metformin or no T2DM medications.⁸  

Emerging Strategies

Emerging strategies, such as continuous glucose monitors (CGMs) and the use of intermittent fasting/time-restricted eating (TRE), can be used with the LC diet to help improve the monitoring and management of T2DM. In the recently published VA/DoD guidelines for T2DM, the work group suggested real-time CGMs for qualified patients with T2DM.⁴ These include patients on daily insulin who are not achieving glycemic control or to reduce the risk for hypoglycemia. CGMs have shown evidence of improved glycemic control and decreased hypoglycemia in those with T2DM.^38,39 It is currently unknown if CGMs improve long-term glycemic control, but they appear promising for managing and reducing medications for those on an LC diet.⁴⁰

TRE can be supplemented with an LC plan that incorporates “eating windows.” Common patterns include 14 hours of fasting and a 10-hour eating window (14F:10E), or 16 hours of fasting and an 8-hour eating window (16F:8E). By eating only in the specified window, patients generally reduce caloric intake and minimize insulin and glucose excursions during the fasting window. No changes need to be made to the macronutrient composition of the diet, and LC approaches can be used with TRE. The mechanism of action is likely multifactorial, targeting hyperinsulinemia and insulin resistance as well as producing a caloric deficit to enable weight loss.⁴¹ Eating windows may improve insulin sensitivity, reduce insulin resistance, and enhance overall glycemic control. The recent VA/DoD guidelines recommended against intermittent fasting due to concerns over the risk of hypoglycemia despite larger weight loss in TRE groups.⁴ Recently, a study using CGMs and TRE demonstrated both improved glycemic control and no hypoglycemic episodes in patients with T2DM on insulin.⁴² Patients who would like to supplement TRE with an LC plan as a strategy for improved glycemic control should work closely with their PACT to help manage their TRE and LC plan and consider a CGM adjunct, especially if on insulin.

Barriers

Managing T2DM often requires comprehensive lifestyle modifications of nutrition, exercise, sleep, stress management, and other psychosocial issues, as well as an interdisciplinary team-based approach.⁴³ The advantage of working within the VA includes a uniform system within a network of care. However, many patients continue to use both federal and private health care. This use of out-of-network care may result in fragmented, potentially disjointed, or even contradictory dietary advice.

The VA PACT, whole health for holistic health, and weight loss interventions such as the MOVE! program provide lifestyle interventions like nutrition, physical activity, and behavior change. However, these well-intentioned approaches may provide alternative and even diverging recommendations, which place additional barriers to effective patient management. In patients who are advised and accept a trial of an LC plan, each member of the team should embrace the self-management decision of the patient and support the plan.²⁹ Any conflicts, questions, or concerns should be communicated directly with the team in an interdisciplinary approach to provide a unified message and counsel.

The long-term effects and sustainability of an LC diet have been questioned in the literature.^44-46 Recently, the use of an app-based coaching plan has demonstrated short- and long-term sustainability on an LC diet.⁴⁷ In just 5 months in a large VA system, 590 patients using a virtual coaching platform and a VLCK diet plan were found to have lower HbA_1c levels, reduced diabetic medication fills, lower body mass index, fewer outpatient visits, and lower prescription drug costs.

A 5-year follow-up found nearly 50% of participants sustained a VLCK diet for T2DM. For patients who participated in the study after 2 years, 72% sustained the VLCK diet in years 2 to 5. Most required nearly 50% fewer medications and in those that started with insulin, half did not require it at 5 years.⁴⁸ Further research, however, is necessary to determine the long-term effects on cardiometabolic markers and health with LC diets. There are no long-term RCTs on outcomes data looking at T2DM morbidity or mortality. While there are prospective cohort studies on LC diets in the general population on mortality, they demonstrate mixed results. These studies may be confounded by heterogeneous definitions of LC diets, diet quality, and other health factors.^49-51

Conclusions

The effective use of LC diets within a PACT with close and intensive lifestyle counseling and a safe approach to medication management and deprescribing can improve glycemic control, reduce the overall need for insulin, reduce medication use, and provide sustained weight loss. Additionally, the use of therapeutic carbohydrate reduction and subsequent medication deprescription may lead to sustained remission of T2DM. The current efficacy and sustainment of therapeutic carbohydrate reduction for patients with T2DM appears promising. Further research on LC diets, emerging strategies, and long-term effects on cardiometabolic risk factors, morbidity, and mortality will continue to inform future practice in our health care system.

Acknowledgments

We thank Cecile Seth who has been instrumental in pushing us forward and the Metabolic Multiplier group who has helped encourage and provide input into this article.

The prevalence of diabetes continues to increase despite advances in treatment options. In 2019, according to the Centers for Disease Control and Prevention (CDC), 37.1 million (14.7%) US adults had diabetes. Among adults aged ≥ 65 years, the prevalence is even higher at 29.2%.¹ Research has also estimated that 45% of adults have evidence of prediabetes or diabetes.² According to the Veterans Health Administration, almost 25% of enrolled veterans have diabetes.³

Background

Diabetes is associated with an increased risk of microvascular complications (eg, retinopathy, nephropathy, and neuropathy) and macrovascular complications (eg, atherosclerotic cardiovascular disease) and is one of the most common causes of morbidity and mortality in the US.⁴ In 2017, diabetes was estimated to cost $327 billion in the US, up from $261 billion in 2012.⁵ During this same period, the excess costs per person with diabetes increased from $8417 to $9601.⁵

Type 2 diabetes mellitus (T2DM) and its associated insulin resistance is typically considered a chronic disease with progressive loss of β-cell function. Controlling glycemia, delaying microvascular changes, and preventing macrovascular disease are major management goals. Lifestyle interventions are essential in the management and prevention of T2DM. Medication management for T2DM usually progresses through several medications, ending in insulin therapy.⁶ Within 10 years of diagnosis, almost half of all individuals with T2DM will require insulin to manage their glycemia.⁷

Bariatric surgery and nutrition approaches have been successful in reversing T2DM. Recently, there has been increased interest in nutritional approaches to place T2DM in remission, reverse the disease process, and improve insulin resistance. Contrary to popular belief, before the discovery of insulin in 1921, low-carbohydrate (LC) diets were the most common treatment for T2DM.⁸ With the discovery of insulin and the eventual development of low-fat dietary recommendations, LC diets were no longer favored by most clinicians.⁸ Low-fat diets are, by definition, also high-carbohydrate diets. By the early 1980s, low-fat diets had become the standard of care dietary recommendation, and the goal for clinicians became glycemic maintenance (with increased use of medications) rather than preventing hyperglycemia.⁸

With growing evidence regarding the use of LC diets for T2DM, the US Department of Veterans Affairs (VA) and US Department of Defense (DoD), the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), Diabetes Canada, and Diabetes Australia all include LC diets as a viable option for treating T2DM.^4,9-12 This article will highlight a case using a reduced carbohydrate approach in lifestyle management and provide clinicians with practical guidance in its implementation. We will review the evidence that informs these guidelines, describe a practical approach to nutritional counseling, and review medication management and deprescribing approaches. Finally, barriers to implementation will be explored.

ILLUSTRATIVE CASE

A 64-year-old woman presented to the clinical pharmacist for the management of T2DM after her tenth hospitalization related to hyperglycemia in 10 years. She had previously been managed by primary care clinicians, clinical dietitians, endocrinologists, and certified diabetes care and education specialists. Pertinent history included diabetic ketoacidosis, coronary artery disease, hyperlipidemia, hypertension, obstructive sleep apnea, obesity, metabolic dysfunction-associated steatotic liver disease, and mild nonproliferative diabetic retinopathy with clinically significant macular edema. The patient expressed frustration with poor glycemic control during her many years of insulin therapy and an inability to lose weight due to insulin dose titrations. The patient reported prior education including but not limited to standardized sample menus, consistent carbohydrate intake, calorie reduction, general healthful nutrition, and the “move more, eat less” approach. The patient was unable to titrate insulin dosage and did not experience weight loss despite compliance with these methods.

Her medications included glargine insulin 45 units once daily, aspart insulin 5 units before meals 3 times daily, and metformin 1000 mg twice daily. Her hemoglobin A_1c (HbA_1c) level was 11.8%. A review of prior therapies for T2DM included glyburide 5 mg twice daily, metformin 1000 mg twice daily, 70/30 insulin (up to 340 units/d), glargine insulin (range, 10-140 units/d), regular insulin (range, 30-240 units/d), aspart insulin (range, 15-45 units/d), and U-500 regular insulin (range, 125-390 units/d). She took metoprolol 25 mg extended release daily and hydrochlorothiazide 25 mg daily, but both were discontinued after the most recent hospitalization. A review of HbA_1c readings showed poor glycemic control for > 12 years (range, 10.3% to > 12.3%).

Education for lifestyle modifications, including an LC diet, was presented to the patient to assist with weight loss, improve glycemic control, and reduce insulin resistance. In addition, a glucagon-like peptide-1 agonist (liraglutide) was added to her pharmacotherapy. Continued dietary modifications with LC intake led to consistent reductions in glargine and aspart insulin therapy. The patient remained motivated throughout clinic visits due to improved glycemic control with sustainable dietary modifications, consistently reported feeling better overall, and deprescribed diabetes drug therapies. She remained off her blood pressure medications. After4 months of LC dietary modifications, all insulin therapy was discontinued. She continued with liraglutide 1.8 mg daily and metformin 1000 mg twice daily with an HbA_1c of 6.3%. Two months later, her HbA_1c level was 6.0%. She also lost 8 lb and her body mass index improved from 31 to 29.

 

 

Low-Carbohydrate T2DM DIET MANAGEMENT

LC diets are commonly defined as < 130 g of carbohydrates per day.¹³ Very LC ketogenic (VLCK) diets often contain ≤ 50 g of carbohydrates per day to induce nutritional ketosis.¹³ One of the first randomized controlled trials (RCTs) that compared a VLCK diet (< 30 g of carbohydrates per day) with a low-fat diet for obesity demonstrated greater weight loss at 6 months with the LC diet. In addition, patients with diabetes randomized to the LC group also showed improved insulin sensitivity. Notably, this study was done in a population of veterans enrolled at the VA Philadelphia Health Care System.¹⁴

A 2008 study comparing an LC diet with a calorie-restricted, low-glycemic diet for individuals with T2DM found that the LC diet group experienced a greater reduction in HbA_1c and insulin levels and weight.¹⁵ Comparing these 2 diet groups after 24 weeks, 95% of individuals in the LC group reduced or discontinued T2DM medications vs 62% in the low-glycemic group.¹⁵ Another study of individuals with T2DM compared a VLCK diet with a low-fat diet. After 34 weeks, 55% of individuals in the LC diet group achieved an HbA_1c level below the threshold for diabetes vs 0% in the low-fat diet group.¹⁶ A 2018 study of patients with T2DM investigated the impact of a very LC diet compared with the standard of care.¹⁷ After 1 year, the LC diet group experienced a mean HbA_1c reduction of 1.3%, and 60% of individuals who completed the study achieved an HbA_1c level < 6.5% without T2DM medications (not including metformin). This study also demonstrated that medications were significantly reduced, including 100% discontinuation of sulfonylureas and 94% reduction or elimination of insulin.

A recent study of an LC diet (< 20% energy from carbohydrates) demonstrated reduced HbA_1c levels, weight, and waist circumference vs a control diet after 6 months. The control diet derived 50% to 60% of energy from carbohydrates.¹⁸ This study is typical of other LC interventions, which did not calorie restrict and instead allowed ad libitum intake.^14,15

With mounting evidence, the VA/DoD guidelines on T2DM management included LC diets as dietary options for treating T2DM. The ADA also determined that LC diets had the most evidence in improving glycemia and included LC diets as an option for medical nutrition therapy (Table 1).^10,19

A systematic review and meta-analysis looking at RCTs of LC diets found evidence for remission of T2DM without significant adverse effects (AEs).²⁰ Another recent systematic review and network meta-analysis of 42 RCTs found that the ketogenic diet was superior for a reduction in HbA_1c levels compared with 9 other dietary patterns, including low-fat, Mediterranean, and vegetarian/vegan diets. Overall, ketogenic, Mediterranean, moderate-carbohydrate, and low-glycemic index diets demonstrated improved glycemic control.²¹

Ideally, a comprehensive behavioral program, such as the VA Move! or Whole Health program, should incorporate patient aligned care teams (PACTs), behavioral health clinicians, clinical pharmacists, and dietitians to provide medical-nutrition therapy using LC diets. However, many facilities may not have adequate experience, expertise, or support. We provide practical approaches to provide LC nutrition counseling, medication management, and deprescribing for any primary care clinician applying LC diets for their patients. For simplicity and practicality, we define 3 types of LC dietary patterns: (1) VLCK (< 50 g); (2) LC (50-100 g); and (3) moderate LC (101-150 g).

Nutrition

All nutrition approaches, including LC diets, should be patient centered, individualized, and sensitive to the patient's culture. Typically, many patients have previously been instructed to consume low-fat (and subsequently) high-carbohydrate (> 150 g) meals. Most well-meaning clinicians have provided common-approach diet education from mainstream health organizations in the form of standardized handouts. For example, the Carbohydrate Counting for People with Diabetes patient education handout from the Academy of Nutrition and Dietetics provides a sample menu with 3 meals and 1 snack totaling 195 g of carbohydrates.²² In contrast, an example ADA diet has sample diets with 3 meals and 2 snacks with approximately 20 to 70 g of carbohydrates.²³ In the VA, there are excellent resources to review and standardize handouts that emphasize an LC nutrition approach to T2DM, including ketogenic versions.^24,25 Table 2 shows example meal plans based on different LC patterns—VLCK, LC, and moderate LC.

Starting an LC dietary pattern should maximize nutrient-dense and minimally processed proteins. Clinicians should begin with a baseline nutritional assessment through a 24-hour recall or food diary. After this has been completed, the patient’s baseline diet is assessed, and a gradual carbohydrate reduction plan is discussed. Generally, carbohydrate reduction is recommended at 1 meal per day per week. High-carbohydrate meals and snacks are restructured to favor satiating, minimally processed, high-protein food sources. Individual food preferences are considered and included in the recommended LC plan. For example, LC diets can be formulated for vegetarians and vegans as well as those who prefer meat and seafood. Prioritizing satiating and nutrient-dense foods can help increase the probability of diet acceptance and adherence.

A recent study showed that restricting carbohydrates at breakfast reduces 24-hour postprandial hyperglycemia and improves glycemic variability.²⁶ Many patients consume upward of 50 g of carbohydrates at breakfast.²⁷ For example, it is not uncommon for a patient to consume cereal with milk or oatmeal, orange juice, a banana, and toast at breakfast. Instead, the patient is advised to consume any combination of eggs, meat, no-sugar-added Greek yogurt, or berries.

To keep things simple for lunch and dinner, the patient is offered high-quality, minimally processed protein of their choosing with any nonstarchy vegetable. Should a patient desire additional carbohydrates with meals, they may reduce the baseline serving of carbohydrates by 50%. For example, if a patient normally fills 50% of their plate with spaghetti, they may reduce the pasta portion to 25% and add a meatball or increase the amount of vegetables consumed with the meal to satiety.

Snacks may include cheese, eggs, peanut butter, nuts, seeds, berries, no-sugar-added Greek yogurt, or guacamole. Oftentimes, when LC meals are adopted, the desire or need for snacking is diminished due to the satiating effect of high-quality protein sources and nonstarchy vegetables.

Adverse Effects

AEs have been reported with VLCK diets, including headache, diarrhea, constipation, muscle cramps, halitosis, light-headedness, and muscle weakness.²⁸ These AEs may be mitigated with increased fluid intake, sodium intake, and magnesium supplementation.²⁹ Increasing fluids to a minimum of 2 L/d and adding sodium (eg, bouillon supplementation) can minimize AEs.³⁰ Milk of magnesia (5 mL) or slow-release magnesium chloride 200 mEq/d is suggested to reduce muscle cramps.³⁰ There have been no studies looking at sodium intake and worsening hypertension or chronic heart failure in the setting of an LC diet, but fluid and electrolyte intake should be monitored closely, especially in patients with uncontrolled hypertension and heart failure. Other concerns of higher protein on worsening kidney function have generally not been founded.³¹ In some individuals, an LC and higher fat diet may increase low-density lipoprotein cholesterol (LDL-C).³² Therefore a baseline lipid panel is recommended and should be monitored along with HbA_1c levels. An elevated LDL-C response may be managed by increasing protein and reducing saturated fat intake while maintaining the reduced carbohydrate content of the diet.

Medication Management

The adoption of an LC diet can cause a swift and profound reduction in blood sugar.³³ Utilizing PACTs can help prevent adverse drug events by involving clinical pharmacists to provide recommendations and dose reductions as patients adopt an LC diet. Each approach must be individualized to the patient and can depend on several factors, including the number and strength of medications, the degree of carbohydrate reduction, baseline blood glucose, as well as assessing for medical literacy and ability to implement recommendations. Additionally, patients should monitor their blood sugar regularly and communicate with their primary care team (pharmacist, PACT registered nurse, primary care clinician, and registered dietician). Ultimately, the goal when adopting an LC diet while taking antihyperglycemics is safely avoiding hypoglycemia while reducing the number of medications the patient is taking. We summarize a practical approach to medication management that was recently published (Table 3).^33,34

Medications to Reduce or Discontinue

Medications that can cause hypoglycemia should be the first to be reduced or discontinued upon starting an LC diet, including bolus insulin (although a small amount may be needed to correct for high blood sugar), sulfonylureas, and meglitinides. Combination insulin should be stopped and changed to basal insulin to avoid the risk of hypoglycemia (see Table 4 for insulin deprescribing recommendations). The mechanism of action in preventing the breakdown of carbohydrates in the gastrointestinal tract makes the use of α-glucosidase inhibitors superfluous, and they can be discontinued, reducing pill burden and polypharmacy risks. Sodium-glucose transport protein 2 inhibitors (SGLT2i) should be discontinued for patients on VLCK diets due to the risk of euglycemic diabetic ketoacidosis. However, with LC and moderate LC plans, the SGLT2i may be used with caution as long as patients are made aware of ketoacidosis symptoms. To help prevent the risk of hypoglycemia, basal/long-acting insulin can be continued, but at a 50% reduced dose. Patients should closely monitor blood sugar to assess for appropriateness of dose reductions. While thiazolidinediones are not contraindicated, clinicians can consider discontinuation given both their penchant for inducing weight gain and their limited outcomes data.

Medications to Continue

Medications that pose minimal risk for hypoglycemia can be continued, including metformin, dipeptidyl peptidase 4 inhibitors, and glucagon-like peptide-1 agonists. However, even though these may pose a low risk of hypoglycemia, patients should still closely monitor their blood glucose so medications can be deprescribed as soon as safely and reasonably possible.

Other Medications

The improvement in metabolic health with the reduction of carbohydrates can render other classes of medications unnecessary or require adjustment. Patients should be counseled to monitor their blood pressure as significant and rapid improvements can occur. In the event of a systolic blood pressure of 100 to 110 mm Hg or signs of hypotension, down titration or discontinuation of antihypertensives should be initiated. Limited evidence exists on the preferred order of discontinuation but should be informed by other comorbidities, such as coronary artery disease and chronic kidney disease. Given an LC diet’s diuretic effect, tapering and stopping diuretics may be an option. Other medications requiring closer monitoring include lithium (can be affected by fluid and electrolyte shifts), warfarin (may alter vitamin K intake), valproate (which may be reduced), and zonisamide and topiramate (kidney stone risk).

Remission of T2DM with LC Diets

As patients adopt LC diets and medications are deprescribed and glycemia improves, HbA_1c and fasting glucose levels may drop below the diagnostic threshold for T2DM.²⁰ As new evidence emerges surrounding the management of T2DM from a lifestyle perspective, major health care organizations have acknowledged that T2DM is not necessarily an incurable, progressive disease, but rather a disease that can be reversed or put in remission.^35-37 In 2016, the World Health Organization (WHO) global report on diabetes acknowledged that T2DM reversal can be achieved via weight loss and calorie restriction.³⁵

In 2021, a consensus statement from the ADA, the Endocrine Society, the EASD, and Diabetes UK defined T2DM remission as an HbA_1c level < 6.5% for at least 3 months with no T2DM medications.³⁶ Diabetes Australia also published a position statement in 2021 about T2DM remission.³⁷ Like the WHO, Diabetes Australia acknowledged that remission of T2DM is possible following intensive dietary changes or bariatric surgery.³⁷ Before the 2021 consensus statement, some experts argued that excluding metformin from the T2DM medication list may not be warranted since metformin has indications beyond T2DM. In this case, remission of T2DM could be defined as an HbA_1c level < 6.5% for at least 3 months and on metformin or no T2DM medications.⁸  

Emerging Strategies

Emerging strategies, such as continuous glucose monitors (CGMs) and the use of intermittent fasting/time-restricted eating (TRE), can be used with the LC diet to help improve the monitoring and management of T2DM. In the recently published VA/DoD guidelines for T2DM, the work group suggested real-time CGMs for qualified patients with T2DM.⁴ These include patients on daily insulin who are not achieving glycemic control or to reduce the risk for hypoglycemia. CGMs have shown evidence of improved glycemic control and decreased hypoglycemia in those with T2DM.^38,39 It is currently unknown if CGMs improve long-term glycemic control, but they appear promising for managing and reducing medications for those on an LC diet.⁴⁰

TRE can be supplemented with an LC plan that incorporates “eating windows.” Common patterns include 14 hours of fasting and a 10-hour eating window (14F:10E), or 16 hours of fasting and an 8-hour eating window (16F:8E). By eating only in the specified window, patients generally reduce caloric intake and minimize insulin and glucose excursions during the fasting window. No changes need to be made to the macronutrient composition of the diet, and LC approaches can be used with TRE. The mechanism of action is likely multifactorial, targeting hyperinsulinemia and insulin resistance as well as producing a caloric deficit to enable weight loss.⁴¹ Eating windows may improve insulin sensitivity, reduce insulin resistance, and enhance overall glycemic control. The recent VA/DoD guidelines recommended against intermittent fasting due to concerns over the risk of hypoglycemia despite larger weight loss in TRE groups.⁴ Recently, a study using CGMs and TRE demonstrated both improved glycemic control and no hypoglycemic episodes in patients with T2DM on insulin.⁴² Patients who would like to supplement TRE with an LC plan as a strategy for improved glycemic control should work closely with their PACT to help manage their TRE and LC plan and consider a CGM adjunct, especially if on insulin.

Barriers

Managing T2DM often requires comprehensive lifestyle modifications of nutrition, exercise, sleep, stress management, and other psychosocial issues, as well as an interdisciplinary team-based approach.⁴³ The advantage of working within the VA includes a uniform system within a network of care. However, many patients continue to use both federal and private health care. This use of out-of-network care may result in fragmented, potentially disjointed, or even contradictory dietary advice.

The VA PACT, whole health for holistic health, and weight loss interventions such as the MOVE! program provide lifestyle interventions like nutrition, physical activity, and behavior change. However, these well-intentioned approaches may provide alternative and even diverging recommendations, which place additional barriers to effective patient management. In patients who are advised and accept a trial of an LC plan, each member of the team should embrace the self-management decision of the patient and support the plan.²⁹ Any conflicts, questions, or concerns should be communicated directly with the team in an interdisciplinary approach to provide a unified message and counsel.

The long-term effects and sustainability of an LC diet have been questioned in the literature.^44-46 Recently, the use of an app-based coaching plan has demonstrated short- and long-term sustainability on an LC diet.⁴⁷ In just 5 months in a large VA system, 590 patients using a virtual coaching platform and a VLCK diet plan were found to have lower HbA_1c levels, reduced diabetic medication fills, lower body mass index, fewer outpatient visits, and lower prescription drug costs.

A 5-year follow-up found nearly 50% of participants sustained a VLCK diet for T2DM. For patients who participated in the study after 2 years, 72% sustained the VLCK diet in years 2 to 5. Most required nearly 50% fewer medications and in those that started with insulin, half did not require it at 5 years.⁴⁸ Further research, however, is necessary to determine the long-term effects on cardiometabolic markers and health with LC diets. There are no long-term RCTs on outcomes data looking at T2DM morbidity or mortality. While there are prospective cohort studies on LC diets in the general population on mortality, they demonstrate mixed results. These studies may be confounded by heterogeneous definitions of LC diets, diet quality, and other health factors.^49-51

Conclusions

The effective use of LC diets within a PACT with close and intensive lifestyle counseling and a safe approach to medication management and deprescribing can improve glycemic control, reduce the overall need for insulin, reduce medication use, and provide sustained weight loss. Additionally, the use of therapeutic carbohydrate reduction and subsequent medication deprescription may lead to sustained remission of T2DM. The current efficacy and sustainment of therapeutic carbohydrate reduction for patients with T2DM appears promising. Further research on LC diets, emerging strategies, and long-term effects on cardiometabolic risk factors, morbidity, and mortality will continue to inform future practice in our health care system.

Acknowledgments

We thank Cecile Seth who has been instrumental in pushing us forward and the Metabolic Multiplier group who has helped encourage and provide input into this article.

The prevalence of diabetes continues to increase despite advances in treatment options. In 2019, according to the Centers for Disease Control and Prevention (CDC), 37.1 million (14.7%) US adults had diabetes. Among adults aged ≥ 65 years, the prevalence is even higher at 29.2%.¹ Research has also estimated that 45% of adults have evidence of prediabetes or diabetes.² According to the Veterans Health Administration, almost 25% of enrolled veterans have diabetes.³

Background

Diabetes is associated with an increased risk of microvascular complications (eg, retinopathy, nephropathy, and neuropathy) and macrovascular complications (eg, atherosclerotic cardiovascular disease) and is one of the most common causes of morbidity and mortality in the US.⁴ In 2017, diabetes was estimated to cost $327 billion in the US, up from $261 billion in 2012.⁵ During this same period, the excess costs per person with diabetes increased from $8417 to $9601.⁵

Type 2 diabetes mellitus (T2DM) and its associated insulin resistance is typically considered a chronic disease with progressive loss of β-cell function. Controlling glycemia, delaying microvascular changes, and preventing macrovascular disease are major management goals. Lifestyle interventions are essential in the management and prevention of T2DM. Medication management for T2DM usually progresses through several medications, ending in insulin therapy.⁶ Within 10 years of diagnosis, almost half of all individuals with T2DM will require insulin to manage their glycemia.⁷

Bariatric surgery and nutrition approaches have been successful in reversing T2DM. Recently, there has been increased interest in nutritional approaches to place T2DM in remission, reverse the disease process, and improve insulin resistance. Contrary to popular belief, before the discovery of insulin in 1921, low-carbohydrate (LC) diets were the most common treatment for T2DM.⁸ With the discovery of insulin and the eventual development of low-fat dietary recommendations, LC diets were no longer favored by most clinicians.⁸ Low-fat diets are, by definition, also high-carbohydrate diets. By the early 1980s, low-fat diets had become the standard of care dietary recommendation, and the goal for clinicians became glycemic maintenance (with increased use of medications) rather than preventing hyperglycemia.⁸

With growing evidence regarding the use of LC diets for T2DM, the US Department of Veterans Affairs (VA) and US Department of Defense (DoD), the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), Diabetes Canada, and Diabetes Australia all include LC diets as a viable option for treating T2DM.^4,9-12 This article will highlight a case using a reduced carbohydrate approach in lifestyle management and provide clinicians with practical guidance in its implementation. We will review the evidence that informs these guidelines, describe a practical approach to nutritional counseling, and review medication management and deprescribing approaches. Finally, barriers to implementation will be explored.

ILLUSTRATIVE CASE

A 64-year-old woman presented to the clinical pharmacist for the management of T2DM after her tenth hospitalization related to hyperglycemia in 10 years. She had previously been managed by primary care clinicians, clinical dietitians, endocrinologists, and certified diabetes care and education specialists. Pertinent history included diabetic ketoacidosis, coronary artery disease, hyperlipidemia, hypertension, obstructive sleep apnea, obesity, metabolic dysfunction-associated steatotic liver disease, and mild nonproliferative diabetic retinopathy with clinically significant macular edema. The patient expressed frustration with poor glycemic control during her many years of insulin therapy and an inability to lose weight due to insulin dose titrations. The patient reported prior education including but not limited to standardized sample menus, consistent carbohydrate intake, calorie reduction, general healthful nutrition, and the “move more, eat less” approach. The patient was unable to titrate insulin dosage and did not experience weight loss despite compliance with these methods.

Her medications included glargine insulin 45 units once daily, aspart insulin 5 units before meals 3 times daily, and metformin 1000 mg twice daily. Her hemoglobin A_1c (HbA_1c) level was 11.8%. A review of prior therapies for T2DM included glyburide 5 mg twice daily, metformin 1000 mg twice daily, 70/30 insulin (up to 340 units/d), glargine insulin (range, 10-140 units/d), regular insulin (range, 30-240 units/d), aspart insulin (range, 15-45 units/d), and U-500 regular insulin (range, 125-390 units/d). She took metoprolol 25 mg extended release daily and hydrochlorothiazide 25 mg daily, but both were discontinued after the most recent hospitalization. A review of HbA_1c readings showed poor glycemic control for > 12 years (range, 10.3% to > 12.3%).

Education for lifestyle modifications, including an LC diet, was presented to the patient to assist with weight loss, improve glycemic control, and reduce insulin resistance. In addition, a glucagon-like peptide-1 agonist (liraglutide) was added to her pharmacotherapy. Continued dietary modifications with LC intake led to consistent reductions in glargine and aspart insulin therapy. The patient remained motivated throughout clinic visits due to improved glycemic control with sustainable dietary modifications, consistently reported feeling better overall, and deprescribed diabetes drug therapies. She remained off her blood pressure medications. After4 months of LC dietary modifications, all insulin therapy was discontinued. She continued with liraglutide 1.8 mg daily and metformin 1000 mg twice daily with an HbA_1c of 6.3%. Two months later, her HbA_1c level was 6.0%. She also lost 8 lb and her body mass index improved from 31 to 29.

 

 

Low-Carbohydrate T2DM DIET MANAGEMENT

LC diets are commonly defined as < 130 g of carbohydrates per day.¹³ Very LC ketogenic (VLCK) diets often contain ≤ 50 g of carbohydrates per day to induce nutritional ketosis.¹³ One of the first randomized controlled trials (RCTs) that compared a VLCK diet (< 30 g of carbohydrates per day) with a low-fat diet for obesity demonstrated greater weight loss at 6 months with the LC diet. In addition, patients with diabetes randomized to the LC group also showed improved insulin sensitivity. Notably, this study was done in a population of veterans enrolled at the VA Philadelphia Health Care System.¹⁴

A 2008 study comparing an LC diet with a calorie-restricted, low-glycemic diet for individuals with T2DM found that the LC diet group experienced a greater reduction in HbA_1c and insulin levels and weight.¹⁵ Comparing these 2 diet groups after 24 weeks, 95% of individuals in the LC group reduced or discontinued T2DM medications vs 62% in the low-glycemic group.¹⁵ Another study of individuals with T2DM compared a VLCK diet with a low-fat diet. After 34 weeks, 55% of individuals in the LC diet group achieved an HbA_1c level below the threshold for diabetes vs 0% in the low-fat diet group.¹⁶ A 2018 study of patients with T2DM investigated the impact of a very LC diet compared with the standard of care.¹⁷ After 1 year, the LC diet group experienced a mean HbA_1c reduction of 1.3%, and 60% of individuals who completed the study achieved an HbA_1c level < 6.5% without T2DM medications (not including metformin). This study also demonstrated that medications were significantly reduced, including 100% discontinuation of sulfonylureas and 94% reduction or elimination of insulin.

A recent study of an LC diet (< 20% energy from carbohydrates) demonstrated reduced HbA_1c levels, weight, and waist circumference vs a control diet after 6 months. The control diet derived 50% to 60% of energy from carbohydrates.¹⁸ This study is typical of other LC interventions, which did not calorie restrict and instead allowed ad libitum intake.^14,15

With mounting evidence, the VA/DoD guidelines on T2DM management included LC diets as dietary options for treating T2DM. The ADA also determined that LC diets had the most evidence in improving glycemia and included LC diets as an option for medical nutrition therapy (Table 1).^10,19

A systematic review and meta-analysis looking at RCTs of LC diets found evidence for remission of T2DM without significant adverse effects (AEs).²⁰ Another recent systematic review and network meta-analysis of 42 RCTs found that the ketogenic diet was superior for a reduction in HbA_1c levels compared with 9 other dietary patterns, including low-fat, Mediterranean, and vegetarian/vegan diets. Overall, ketogenic, Mediterranean, moderate-carbohydrate, and low-glycemic index diets demonstrated improved glycemic control.²¹

Ideally, a comprehensive behavioral program, such as the VA Move! or Whole Health program, should incorporate patient aligned care teams (PACTs), behavioral health clinicians, clinical pharmacists, and dietitians to provide medical-nutrition therapy using LC diets. However, many facilities may not have adequate experience, expertise, or support. We provide practical approaches to provide LC nutrition counseling, medication management, and deprescribing for any primary care clinician applying LC diets for their patients. For simplicity and practicality, we define 3 types of LC dietary patterns: (1) VLCK (< 50 g); (2) LC (50-100 g); and (3) moderate LC (101-150 g).

Nutrition

All nutrition approaches, including LC diets, should be patient centered, individualized, and sensitive to the patient's culture. Typically, many patients have previously been instructed to consume low-fat (and subsequently) high-carbohydrate (> 150 g) meals. Most well-meaning clinicians have provided common-approach diet education from mainstream health organizations in the form of standardized handouts. For example, the Carbohydrate Counting for People with Diabetes patient education handout from the Academy of Nutrition and Dietetics provides a sample menu with 3 meals and 1 snack totaling 195 g of carbohydrates.²² In contrast, an example ADA diet has sample diets with 3 meals and 2 snacks with approximately 20 to 70 g of carbohydrates.²³ In the VA, there are excellent resources to review and standardize handouts that emphasize an LC nutrition approach to T2DM, including ketogenic versions.^24,25 Table 2 shows example meal plans based on different LC patterns—VLCK, LC, and moderate LC.

Starting an LC dietary pattern should maximize nutrient-dense and minimally processed proteins. Clinicians should begin with a baseline nutritional assessment through a 24-hour recall or food diary. After this has been completed, the patient’s baseline diet is assessed, and a gradual carbohydrate reduction plan is discussed. Generally, carbohydrate reduction is recommended at 1 meal per day per week. High-carbohydrate meals and snacks are restructured to favor satiating, minimally processed, high-protein food sources. Individual food preferences are considered and included in the recommended LC plan. For example, LC diets can be formulated for vegetarians and vegans as well as those who prefer meat and seafood. Prioritizing satiating and nutrient-dense foods can help increase the probability of diet acceptance and adherence.

A recent study showed that restricting carbohydrates at breakfast reduces 24-hour postprandial hyperglycemia and improves glycemic variability.²⁶ Many patients consume upward of 50 g of carbohydrates at breakfast.²⁷ For example, it is not uncommon for a patient to consume cereal with milk or oatmeal, orange juice, a banana, and toast at breakfast. Instead, the patient is advised to consume any combination of eggs, meat, no-sugar-added Greek yogurt, or berries.

To keep things simple for lunch and dinner, the patient is offered high-quality, minimally processed protein of their choosing with any nonstarchy vegetable. Should a patient desire additional carbohydrates with meals, they may reduce the baseline serving of carbohydrates by 50%. For example, if a patient normally fills 50% of their plate with spaghetti, they may reduce the pasta portion to 25% and add a meatball or increase the amount of vegetables consumed with the meal to satiety.

Snacks may include cheese, eggs, peanut butter, nuts, seeds, berries, no-sugar-added Greek yogurt, or guacamole. Oftentimes, when LC meals are adopted, the desire or need for snacking is diminished due to the satiating effect of high-quality protein sources and nonstarchy vegetables.

Adverse Effects

AEs have been reported with VLCK diets, including headache, diarrhea, constipation, muscle cramps, halitosis, light-headedness, and muscle weakness.²⁸ These AEs may be mitigated with increased fluid intake, sodium intake, and magnesium supplementation.²⁹ Increasing fluids to a minimum of 2 L/d and adding sodium (eg, bouillon supplementation) can minimize AEs.³⁰ Milk of magnesia (5 mL) or slow-release magnesium chloride 200 mEq/d is suggested to reduce muscle cramps.³⁰ There have been no studies looking at sodium intake and worsening hypertension or chronic heart failure in the setting of an LC diet, but fluid and electrolyte intake should be monitored closely, especially in patients with uncontrolled hypertension and heart failure. Other concerns of higher protein on worsening kidney function have generally not been founded.³¹ In some individuals, an LC and higher fat diet may increase low-density lipoprotein cholesterol (LDL-C).³² Therefore a baseline lipid panel is recommended and should be monitored along with HbA_1c levels. An elevated LDL-C response may be managed by increasing protein and reducing saturated fat intake while maintaining the reduced carbohydrate content of the diet.

Medication Management

The adoption of an LC diet can cause a swift and profound reduction in blood sugar.³³ Utilizing PACTs can help prevent adverse drug events by involving clinical pharmacists to provide recommendations and dose reductions as patients adopt an LC diet. Each approach must be individualized to the patient and can depend on several factors, including the number and strength of medications, the degree of carbohydrate reduction, baseline blood glucose, as well as assessing for medical literacy and ability to implement recommendations. Additionally, patients should monitor their blood sugar regularly and communicate with their primary care team (pharmacist, PACT registered nurse, primary care clinician, and registered dietician). Ultimately, the goal when adopting an LC diet while taking antihyperglycemics is safely avoiding hypoglycemia while reducing the number of medications the patient is taking. We summarize a practical approach to medication management that was recently published (Table 3).^33,34

Medications to Reduce or Discontinue

Medications that can cause hypoglycemia should be the first to be reduced or discontinued upon starting an LC diet, including bolus insulin (although a small amount may be needed to correct for high blood sugar), sulfonylureas, and meglitinides. Combination insulin should be stopped and changed to basal insulin to avoid the risk of hypoglycemia (see Table 4 for insulin deprescribing recommendations). The mechanism of action in preventing the breakdown of carbohydrates in the gastrointestinal tract makes the use of α-glucosidase inhibitors superfluous, and they can be discontinued, reducing pill burden and polypharmacy risks. Sodium-glucose transport protein 2 inhibitors (SGLT2i) should be discontinued for patients on VLCK diets due to the risk of euglycemic diabetic ketoacidosis. However, with LC and moderate LC plans, the SGLT2i may be used with caution as long as patients are made aware of ketoacidosis symptoms. To help prevent the risk of hypoglycemia, basal/long-acting insulin can be continued, but at a 50% reduced dose. Patients should closely monitor blood sugar to assess for appropriateness of dose reductions. While thiazolidinediones are not contraindicated, clinicians can consider discontinuation given both their penchant for inducing weight gain and their limited outcomes data.

Medications to Continue

Medications that pose minimal risk for hypoglycemia can be continued, including metformin, dipeptidyl peptidase 4 inhibitors, and glucagon-like peptide-1 agonists. However, even though these may pose a low risk of hypoglycemia, patients should still closely monitor their blood glucose so medications can be deprescribed as soon as safely and reasonably possible.

Other Medications

The improvement in metabolic health with the reduction of carbohydrates can render other classes of medications unnecessary or require adjustment. Patients should be counseled to monitor their blood pressure as significant and rapid improvements can occur. In the event of a systolic blood pressure of 100 to 110 mm Hg or signs of hypotension, down titration or discontinuation of antihypertensives should be initiated. Limited evidence exists on the preferred order of discontinuation but should be informed by other comorbidities, such as coronary artery disease and chronic kidney disease. Given an LC diet’s diuretic effect, tapering and stopping diuretics may be an option. Other medications requiring closer monitoring include lithium (can be affected by fluid and electrolyte shifts), warfarin (may alter vitamin K intake), valproate (which may be reduced), and zonisamide and topiramate (kidney stone risk).

Remission of T2DM with LC Diets

As patients adopt LC diets and medications are deprescribed and glycemia improves, HbA_1c and fasting glucose levels may drop below the diagnostic threshold for T2DM.²⁰ As new evidence emerges surrounding the management of T2DM from a lifestyle perspective, major health care organizations have acknowledged that T2DM is not necessarily an incurable, progressive disease, but rather a disease that can be reversed or put in remission.^35-37 In 2016, the World Health Organization (WHO) global report on diabetes acknowledged that T2DM reversal can be achieved via weight loss and calorie restriction.³⁵

In 2021, a consensus statement from the ADA, the Endocrine Society, the EASD, and Diabetes UK defined T2DM remission as an HbA_1c level < 6.5% for at least 3 months with no T2DM medications.³⁶ Diabetes Australia also published a position statement in 2021 about T2DM remission.³⁷ Like the WHO, Diabetes Australia acknowledged that remission of T2DM is possible following intensive dietary changes or bariatric surgery.³⁷ Before the 2021 consensus statement, some experts argued that excluding metformin from the T2DM medication list may not be warranted since metformin has indications beyond T2DM. In this case, remission of T2DM could be defined as an HbA_1c level < 6.5% for at least 3 months and on metformin or no T2DM medications.⁸  

Emerging Strategies

Emerging strategies, such as continuous glucose monitors (CGMs) and the use of intermittent fasting/time-restricted eating (TRE), can be used with the LC diet to help improve the monitoring and management of T2DM. In the recently published VA/DoD guidelines for T2DM, the work group suggested real-time CGMs for qualified patients with T2DM.⁴ These include patients on daily insulin who are not achieving glycemic control or to reduce the risk for hypoglycemia. CGMs have shown evidence of improved glycemic control and decreased hypoglycemia in those with T2DM.^38,39 It is currently unknown if CGMs improve long-term glycemic control, but they appear promising for managing and reducing medications for those on an LC diet.⁴⁰

TRE can be supplemented with an LC plan that incorporates “eating windows.” Common patterns include 14 hours of fasting and a 10-hour eating window (14F:10E), or 16 hours of fasting and an 8-hour eating window (16F:8E). By eating only in the specified window, patients generally reduce caloric intake and minimize insulin and glucose excursions during the fasting window. No changes need to be made to the macronutrient composition of the diet, and LC approaches can be used with TRE. The mechanism of action is likely multifactorial, targeting hyperinsulinemia and insulin resistance as well as producing a caloric deficit to enable weight loss.⁴¹ Eating windows may improve insulin sensitivity, reduce insulin resistance, and enhance overall glycemic control. The recent VA/DoD guidelines recommended against intermittent fasting due to concerns over the risk of hypoglycemia despite larger weight loss in TRE groups.⁴ Recently, a study using CGMs and TRE demonstrated both improved glycemic control and no hypoglycemic episodes in patients with T2DM on insulin.⁴² Patients who would like to supplement TRE with an LC plan as a strategy for improved glycemic control should work closely with their PACT to help manage their TRE and LC plan and consider a CGM adjunct, especially if on insulin.

Barriers

Managing T2DM often requires comprehensive lifestyle modifications of nutrition, exercise, sleep, stress management, and other psychosocial issues, as well as an interdisciplinary team-based approach.⁴³ The advantage of working within the VA includes a uniform system within a network of care. However, many patients continue to use both federal and private health care. This use of out-of-network care may result in fragmented, potentially disjointed, or even contradictory dietary advice.

The VA PACT, whole health for holistic health, and weight loss interventions such as the MOVE! program provide lifestyle interventions like nutrition, physical activity, and behavior change. However, these well-intentioned approaches may provide alternative and even diverging recommendations, which place additional barriers to effective patient management. In patients who are advised and accept a trial of an LC plan, each member of the team should embrace the self-management decision of the patient and support the plan.²⁹ Any conflicts, questions, or concerns should be communicated directly with the team in an interdisciplinary approach to provide a unified message and counsel.

The long-term effects and sustainability of an LC diet have been questioned in the literature.^44-46 Recently, the use of an app-based coaching plan has demonstrated short- and long-term sustainability on an LC diet.⁴⁷ In just 5 months in a large VA system, 590 patients using a virtual coaching platform and a VLCK diet plan were found to have lower HbA_1c levels, reduced diabetic medication fills, lower body mass index, fewer outpatient visits, and lower prescription drug costs.

A 5-year follow-up found nearly 50% of participants sustained a VLCK diet for T2DM. For patients who participated in the study after 2 years, 72% sustained the VLCK diet in years 2 to 5. Most required nearly 50% fewer medications and in those that started with insulin, half did not require it at 5 years.⁴⁸ Further research, however, is necessary to determine the long-term effects on cardiometabolic markers and health with LC diets. There are no long-term RCTs on outcomes data looking at T2DM morbidity or mortality. While there are prospective cohort studies on LC diets in the general population on mortality, they demonstrate mixed results. These studies may be confounded by heterogeneous definitions of LC diets, diet quality, and other health factors.^49-51

Conclusions

The effective use of LC diets within a PACT with close and intensive lifestyle counseling and a safe approach to medication management and deprescribing can improve glycemic control, reduce the overall need for insulin, reduce medication use, and provide sustained weight loss. Additionally, the use of therapeutic carbohydrate reduction and subsequent medication deprescription may lead to sustained remission of T2DM. The current efficacy and sustainment of therapeutic carbohydrate reduction for patients with T2DM appears promising. Further research on LC diets, emerging strategies, and long-term effects on cardiometabolic risk factors, morbidity, and mortality will continue to inform future practice in our health care system.

Acknowledgments

We thank Cecile Seth who has been instrumental in pushing us forward and the Metabolic Multiplier group who has helped encourage and provide input into this article.

When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.

The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.

Peer Review and Expanded Focus

Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”

In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.

A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.

The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.

From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.

Addressing Post-9/11 Veteran Needs

All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.

Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.

The Last 10 Years and the Next 40

In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.

In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.

More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.

Further reading

To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.

When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.

The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.

Peer Review and Expanded Focus

Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”

In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.

A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.

The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.

From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.

Addressing Post-9/11 Veteran Needs

All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.

Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.

The Last 10 Years and the Next 40

In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.

In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.

More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.

Further reading

To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.

When VA Practitioner published its first issue in January 1984, federal health care was at the cusp of a dramatic transformation. VA Practitioner stepped in to serve “as a forum, as a bulletin, as an easy means of communication with colleagues who share your unique concerns,” founding editor James McCloskey noted in the first issue.

The need for this forum was most acute at the US Department of Veterans Affairs (VA). The agency of about 200,000 employees was decentralizing its management, developing the first electronic health record system, and caring for an aging population of World War II and Vietnam War era veterans with high comorbidity burdens. In the 1980s, the VA was at a nadir and under increasing pressure to change. At that moment of challenge, VA Practitioner offered columns suggesting a way forward and focused on clinical improvements with articles like, “The ghosts of budgets past,” “Psychoenvironment: a therapeutic redesign plan,” and “The VA’s geriatric goals.” Within a few years, the journal had enlisted an editorial advisory board to help guide the journal and provide the first peer review process for articles.

Peer Review and Expanded Focus

Ten years later, tremendous changes were underway for both VA Practitioner and the VA. Ken Kizer, MD, MPH, was named Under Secretary of Health in 1994 and almost immediately started the massive process of reforming and reorganizing the VA’s health care arm: Veterans Health Administration (VHA). The VHA would expand from 2.7 million enrolled veteran patients in 1993 to 8.9 million in 2014. In the process, the VA transformed from an oft derided institution to a major source of research and care that hosted most US physician residents while delivering the “best care anywhere.”

In 1994, VA Practitioner changed its name, becoming Federal Practitioner with an expanded mandate to address the needs of US Department of Defense (DoD) and US Public Health Service (PHS) clinicians working at the Indian Health Service (IHS), Bureau of Prisons, and US Coast Guard. In addition, the journal instituted a double-blind peer review process. Health care reform was clearly on the agenda for the new journal.

A new vision for VHA sought to redistribute resources, decentralize decision making, and make care more patient centered. The VHA began development of the Computerized Patient Record System (CPRS), which was fully implemented by 1999 as one of the earliest electronic health record systems and shared it with the IHS.

The DoD, on the other hand, was in a long-term period of reduction and consolidation. The active-duty service member population dropped from 2.1 million to 1.6 million between 1984 and 1994 and would continue to drop to 1.4 million in 2001, even with the onset of the first Gulf War. The DoD rolled out the Civilian Health and Medical Program of the United States (CHAMPUS), which would later become TRICARE, that reshaped the way the DoD delivered health care for active-duty service members, their families, and retirees.

From the outset, Federal Practitioner sought to play a role in those transformations. For PHS officers stationed across the Centers for Disease Control and Prevention, US Food and Drug Administration, IHS, and Bureau of Prisons, the journal provided a new way to share findings and best practices. With a growing group of dedicated peer reviewers, Federal Practitioner articles became more clinical and more patient centered. Frequent columns gave way to clinical reviews, continuing medical education, and best practice articles.

Addressing Post-9/11 Veteran Needs

All of these changes were well under way on the eve of September 11, 2001. After years of reductions, the size of the military stabilized, but the demographics were shifting in important ways. Women made up a larger proportion of the active-duty population, growing from 5% in 1975 to 10% in 1985 and 14% in 2005. The military was also becoming more diverse, with a growing number of service members indicating Hispanic, Asian, Pacific Islander, and other identities. More importantly, a new set of health care concerns emerged to challenge DoD and VHA clinicians. A growing number of service members and veterans of the Gulf Wars were seeking care for respiratory diseases, cancers, blast injuries, and prosthetics.

Federal Practitioner articles primarily focused on quality improvement but increasingly the journal published original research and case studies. Columns like Common Errors in Internal Medicine and Advances in Geriatrics focused on quality improvement and innovative therapies, respectively. To supplement its 12 regular issues, in 2011 Federal Practitioner began publishing special issues to provide even more depth of coverage in specific disease states, including hematology/oncology (in cooperation with the Association of VA Hematology/Oncology), mental health, neurology, infectious diseases, diabetes, among other topics.

The Last 10 Years and the Next 40

In 2013, the DoD formally reorganized its health care operations under the Defense Health Agency, starting an entirely new process that would dramatically reshape health care delivery for 8 million beneficiaries and 140,000 employees. This started a long process of consolidating separate systems and priorities for each branch into a single approach. Meanwhile, controversies around long wait times for VHA appointments (and veterans who died while waiting) put it under intense scrutiny. Legislation to privatize some or all of health care for veterans were discussed and considered, which finally resulted in the creation of the Veterans Choice Program, which greatly expanded the use of private health care services for covered conditions.

In 2018, Federal Practitioner was accepted by the national Library of Medicine’s PubMed Central, ensuring the widest possible access to journal articles. The journal saw a steady growth in submissions and published a combined 21 regular and special issues that year driven by increased submissions and more original research studies.

More and more through the work of its authors, Federal Practitioner has been in the middle of critical and ongoing federal health care concerns. Federal Practitioner authors have turned to the journal to address issues ranging from the deprescribing of opioid medications to measures taken to decrease the incidence of veteran suicide and the challenges presented by artificial intelligence and telehealth delivery. Whether it was the federal responses to Ebola outbreaks in Africa or the myriad ways that the PHS and VA responded to the COVID-19 pandemic in the US, Federal Practitioner has been at the center of federal health care.

Further reading

To learn more about the past 40 years of federal health care visit mdedge.com/fedprac or doi:10.12788/fp.0453.