PARIS – Women with active atopic dermatitis during pregnancy and their physicians can find reassurance in the Danish national experience over an 18-year period, which showed no increased risk of pregnancy and birth problems other than modestly increased risks of premature rupture of membranes and neonatal staphylococcal septicemia, according to Jacob P. Thyssen, MD, PhD.

Bruce Jancin/MDedge News

At a session of the European Task Force of Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology, he presented a case control study of 10,668 births to Danish women with atopic dermatitis (AD) during 1997-2014. They were matched 1:10 by age, parity, and birth year to mothers without AD.

The risk of premature rupture of membranes was 15% higher in mothers with AD. And while the increased relative risk of neonatal staphylococcal septicemia was more substantial – a 145% increase – this was in fact a rare complication, observed Dr. Thyssen, a dermatologist at the University of Copenhagen.

There was no significant difference between women with or without AD in rates of preeclampsia, prematurity, pregnancy-induced hypertension, placenta previa, placental abruption, neonatal nonstaphylococcal septicemia, or other complications. The two groups had a similar number of visits to physicians and midwives during pregnancy.

Moreover, although the body mass index was similar in women with or without AD, the risk of gestational diabetes in women with the disease was significantly reduced by 21%; their risk of having a large-for-gestational-age baby with a birth weight of 4,500 g or more was also significantly lower than in controls.

Women received less treatment for AD during their pregnancy than they did beforehand. While pregnant, their disease was managed predominantly with topical corticosteroids and UV therapy. There was very little use of superpotent topical steroids, topical calcineurin inhibitors, or immunosuppressants, although 10% of pregnant women received systemic corticosteroids for their AD.

Dr. Thyssen reported serving as a scientific adviser and paid speaker for Leo Pharma, Roche, Eli Lilly, and Sanofi-Genzyme, although this study was conducted without commercial support.

bjancin@mdedge.com

PARIS – Women with active atopic dermatitis during pregnancy and their physicians can find reassurance in the Danish national experience over an 18-year period, which showed no increased risk of pregnancy and birth problems other than modestly increased risks of premature rupture of membranes and neonatal staphylococcal septicemia, according to Jacob P. Thyssen, MD, PhD.

Bruce Jancin/MDedge News

At a session of the European Task Force of Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology, he presented a case control study of 10,668 births to Danish women with atopic dermatitis (AD) during 1997-2014. They were matched 1:10 by age, parity, and birth year to mothers without AD.

The risk of premature rupture of membranes was 15% higher in mothers with AD. And while the increased relative risk of neonatal staphylococcal septicemia was more substantial – a 145% increase – this was in fact a rare complication, observed Dr. Thyssen, a dermatologist at the University of Copenhagen.

There was no significant difference between women with or without AD in rates of preeclampsia, prematurity, pregnancy-induced hypertension, placenta previa, placental abruption, neonatal nonstaphylococcal septicemia, or other complications. The two groups had a similar number of visits to physicians and midwives during pregnancy.

Moreover, although the body mass index was similar in women with or without AD, the risk of gestational diabetes in women with the disease was significantly reduced by 21%; their risk of having a large-for-gestational-age baby with a birth weight of 4,500 g or more was also significantly lower than in controls.

Women received less treatment for AD during their pregnancy than they did beforehand. While pregnant, their disease was managed predominantly with topical corticosteroids and UV therapy. There was very little use of superpotent topical steroids, topical calcineurin inhibitors, or immunosuppressants, although 10% of pregnant women received systemic corticosteroids for their AD.

Dr. Thyssen reported serving as a scientific adviser and paid speaker for Leo Pharma, Roche, Eli Lilly, and Sanofi-Genzyme, although this study was conducted without commercial support.

bjancin@mdedge.com

PARIS – Women with active atopic dermatitis during pregnancy and their physicians can find reassurance in the Danish national experience over an 18-year period, which showed no increased risk of pregnancy and birth problems other than modestly increased risks of premature rupture of membranes and neonatal staphylococcal septicemia, according to Jacob P. Thyssen, MD, PhD.

Bruce Jancin/MDedge News

At a session of the European Task Force of Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology, he presented a case control study of 10,668 births to Danish women with atopic dermatitis (AD) during 1997-2014. They were matched 1:10 by age, parity, and birth year to mothers without AD.

The risk of premature rupture of membranes was 15% higher in mothers with AD. And while the increased relative risk of neonatal staphylococcal septicemia was more substantial – a 145% increase – this was in fact a rare complication, observed Dr. Thyssen, a dermatologist at the University of Copenhagen.

There was no significant difference between women with or without AD in rates of preeclampsia, prematurity, pregnancy-induced hypertension, placenta previa, placental abruption, neonatal nonstaphylococcal septicemia, or other complications. The two groups had a similar number of visits to physicians and midwives during pregnancy.

Moreover, although the body mass index was similar in women with or without AD, the risk of gestational diabetes in women with the disease was significantly reduced by 21%; their risk of having a large-for-gestational-age baby with a birth weight of 4,500 g or more was also significantly lower than in controls.

Women received less treatment for AD during their pregnancy than they did beforehand. While pregnant, their disease was managed predominantly with topical corticosteroids and UV therapy. There was very little use of superpotent topical steroids, topical calcineurin inhibitors, or immunosuppressants, although 10% of pregnant women received systemic corticosteroids for their AD.

Dr. Thyssen reported serving as a scientific adviser and paid speaker for Leo Pharma, Roche, Eli Lilly, and Sanofi-Genzyme, although this study was conducted without commercial support.

bjancin@mdedge.com

PARIS – Difelikefalin, an investigational peripheral kappa opioid receptor agonist, significantly reduced moderate to severe chronic itching while achieving across-the-board clinically meaningful improvements in quality of life measures in patients with hemodialysis-associated pruritus in a phase 2 study, Frédérique Menzaghi, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

At present there is no approved medication in the United States or Europe for the often intense itching associated with chronic kidney disease. Off-label treatments have limited efficacy.

Dr. Menzaghi is senior vice president for research and development at Cara Therapeutics, which is developing difelikefalin.

More than half – 60% to 70% – of patients on hemodialysis for end-stage renal disease experience chronic pruritus, as do a smaller proportion of individuals with chronic kidney disease (CKD) not requiring dialysis. CKD-associated pruritus is a day-and-night itch that makes life miserable for affected patients. Not only must they endure the predictable complications of skin excoriation, including impetigo, ulcerations, papules, and prurigo nodularis, but they also experience sleep disruption, depressed mood, and a 10%-20% increased mortality risk compared with CKD patients without pruritus.

Difelikefalin is a potent and selective peripheral kappa opioid receptor agonist that doesn’t activate mu or delta opioid receptors. It’s a synthetic drug that mimics endogenous dynorphin. Its key attribute is that it doesn’t cross the blood/brain barrier, so it doesn’t pose a risk for adverse events caused by activation of central opioid receptors. Difelikefalin has two mechanisms of action in CKD-associated pruritus: an antipruritic effect due to inhibition of ion channels responsible for afferent peripheral nerve activity; and an anti-inflammatory effect mediated by activation of kappa opioid receptors expressed by immune system cells, according to Dr. Menzaghi.

She reported on 174 hemodialysis patients with moderate to severe CKD-associated pruritus who were randomized to a double-blind, phase 2, dose-ranging study featuring an intravenous bolus of difelikefalin at 0.5, 1.0, or 1.5 mcg/kg or placebo given immediately after each of the thrice-weekly hemodialysis sessions for 8 weeks.

An oral formulation of difelikefalin is also under investigation for treatment of CKD-associated pruritus. The IV version is being developed for hemodialysis patients because difelikefalin is renally excreted.

“We’re taking advantage of the fact that their kidneys aren’t working. The drug stays in the system until the next dialysis because it can’t be eliminated. It’s quite convenient for these patients,” she explained.

The primary endpoint in the phase 2 study was change from baseline through week 8 in the weekly average of a patient’s daily self-rated 0-10 worst itching intensity numeric rating scale (NRS) scores. All participants had to have a baseline NRS score of at least 4, considered the lower threshold for moderate itch. In fact, the mean baseline score was 6.7-7.1 in the four study arms.
 

The results

Sixty-four percent of patients on difelikefalin 0.5 mcg/kg – the most effective dose – experienced at least a 3-point reduction, compared with 29% of placebo-treated controls. And a 4-point or greater reduction in NRS from baseline was documented in 51% of patients on difelikefalin at 0.5 mcg/kg, compared with 24% of controls.

Although a 4-point difference is widely considered to represent clinically meaningful improvement in atopic dermatitis studies, Dr. Menzaghi said psychometric analyses of the difelikefalin trial data indicated that a 3-point or greater improvement in NRS score was associated with clinically meaningful change.

“Our data suggest that a 4-point change may not be generalizable to all conditions,” she said.

Hemodialysis patients with severe baseline itch typically improved to moderate itch on difelikefalin, while those with baseline moderate itch – that is, an NRS of 4-6 – dropped down to mild or no itch while on the drug.

“But that’s just a number. The question is, is that really clinically meaningful?” Dr. Menzaghi noted.

The answer, she continued, is yes. A high correlation was seen between reduction in itch intensity and improvement in quality of life. Scores on the 5-D Itch Scale and Skindex-10 improved two- to threefold more in the difelikefalin 0.5-mcg group than in controls. So did scores on the 12-item Medical Outcomes Study Sleep Scale assessing sleep restlessness, awakening during sleep, and trouble falling asleep.

“We think these results suggest that peripheral kappa opioid receptors play an integral role in the modulation of itch signals and represent a primary target for the development of antipruritic agents,” said Dr. Menzaghi.

Indeed, a phase 3 randomized trial of difelikefalin 0.5 mcg/kg versus placebo in 350 hemodialysis patients with CKD-associated itch is ongoing in the United States, Europe, Australia, and Korea. Also ongoing is a phase 2 U.S. study of oral difelikefalin in patients with CKD-associated pruritus, many of whom are not on hemodialysis. In January, the company announced that enrollment in a phase 3 U.S. study of difelikefalin injection (0.5 mcg/kg) in hemodialysis patients with moderate to severe CKD-associated pruritus had been completed. The trials are funded by Cara Therapeutics.

bjancin@mdedge.com

SOURCE: Menzaghi F. EADV Congress, Abstract FC0.4.7.

PARIS – Difelikefalin, an investigational peripheral kappa opioid receptor agonist, significantly reduced moderate to severe chronic itching while achieving across-the-board clinically meaningful improvements in quality of life measures in patients with hemodialysis-associated pruritus in a phase 2 study, Frédérique Menzaghi, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

At present there is no approved medication in the United States or Europe for the often intense itching associated with chronic kidney disease. Off-label treatments have limited efficacy.

Dr. Menzaghi is senior vice president for research and development at Cara Therapeutics, which is developing difelikefalin.

More than half – 60% to 70% – of patients on hemodialysis for end-stage renal disease experience chronic pruritus, as do a smaller proportion of individuals with chronic kidney disease (CKD) not requiring dialysis. CKD-associated pruritus is a day-and-night itch that makes life miserable for affected patients. Not only must they endure the predictable complications of skin excoriation, including impetigo, ulcerations, papules, and prurigo nodularis, but they also experience sleep disruption, depressed mood, and a 10%-20% increased mortality risk compared with CKD patients without pruritus.

Difelikefalin is a potent and selective peripheral kappa opioid receptor agonist that doesn’t activate mu or delta opioid receptors. It’s a synthetic drug that mimics endogenous dynorphin. Its key attribute is that it doesn’t cross the blood/brain barrier, so it doesn’t pose a risk for adverse events caused by activation of central opioid receptors. Difelikefalin has two mechanisms of action in CKD-associated pruritus: an antipruritic effect due to inhibition of ion channels responsible for afferent peripheral nerve activity; and an anti-inflammatory effect mediated by activation of kappa opioid receptors expressed by immune system cells, according to Dr. Menzaghi.

She reported on 174 hemodialysis patients with moderate to severe CKD-associated pruritus who were randomized to a double-blind, phase 2, dose-ranging study featuring an intravenous bolus of difelikefalin at 0.5, 1.0, or 1.5 mcg/kg or placebo given immediately after each of the thrice-weekly hemodialysis sessions for 8 weeks.

An oral formulation of difelikefalin is also under investigation for treatment of CKD-associated pruritus. The IV version is being developed for hemodialysis patients because difelikefalin is renally excreted.

“We’re taking advantage of the fact that their kidneys aren’t working. The drug stays in the system until the next dialysis because it can’t be eliminated. It’s quite convenient for these patients,” she explained.

The primary endpoint in the phase 2 study was change from baseline through week 8 in the weekly average of a patient’s daily self-rated 0-10 worst itching intensity numeric rating scale (NRS) scores. All participants had to have a baseline NRS score of at least 4, considered the lower threshold for moderate itch. In fact, the mean baseline score was 6.7-7.1 in the four study arms.
 

The results

Sixty-four percent of patients on difelikefalin 0.5 mcg/kg – the most effective dose – experienced at least a 3-point reduction, compared with 29% of placebo-treated controls. And a 4-point or greater reduction in NRS from baseline was documented in 51% of patients on difelikefalin at 0.5 mcg/kg, compared with 24% of controls.

Although a 4-point difference is widely considered to represent clinically meaningful improvement in atopic dermatitis studies, Dr. Menzaghi said psychometric analyses of the difelikefalin trial data indicated that a 3-point or greater improvement in NRS score was associated with clinically meaningful change.

“Our data suggest that a 4-point change may not be generalizable to all conditions,” she said.

Hemodialysis patients with severe baseline itch typically improved to moderate itch on difelikefalin, while those with baseline moderate itch – that is, an NRS of 4-6 – dropped down to mild or no itch while on the drug.

“But that’s just a number. The question is, is that really clinically meaningful?” Dr. Menzaghi noted.

The answer, she continued, is yes. A high correlation was seen between reduction in itch intensity and improvement in quality of life. Scores on the 5-D Itch Scale and Skindex-10 improved two- to threefold more in the difelikefalin 0.5-mcg group than in controls. So did scores on the 12-item Medical Outcomes Study Sleep Scale assessing sleep restlessness, awakening during sleep, and trouble falling asleep.

“We think these results suggest that peripheral kappa opioid receptors play an integral role in the modulation of itch signals and represent a primary target for the development of antipruritic agents,” said Dr. Menzaghi.

Indeed, a phase 3 randomized trial of difelikefalin 0.5 mcg/kg versus placebo in 350 hemodialysis patients with CKD-associated itch is ongoing in the United States, Europe, Australia, and Korea. Also ongoing is a phase 2 U.S. study of oral difelikefalin in patients with CKD-associated pruritus, many of whom are not on hemodialysis. In January, the company announced that enrollment in a phase 3 U.S. study of difelikefalin injection (0.5 mcg/kg) in hemodialysis patients with moderate to severe CKD-associated pruritus had been completed. The trials are funded by Cara Therapeutics.

bjancin@mdedge.com

SOURCE: Menzaghi F. EADV Congress, Abstract FC0.4.7.

PARIS – Difelikefalin, an investigational peripheral kappa opioid receptor agonist, significantly reduced moderate to severe chronic itching while achieving across-the-board clinically meaningful improvements in quality of life measures in patients with hemodialysis-associated pruritus in a phase 2 study, Frédérique Menzaghi, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

At present there is no approved medication in the United States or Europe for the often intense itching associated with chronic kidney disease. Off-label treatments have limited efficacy.

Dr. Menzaghi is senior vice president for research and development at Cara Therapeutics, which is developing difelikefalin.

More than half – 60% to 70% – of patients on hemodialysis for end-stage renal disease experience chronic pruritus, as do a smaller proportion of individuals with chronic kidney disease (CKD) not requiring dialysis. CKD-associated pruritus is a day-and-night itch that makes life miserable for affected patients. Not only must they endure the predictable complications of skin excoriation, including impetigo, ulcerations, papules, and prurigo nodularis, but they also experience sleep disruption, depressed mood, and a 10%-20% increased mortality risk compared with CKD patients without pruritus.

Difelikefalin is a potent and selective peripheral kappa opioid receptor agonist that doesn’t activate mu or delta opioid receptors. It’s a synthetic drug that mimics endogenous dynorphin. Its key attribute is that it doesn’t cross the blood/brain barrier, so it doesn’t pose a risk for adverse events caused by activation of central opioid receptors. Difelikefalin has two mechanisms of action in CKD-associated pruritus: an antipruritic effect due to inhibition of ion channels responsible for afferent peripheral nerve activity; and an anti-inflammatory effect mediated by activation of kappa opioid receptors expressed by immune system cells, according to Dr. Menzaghi.

She reported on 174 hemodialysis patients with moderate to severe CKD-associated pruritus who were randomized to a double-blind, phase 2, dose-ranging study featuring an intravenous bolus of difelikefalin at 0.5, 1.0, or 1.5 mcg/kg or placebo given immediately after each of the thrice-weekly hemodialysis sessions for 8 weeks.

An oral formulation of difelikefalin is also under investigation for treatment of CKD-associated pruritus. The IV version is being developed for hemodialysis patients because difelikefalin is renally excreted.

“We’re taking advantage of the fact that their kidneys aren’t working. The drug stays in the system until the next dialysis because it can’t be eliminated. It’s quite convenient for these patients,” she explained.

The primary endpoint in the phase 2 study was change from baseline through week 8 in the weekly average of a patient’s daily self-rated 0-10 worst itching intensity numeric rating scale (NRS) scores. All participants had to have a baseline NRS score of at least 4, considered the lower threshold for moderate itch. In fact, the mean baseline score was 6.7-7.1 in the four study arms.
 

The results

Sixty-four percent of patients on difelikefalin 0.5 mcg/kg – the most effective dose – experienced at least a 3-point reduction, compared with 29% of placebo-treated controls. And a 4-point or greater reduction in NRS from baseline was documented in 51% of patients on difelikefalin at 0.5 mcg/kg, compared with 24% of controls.

Although a 4-point difference is widely considered to represent clinically meaningful improvement in atopic dermatitis studies, Dr. Menzaghi said psychometric analyses of the difelikefalin trial data indicated that a 3-point or greater improvement in NRS score was associated with clinically meaningful change.

“Our data suggest that a 4-point change may not be generalizable to all conditions,” she said.

Hemodialysis patients with severe baseline itch typically improved to moderate itch on difelikefalin, while those with baseline moderate itch – that is, an NRS of 4-6 – dropped down to mild or no itch while on the drug.

“But that’s just a number. The question is, is that really clinically meaningful?” Dr. Menzaghi noted.

The answer, she continued, is yes. A high correlation was seen between reduction in itch intensity and improvement in quality of life. Scores on the 5-D Itch Scale and Skindex-10 improved two- to threefold more in the difelikefalin 0.5-mcg group than in controls. So did scores on the 12-item Medical Outcomes Study Sleep Scale assessing sleep restlessness, awakening during sleep, and trouble falling asleep.

“We think these results suggest that peripheral kappa opioid receptors play an integral role in the modulation of itch signals and represent a primary target for the development of antipruritic agents,” said Dr. Menzaghi.

Indeed, a phase 3 randomized trial of difelikefalin 0.5 mcg/kg versus placebo in 350 hemodialysis patients with CKD-associated itch is ongoing in the United States, Europe, Australia, and Korea. Also ongoing is a phase 2 U.S. study of oral difelikefalin in patients with CKD-associated pruritus, many of whom are not on hemodialysis. In January, the company announced that enrollment in a phase 3 U.S. study of difelikefalin injection (0.5 mcg/kg) in hemodialysis patients with moderate to severe CKD-associated pruritus had been completed. The trials are funded by Cara Therapeutics.

bjancin@mdedge.com

SOURCE: Menzaghi F. EADV Congress, Abstract FC0.4.7.

Making art is not only life enriching—it can help reduce stress and anxiety, provide emotional release, relieve depression, and boost self-esteem. That is why art therapy has been a valuable part of VA mental health services since 1945. Plein air painting—painting outdoors “in the fresh air”—gives an added dimension to that. It can be both calming and energizing, offers challenges not found in a studio setting, teaches observation, and can lead to rewarding social interactions and connections. Not least, there is the benefit of being surrounded by nature.

The publishers and editor of Plein Air magazine wanted to introduce more veterans to the pleasures and benefits of outdoor painting, so they created the Plein Air Force Veterans Squad. Dennis Tyson, Commander of the Veterans Squad, says the goal is to “[s]how our gratitude to veterans by teaching them painting, allowing them to enjoy the benefits and stress reduction that come with painting outdoors.” The program seeks to enlist painters from around the nation to visit veterans’ groups, do demonstrations, and offer free lessons. The guiding principle, Tyson says, is that cost should not prevent any veteran from participating, so lessons and supplies are free or low-cost.

The program runs 2 websites. PleinAirForce.com gives existing plein air painters “missions” and tools to spread the word about plein air painting. That site provides scripts, posters, and guidance on promoting speaking engagements. A main purpose is to drive veterans and others interested in learning to the second website, PaintOutside.com, “so we can give them encouragement, free lessons, tips and tools to start painting.” PaintOutside.com also offers a directory of artists who teach, and a directory of “painting buddies.”

In addition to the websites, interested veterans can get more information at www.facebook.com/pleinairmagazine.

Making art is not only life enriching—it can help reduce stress and anxiety, provide emotional release, relieve depression, and boost self-esteem. That is why art therapy has been a valuable part of VA mental health services since 1945. Plein air painting—painting outdoors “in the fresh air”—gives an added dimension to that. It can be both calming and energizing, offers challenges not found in a studio setting, teaches observation, and can lead to rewarding social interactions and connections. Not least, there is the benefit of being surrounded by nature.

The publishers and editor of Plein Air magazine wanted to introduce more veterans to the pleasures and benefits of outdoor painting, so they created the Plein Air Force Veterans Squad. Dennis Tyson, Commander of the Veterans Squad, says the goal is to “[s]how our gratitude to veterans by teaching them painting, allowing them to enjoy the benefits and stress reduction that come with painting outdoors.” The program seeks to enlist painters from around the nation to visit veterans’ groups, do demonstrations, and offer free lessons. The guiding principle, Tyson says, is that cost should not prevent any veteran from participating, so lessons and supplies are free or low-cost.

The program runs 2 websites. PleinAirForce.com gives existing plein air painters “missions” and tools to spread the word about plein air painting. That site provides scripts, posters, and guidance on promoting speaking engagements. A main purpose is to drive veterans and others interested in learning to the second website, PaintOutside.com, “so we can give them encouragement, free lessons, tips and tools to start painting.” PaintOutside.com also offers a directory of artists who teach, and a directory of “painting buddies.”

In addition to the websites, interested veterans can get more information at www.facebook.com/pleinairmagazine.

Making art is not only life enriching—it can help reduce stress and anxiety, provide emotional release, relieve depression, and boost self-esteem. That is why art therapy has been a valuable part of VA mental health services since 1945. Plein air painting—painting outdoors “in the fresh air”—gives an added dimension to that. It can be both calming and energizing, offers challenges not found in a studio setting, teaches observation, and can lead to rewarding social interactions and connections. Not least, there is the benefit of being surrounded by nature.

The publishers and editor of Plein Air magazine wanted to introduce more veterans to the pleasures and benefits of outdoor painting, so they created the Plein Air Force Veterans Squad. Dennis Tyson, Commander of the Veterans Squad, says the goal is to “[s]how our gratitude to veterans by teaching them painting, allowing them to enjoy the benefits and stress reduction that come with painting outdoors.” The program seeks to enlist painters from around the nation to visit veterans’ groups, do demonstrations, and offer free lessons. The guiding principle, Tyson says, is that cost should not prevent any veteran from participating, so lessons and supplies are free or low-cost.

The program runs 2 websites. PleinAirForce.com gives existing plein air painters “missions” and tools to spread the word about plein air painting. That site provides scripts, posters, and guidance on promoting speaking engagements. A main purpose is to drive veterans and others interested in learning to the second website, PaintOutside.com, “so we can give them encouragement, free lessons, tips and tools to start painting.” PaintOutside.com also offers a directory of artists who teach, and a directory of “painting buddies.”

In addition to the websites, interested veterans can get more information at www.facebook.com/pleinairmagazine.

Among white women, obesity is positively associated with depressive symptoms across all income levels. However, among black women, no such associations are found – regardless of income. Meanwhile, among men, the link between obesity and depression appears strong for black men with high household incomes, a cross-sectional analysis of 12,220 adults suggests.

“This work underscores the importance of disentangling the association of race and [socioeconomic status] to gain a better understanding of how each operates to impact health outcomes,” wrote Caryn N. Bell, PhD, and her associates. The report is in Preventive Medicine.

The study comprised 3,755 black subjects, 55.5% of whom were women, and 8,465 white subjects, 51.8% of whom were women. They completed a detailed questionnaire as part of the 2007-2014 National Health and Nutrition Examination Survey and had a physical exam. Depressive symptoms were measured by the Patient Health Questionnaire-9 (PHQ-9), and obesity was defined as a body mass index of 30 kg/m² or higher. About 1% of both black and white subjects had severe depressive symptoms, meaning a PHQ-9 score ranging from 20 to 27 points.

A greater percentage of black participants were obese (47.3% vs. 34.4%), and black participants were less likely to live in a household earning $100,000 per year or more (10.9% vs. 28.3%). Black participants were a bit younger (mean age 44.8 years vs. 49.2 years), and less likely to be currently married, college graduates, insured, and physically active. A higher percentage reported fair to poor health (23.9% vs. 14.6%). The differences were statistically significant.

For white women, the association between obesity and depression held across all income levels. For black women, this association was not found at any income level. For black men, the link between obesity and depression was limited to those with a household income of $100,000 or more (odds ratio, 4.65; 95% confidence interval, 1.48-14.59). And for white men, the association was limited to those with a household income of $35,000-$74,999 (OR, 1.44; 95% CI, 1.02-2.03).

The effect of race on obesity and depression has been well studied – it’s known, for instance, that the association between obesity and depression is strongest among white women – but the role of income as a modifier has not been well addressed, wrote Dr. Bell, an assistant professor in the department of African American studies at the University of Maryland, College Park, and her associates.

“Though major life-time depression is less prevalent among African Americans, those who are obese should be screened for depression at similar rates as whites, particularly high-income African American men,” Dr. Bell and her associates wrote.

As for explanations, the authors suggested that strong, antiobesity stigma “may be present among white women at all income levels,” and may drive depression regardless of how much they make.

The prevalence of depressive symptoms at specific income levels among men suggests that something other than stigma is at work. Depression among obese, middle-income white men might be tied to “an unmeasured factor like subjective social status.” Meanwhile, obese black men with high household incomes “have less income and wealth than their white counterparts” because “of various forms of structural racism. ... This may be manifested with higher rates of depression through obesity-related factors like unhealthy coping behaviors and stress,” the investigators said.

Dr. Bell and her associates cited a few limitations. One is that the study looked only at those factors among black and white people. “Results could differ with other ethnic groups,” they wrote. In addition, income was self-reported, and three-way interactions – which are tough to interpret – were used. Nevertheless, they said, the study results have key public health implications.

The study had no financial disclosures, and the investigators reported having no conflicts of interest.

aotto@mdedge.com

SOURCE: Bell CN et al. Prev Med. 2018 Dec 3. doi: 10.1016/j.ypmed.2018.11.024.

Among white women, obesity is positively associated with depressive symptoms across all income levels. However, among black women, no such associations are found – regardless of income. Meanwhile, among men, the link between obesity and depression appears strong for black men with high household incomes, a cross-sectional analysis of 12,220 adults suggests.

“This work underscores the importance of disentangling the association of race and [socioeconomic status] to gain a better understanding of how each operates to impact health outcomes,” wrote Caryn N. Bell, PhD, and her associates. The report is in Preventive Medicine.

The study comprised 3,755 black subjects, 55.5% of whom were women, and 8,465 white subjects, 51.8% of whom were women. They completed a detailed questionnaire as part of the 2007-2014 National Health and Nutrition Examination Survey and had a physical exam. Depressive symptoms were measured by the Patient Health Questionnaire-9 (PHQ-9), and obesity was defined as a body mass index of 30 kg/m² or higher. About 1% of both black and white subjects had severe depressive symptoms, meaning a PHQ-9 score ranging from 20 to 27 points.

A greater percentage of black participants were obese (47.3% vs. 34.4%), and black participants were less likely to live in a household earning $100,000 per year or more (10.9% vs. 28.3%). Black participants were a bit younger (mean age 44.8 years vs. 49.2 years), and less likely to be currently married, college graduates, insured, and physically active. A higher percentage reported fair to poor health (23.9% vs. 14.6%). The differences were statistically significant.

For white women, the association between obesity and depression held across all income levels. For black women, this association was not found at any income level. For black men, the link between obesity and depression was limited to those with a household income of $100,000 or more (odds ratio, 4.65; 95% confidence interval, 1.48-14.59). And for white men, the association was limited to those with a household income of $35,000-$74,999 (OR, 1.44; 95% CI, 1.02-2.03).

The effect of race on obesity and depression has been well studied – it’s known, for instance, that the association between obesity and depression is strongest among white women – but the role of income as a modifier has not been well addressed, wrote Dr. Bell, an assistant professor in the department of African American studies at the University of Maryland, College Park, and her associates.

“Though major life-time depression is less prevalent among African Americans, those who are obese should be screened for depression at similar rates as whites, particularly high-income African American men,” Dr. Bell and her associates wrote.

As for explanations, the authors suggested that strong, antiobesity stigma “may be present among white women at all income levels,” and may drive depression regardless of how much they make.

The prevalence of depressive symptoms at specific income levels among men suggests that something other than stigma is at work. Depression among obese, middle-income white men might be tied to “an unmeasured factor like subjective social status.” Meanwhile, obese black men with high household incomes “have less income and wealth than their white counterparts” because “of various forms of structural racism. ... This may be manifested with higher rates of depression through obesity-related factors like unhealthy coping behaviors and stress,” the investigators said.

Dr. Bell and her associates cited a few limitations. One is that the study looked only at those factors among black and white people. “Results could differ with other ethnic groups,” they wrote. In addition, income was self-reported, and three-way interactions – which are tough to interpret – were used. Nevertheless, they said, the study results have key public health implications.

The study had no financial disclosures, and the investigators reported having no conflicts of interest.

aotto@mdedge.com

SOURCE: Bell CN et al. Prev Med. 2018 Dec 3. doi: 10.1016/j.ypmed.2018.11.024.

Among white women, obesity is positively associated with depressive symptoms across all income levels. However, among black women, no such associations are found – regardless of income. Meanwhile, among men, the link between obesity and depression appears strong for black men with high household incomes, a cross-sectional analysis of 12,220 adults suggests.

“This work underscores the importance of disentangling the association of race and [socioeconomic status] to gain a better understanding of how each operates to impact health outcomes,” wrote Caryn N. Bell, PhD, and her associates. The report is in Preventive Medicine.

The study comprised 3,755 black subjects, 55.5% of whom were women, and 8,465 white subjects, 51.8% of whom were women. They completed a detailed questionnaire as part of the 2007-2014 National Health and Nutrition Examination Survey and had a physical exam. Depressive symptoms were measured by the Patient Health Questionnaire-9 (PHQ-9), and obesity was defined as a body mass index of 30 kg/m² or higher. About 1% of both black and white subjects had severe depressive symptoms, meaning a PHQ-9 score ranging from 20 to 27 points.

A greater percentage of black participants were obese (47.3% vs. 34.4%), and black participants were less likely to live in a household earning $100,000 per year or more (10.9% vs. 28.3%). Black participants were a bit younger (mean age 44.8 years vs. 49.2 years), and less likely to be currently married, college graduates, insured, and physically active. A higher percentage reported fair to poor health (23.9% vs. 14.6%). The differences were statistically significant.

For white women, the association between obesity and depression held across all income levels. For black women, this association was not found at any income level. For black men, the link between obesity and depression was limited to those with a household income of $100,000 or more (odds ratio, 4.65; 95% confidence interval, 1.48-14.59). And for white men, the association was limited to those with a household income of $35,000-$74,999 (OR, 1.44; 95% CI, 1.02-2.03).

The effect of race on obesity and depression has been well studied – it’s known, for instance, that the association between obesity and depression is strongest among white women – but the role of income as a modifier has not been well addressed, wrote Dr. Bell, an assistant professor in the department of African American studies at the University of Maryland, College Park, and her associates.

“Though major life-time depression is less prevalent among African Americans, those who are obese should be screened for depression at similar rates as whites, particularly high-income African American men,” Dr. Bell and her associates wrote.

As for explanations, the authors suggested that strong, antiobesity stigma “may be present among white women at all income levels,” and may drive depression regardless of how much they make.

The prevalence of depressive symptoms at specific income levels among men suggests that something other than stigma is at work. Depression among obese, middle-income white men might be tied to “an unmeasured factor like subjective social status.” Meanwhile, obese black men with high household incomes “have less income and wealth than their white counterparts” because “of various forms of structural racism. ... This may be manifested with higher rates of depression through obesity-related factors like unhealthy coping behaviors and stress,” the investigators said.

Dr. Bell and her associates cited a few limitations. One is that the study looked only at those factors among black and white people. “Results could differ with other ethnic groups,” they wrote. In addition, income was self-reported, and three-way interactions – which are tough to interpret – were used. Nevertheless, they said, the study results have key public health implications.

The study had no financial disclosures, and the investigators reported having no conflicts of interest.

aotto@mdedge.com

SOURCE: Bell CN et al. Prev Med. 2018 Dec 3. doi: 10.1016/j.ypmed.2018.11.024.

BOSTON – The higher the comorbidity burden, the greater the likelihood that osteomyelitis will lead to amputation within 2 years, according to a review of 1,186 adult osteomyelitis patients at the University of Michigan, Ann Arbor.

WILLSIE/Getty Images

The limb amputation incidence was 7.2% over 2 years in patients with no comorbidities, 21.4% among patients with heart failure, 36.1% in patients with diabetes, and 36.7% among those with peripheral vascular disease (PVD).

The 2-year incidence marched steadily upward with combined comorbidities to 47.4% in patients with diabetes and heart failure; 64.5% in patients with diabetes and PVD; and 75.0% in patients with diabetes, heart failure, and PVD.

“What this means is that looking at diabetes versus no diabetes alone is not sufficient to gauge the risk of amputation. We have to look at the patient’s comorbidity profile as a whole; greater comorbidity burden and different combinations of comorbidities [increase] amputation incidence, but there’s considerable risk [7.2%] even among otherwise healthy patients,” said lead investigator Toby Keeney-Bonthrone, a medical student at the university.

The ultimate goal of the work is to develop an osteomyelitis amputation risk calculator for physicians and patients to improve decision making, validated by nationwide data. “The question is if some patients would benefit from [an earlier,] more prophylactic amputation. Would it be better to just take off the limb and be done with it, and would that decrease overall morbidity?” he said at the annual clinical congress of the American College of Surgeons.

“We often find ourselves reacting to osteomyelitis as it progresses. I think patients deserve a better deal than that. They deserve for us to think one or two steps ahead,” Mr. Keeney-Bonthrone said.

The immediate goal of the study was to fill the data gap on long-term osteomyelitis outcomes, something that hasn’t been addressed much in the literature. The team reviewed adult patients from 2004 to 2015 who were followed for at least 2 years after diagnosis; 610 had diabetes, a known risk factor for osteomyelitis and amputation, and 576 did not.

Comorbidities were considerably more common in the diabetes group, including PVD and heart failure, but also chronic obstructive pulmonary disease, previous heart attack, prior amputation, and especially renal disease. The 2-year amputation incidence was also higher in the diabetes group (43.1% vs. 12.3%), as was 2-year mortality (22.3% vs. 15.5%).

Odds ratios for lower limb amputation climbed in a stepwise fashion on multivariate analysis, from almost a 100% increase in men and in black patients to a 158% increase among patients with past amputations; a 206% increase with PVD; a 256% increase in patients with type 2 diabetes, and a 349% increase among patients with type 1 diabetes. The investigators were puzzled that the amputation risk was higher among type 1 patients than in those with type 2, because comorbidity burdens are generally higher in type 2 diabetes.

No data was provided on treatment differences between the groups, including antibiotic use.

The work was funded by the National Institutes of Health. The investigators reported no relevant disclosures.

aotto@mdedge.com

SOURCE: Keeney-Bonthrone T et al. J Am Coll Surg. 2018 Oct;227(4), S105.

BOSTON – The higher the comorbidity burden, the greater the likelihood that osteomyelitis will lead to amputation within 2 years, according to a review of 1,186 adult osteomyelitis patients at the University of Michigan, Ann Arbor.

WILLSIE/Getty Images

The limb amputation incidence was 7.2% over 2 years in patients with no comorbidities, 21.4% among patients with heart failure, 36.1% in patients with diabetes, and 36.7% among those with peripheral vascular disease (PVD).

The 2-year incidence marched steadily upward with combined comorbidities to 47.4% in patients with diabetes and heart failure; 64.5% in patients with diabetes and PVD; and 75.0% in patients with diabetes, heart failure, and PVD.

“What this means is that looking at diabetes versus no diabetes alone is not sufficient to gauge the risk of amputation. We have to look at the patient’s comorbidity profile as a whole; greater comorbidity burden and different combinations of comorbidities [increase] amputation incidence, but there’s considerable risk [7.2%] even among otherwise healthy patients,” said lead investigator Toby Keeney-Bonthrone, a medical student at the university.

The ultimate goal of the work is to develop an osteomyelitis amputation risk calculator for physicians and patients to improve decision making, validated by nationwide data. “The question is if some patients would benefit from [an earlier,] more prophylactic amputation. Would it be better to just take off the limb and be done with it, and would that decrease overall morbidity?” he said at the annual clinical congress of the American College of Surgeons.

“We often find ourselves reacting to osteomyelitis as it progresses. I think patients deserve a better deal than that. They deserve for us to think one or two steps ahead,” Mr. Keeney-Bonthrone said.

The immediate goal of the study was to fill the data gap on long-term osteomyelitis outcomes, something that hasn’t been addressed much in the literature. The team reviewed adult patients from 2004 to 2015 who were followed for at least 2 years after diagnosis; 610 had diabetes, a known risk factor for osteomyelitis and amputation, and 576 did not.

Comorbidities were considerably more common in the diabetes group, including PVD and heart failure, but also chronic obstructive pulmonary disease, previous heart attack, prior amputation, and especially renal disease. The 2-year amputation incidence was also higher in the diabetes group (43.1% vs. 12.3%), as was 2-year mortality (22.3% vs. 15.5%).

Odds ratios for lower limb amputation climbed in a stepwise fashion on multivariate analysis, from almost a 100% increase in men and in black patients to a 158% increase among patients with past amputations; a 206% increase with PVD; a 256% increase in patients with type 2 diabetes, and a 349% increase among patients with type 1 diabetes. The investigators were puzzled that the amputation risk was higher among type 1 patients than in those with type 2, because comorbidity burdens are generally higher in type 2 diabetes.

No data was provided on treatment differences between the groups, including antibiotic use.

The work was funded by the National Institutes of Health. The investigators reported no relevant disclosures.

aotto@mdedge.com

SOURCE: Keeney-Bonthrone T et al. J Am Coll Surg. 2018 Oct;227(4), S105.

BOSTON – The higher the comorbidity burden, the greater the likelihood that osteomyelitis will lead to amputation within 2 years, according to a review of 1,186 adult osteomyelitis patients at the University of Michigan, Ann Arbor.

WILLSIE/Getty Images

The limb amputation incidence was 7.2% over 2 years in patients with no comorbidities, 21.4% among patients with heart failure, 36.1% in patients with diabetes, and 36.7% among those with peripheral vascular disease (PVD).

The 2-year incidence marched steadily upward with combined comorbidities to 47.4% in patients with diabetes and heart failure; 64.5% in patients with diabetes and PVD; and 75.0% in patients with diabetes, heart failure, and PVD.

“What this means is that looking at diabetes versus no diabetes alone is not sufficient to gauge the risk of amputation. We have to look at the patient’s comorbidity profile as a whole; greater comorbidity burden and different combinations of comorbidities [increase] amputation incidence, but there’s considerable risk [7.2%] even among otherwise healthy patients,” said lead investigator Toby Keeney-Bonthrone, a medical student at the university.

The ultimate goal of the work is to develop an osteomyelitis amputation risk calculator for physicians and patients to improve decision making, validated by nationwide data. “The question is if some patients would benefit from [an earlier,] more prophylactic amputation. Would it be better to just take off the limb and be done with it, and would that decrease overall morbidity?” he said at the annual clinical congress of the American College of Surgeons.

“We often find ourselves reacting to osteomyelitis as it progresses. I think patients deserve a better deal than that. They deserve for us to think one or two steps ahead,” Mr. Keeney-Bonthrone said.

The immediate goal of the study was to fill the data gap on long-term osteomyelitis outcomes, something that hasn’t been addressed much in the literature. The team reviewed adult patients from 2004 to 2015 who were followed for at least 2 years after diagnosis; 610 had diabetes, a known risk factor for osteomyelitis and amputation, and 576 did not.

Comorbidities were considerably more common in the diabetes group, including PVD and heart failure, but also chronic obstructive pulmonary disease, previous heart attack, prior amputation, and especially renal disease. The 2-year amputation incidence was also higher in the diabetes group (43.1% vs. 12.3%), as was 2-year mortality (22.3% vs. 15.5%).

Odds ratios for lower limb amputation climbed in a stepwise fashion on multivariate analysis, from almost a 100% increase in men and in black patients to a 158% increase among patients with past amputations; a 206% increase with PVD; a 256% increase in patients with type 2 diabetes, and a 349% increase among patients with type 1 diabetes. The investigators were puzzled that the amputation risk was higher among type 1 patients than in those with type 2, because comorbidity burdens are generally higher in type 2 diabetes.

No data was provided on treatment differences between the groups, including antibiotic use.

The work was funded by the National Institutes of Health. The investigators reported no relevant disclosures.

aotto@mdedge.com

SOURCE: Keeney-Bonthrone T et al. J Am Coll Surg. 2018 Oct;227(4), S105.

LAS VEGAS – An estimated 15%-25% of women aged 18-50 years suffer from chronic pelvic pain, a condition that commonly leads to sick days, reduced activity, and higher medication use. Treatments like surgery and opioids may seem feasible, but an obstetrician-gynecologist who studies pain urged colleagues to think twice.

KatarzynaBialasiewicz/Thinkstock

In some cases, pelvic pain patients may suffer from centralized pain syndromes, conditions linked to the central nervous system that may not respond well to those common treatments, said Sawsan As-Sanie, MD, MPH, director of the University of Michigan Endometriosis Center, Ann Arbor.

“If we have laser vision on the pelvis, we may help some patients, but many of us will do harm,” said Dr. As-Sanie, who spoke at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Endometriosis is frequently linked to pelvic pain. But, she said, the link between the two is fuzzier than has been assumed.

“It would make sense that endometriosis or pelvic adhesions would activate nociceptive pain, and [there are] a lot of data to support that this is, in part, how endometriosis causes pain,” she said. “But I would argue it really isn’t that simple because the relationship between endometriosis and pelvic pain is very complex and not explained entirely by the lesion.” For example, “we know that pain recurs after medical and surgical therapy, often without evidence of recurrent endometriosis.” And, there’s little relationship between pain symptoms and the location or extent of endometriosis.

What’s going on? Dr. As-Sanie suggested central pain syndromes can play a significant role in pelvic pain. These syndromes are 1.5-2 times more common in women than men, and are triggered or exacerbated by stressors.

She also emphasized the wide-ranging effects of these syndromes. “We focus on pain, but it’s clearly not a just a pain disorder,” noting that patients can report fatigue, poor sleep, greater sensitivity to light and sound, and memory difficulties that produce “fibromyalgia fog.”

Research suggests that patients with central pain syndromes experience changes in both brain structure and function, she said. As for pelvic pain specifically, studies have linked it to increased pain sensitivity and altered central nervous system structure and function regardless of whether endometriosis is present.

How should patients with pelvic pain be treated in light of this information? Dr. As-Sanie suggests first trying “gold standard” approaches to treat contributing factors whether they’re gynecologic, urologic, gastrointestinal, musculoskeletal or nerve related.

If those strategies don’t work, she said, “consider treating centralized pain” with a blend of approaches: behavioral (such as diet and cognitive-behavior therapy), medical (such as hormone modulation), and interventional (such as physical therapy and surgery).

Also consider pharmacologic therapies, said Dr. As-Sanie, who identified dual reuptake inhibitors (venlafaxine [Effexor] and duloxetine [Cymbalta] are a class of antidepressants that block the reuptake of both serotonin and norepinephrine) and anticonvulsants as drugs with strong evidence as treatments for central pain syndromes.

“Start at low doses and titrate up,” she advised, and “if at any point a given medication doesn’t work, we should try another.”

The Pelvic Anatomy and Gynecologic Surgery Symposium was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Dr. As-Sanie discloses she is a consultant for AbbVie and Myovant.

LAS VEGAS – An estimated 15%-25% of women aged 18-50 years suffer from chronic pelvic pain, a condition that commonly leads to sick days, reduced activity, and higher medication use. Treatments like surgery and opioids may seem feasible, but an obstetrician-gynecologist who studies pain urged colleagues to think twice.

KatarzynaBialasiewicz/Thinkstock

In some cases, pelvic pain patients may suffer from centralized pain syndromes, conditions linked to the central nervous system that may not respond well to those common treatments, said Sawsan As-Sanie, MD, MPH, director of the University of Michigan Endometriosis Center, Ann Arbor.

“If we have laser vision on the pelvis, we may help some patients, but many of us will do harm,” said Dr. As-Sanie, who spoke at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Endometriosis is frequently linked to pelvic pain. But, she said, the link between the two is fuzzier than has been assumed.

“It would make sense that endometriosis or pelvic adhesions would activate nociceptive pain, and [there are] a lot of data to support that this is, in part, how endometriosis causes pain,” she said. “But I would argue it really isn’t that simple because the relationship between endometriosis and pelvic pain is very complex and not explained entirely by the lesion.” For example, “we know that pain recurs after medical and surgical therapy, often without evidence of recurrent endometriosis.” And, there’s little relationship between pain symptoms and the location or extent of endometriosis.

What’s going on? Dr. As-Sanie suggested central pain syndromes can play a significant role in pelvic pain. These syndromes are 1.5-2 times more common in women than men, and are triggered or exacerbated by stressors.

She also emphasized the wide-ranging effects of these syndromes. “We focus on pain, but it’s clearly not a just a pain disorder,” noting that patients can report fatigue, poor sleep, greater sensitivity to light and sound, and memory difficulties that produce “fibromyalgia fog.”

Research suggests that patients with central pain syndromes experience changes in both brain structure and function, she said. As for pelvic pain specifically, studies have linked it to increased pain sensitivity and altered central nervous system structure and function regardless of whether endometriosis is present.

How should patients with pelvic pain be treated in light of this information? Dr. As-Sanie suggests first trying “gold standard” approaches to treat contributing factors whether they’re gynecologic, urologic, gastrointestinal, musculoskeletal or nerve related.

If those strategies don’t work, she said, “consider treating centralized pain” with a blend of approaches: behavioral (such as diet and cognitive-behavior therapy), medical (such as hormone modulation), and interventional (such as physical therapy and surgery).

Also consider pharmacologic therapies, said Dr. As-Sanie, who identified dual reuptake inhibitors (venlafaxine [Effexor] and duloxetine [Cymbalta] are a class of antidepressants that block the reuptake of both serotonin and norepinephrine) and anticonvulsants as drugs with strong evidence as treatments for central pain syndromes.

“Start at low doses and titrate up,” she advised, and “if at any point a given medication doesn’t work, we should try another.”

The Pelvic Anatomy and Gynecologic Surgery Symposium was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Dr. As-Sanie discloses she is a consultant for AbbVie and Myovant.

LAS VEGAS – An estimated 15%-25% of women aged 18-50 years suffer from chronic pelvic pain, a condition that commonly leads to sick days, reduced activity, and higher medication use. Treatments like surgery and opioids may seem feasible, but an obstetrician-gynecologist who studies pain urged colleagues to think twice.

KatarzynaBialasiewicz/Thinkstock

In some cases, pelvic pain patients may suffer from centralized pain syndromes, conditions linked to the central nervous system that may not respond well to those common treatments, said Sawsan As-Sanie, MD, MPH, director of the University of Michigan Endometriosis Center, Ann Arbor.

“If we have laser vision on the pelvis, we may help some patients, but many of us will do harm,” said Dr. As-Sanie, who spoke at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Endometriosis is frequently linked to pelvic pain. But, she said, the link between the two is fuzzier than has been assumed.

“It would make sense that endometriosis or pelvic adhesions would activate nociceptive pain, and [there are] a lot of data to support that this is, in part, how endometriosis causes pain,” she said. “But I would argue it really isn’t that simple because the relationship between endometriosis and pelvic pain is very complex and not explained entirely by the lesion.” For example, “we know that pain recurs after medical and surgical therapy, often without evidence of recurrent endometriosis.” And, there’s little relationship between pain symptoms and the location or extent of endometriosis.

What’s going on? Dr. As-Sanie suggested central pain syndromes can play a significant role in pelvic pain. These syndromes are 1.5-2 times more common in women than men, and are triggered or exacerbated by stressors.

She also emphasized the wide-ranging effects of these syndromes. “We focus on pain, but it’s clearly not a just a pain disorder,” noting that patients can report fatigue, poor sleep, greater sensitivity to light and sound, and memory difficulties that produce “fibromyalgia fog.”

Research suggests that patients with central pain syndromes experience changes in both brain structure and function, she said. As for pelvic pain specifically, studies have linked it to increased pain sensitivity and altered central nervous system structure and function regardless of whether endometriosis is present.

How should patients with pelvic pain be treated in light of this information? Dr. As-Sanie suggests first trying “gold standard” approaches to treat contributing factors whether they’re gynecologic, urologic, gastrointestinal, musculoskeletal or nerve related.

If those strategies don’t work, she said, “consider treating centralized pain” with a blend of approaches: behavioral (such as diet and cognitive-behavior therapy), medical (such as hormone modulation), and interventional (such as physical therapy and surgery).

Also consider pharmacologic therapies, said Dr. As-Sanie, who identified dual reuptake inhibitors (venlafaxine [Effexor] and duloxetine [Cymbalta] are a class of antidepressants that block the reuptake of both serotonin and norepinephrine) and anticonvulsants as drugs with strong evidence as treatments for central pain syndromes.

“Start at low doses and titrate up,” she advised, and “if at any point a given medication doesn’t work, we should try another.”

The Pelvic Anatomy and Gynecologic Surgery Symposium was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Dr. As-Sanie discloses she is a consultant for AbbVie and Myovant.

Although sleep is critical to patient recovery in the hospital, hospitalization is not restful,^1,2 and inpatient sleep deprivation has been linked to poor health outcomes.^1-4 The American Academy of Nursing’s Choosing Wisely^® campaign recommends nurses reduce unnecessary nocturnal care.⁵ However, interventions to improve inpatient sleep are not widely implemented.⁶ Targeting routine disruptions, such as overnight vital signs, by changing default settings in the electronic health record (EHR)with “nudges” could be a cost-effective strategy to improve inpatient sleep.^4,7

We created Sleep for Inpatients: Empowering Staff to Act (SIESTA), which pairs nudges in the EHR with interprofessional education and empowerment,⁸ and tested its effectiveness on objectively and subjectively measured nocturnal sleep disruptors.

Study Design

Two 18-room University of Chicago Medicine general-medicine units were used in this prospective study. The SIESTA-enhanced unit underwent the full sleep intervention: nursing education and empowerment, physician education, and EHR changes. The standard unit did not receive nursing interventions but received all other forms of intervention. Because physicians simultaneously cared for patients on both units, all internal medicine residents and hospitalists received the same education. The study population included physicians, nurses, and awake English-speaking patients who were cognitively intact and admitted to these two units. The University of Chicago Institutional Review Board approved this study (12-1766; 16685B).

Development of SIESTA

To develop SIESTA, patients were surveyed, and focus groups of staff were conducted; overnight vitals, medications, and phlebotomy were identified as major barriers to patient sleep.⁹ We found that physicians did not know how to change the default vital signs order “every 4 hours” or how to batch-order morning phlebotomy at a time other than 4:00 am. Nurses reported having to wake patients up at 1:00 am for q8h subcutaneous heparin.

Behavioral Nudges

The SIESTA team worked with clinical informaticists to change the default orders in Epic^TM (Epic Systems Corporation, 2017, Verona, Wisconsin) in September 2015 so that physicians would be asked, “Continue vital signs throughout the night?”¹⁰ Previously, this question was marked “Yes” by default and hidden. While the default protocol for heparin q8h was maintained, heparin q12h (9:00 am and 9:00 pm) was introduced as an option, since q12h heparin is equally effective for VTE prophylaxis.¹¹ Laboratory ordering was streamlined so that physicians could batch-order laboratory draws at 6:00 am or 10:00 pm.

SIESTA Physician Education

We created a 20-minute presentation on the consequences and causes of in-hospital sleep deprivation and evidence-based behavioral modification. We distributed pocket cards describing the mnemonic SIESTA (Screen patients for sleep disorders, Instruct patients on sleep hygiene, Eliminate disruptions, Shut doors, Treat pain, and Alarm and noise control). Physicians were instructed to consider forgoing overnight vitals, using clinical judgment to identify stable patients, use a sleep-promoting VTE prophylaxis option, and order daily labs at 10:00 pm or 6:00 am. An online educational module was sent to staff who missed live sessions due to days off.

SIESTA-Enhanced Unit

In the SIESTA-enhanced unit, nurses received education using pocket cards and were coached to collaborate with physicians to implement sleep-friendly orders. Customized signage depicting empowered nurses advocating for patients was posted near the huddle board. Because these nurses suggested adding SIESTA to the nurses’ ongoing daily huddles at 4:00 pm and 3:00 am, beginning on January 1, 2016, nurses were asked to identify at least two stable patients for sleep-friendly orders at the huddle. Night nurses incorporated SIESTA into their handoff to day nurses for eligible patients. Day nurses would then call physicians to advocate changing of orders.

Data Collection

Objectively Measured Sleep Disruptors

Adoption of SIESTA orders from March 2015 to March 2016 was assessed with a monthly Epic^TM Clarity report. From August 1, 2015 to April 1, 2016, nocturnal room entries were recorded using the GOJO SMARTLINK^TM Hand Hygiene system (GOJO Industries Inc., 2017, Akron, Ohio). This system includes two components: the hand-sanitizer dispensers, which track dispenses (numerator), and door-mounted Activity Counters, which use heat sensors that react to body heat emitted by a person passing through the doorway (denominator for hand-hygiene compliance). For our analysis, we only used Activity Counter data, which count room entries and exits, regardless of whether sanitizer was dispensed.

Patient-Reported Nighttime Sleep Disruptions

From June 2015 to March 2016, research assistants administered a 10-item Potential Hospital Sleep Disruptions and Noises Questionnaire (PHSDNQ) to patients in both units. Responses to this questionnaire correlate with actigraphy-based sleep measurements.^9,12,13 Surveys were administered every other weekday to patients available to participate (eg, willing to participate, on the unit, awake). Survey data were stored on the REDCap Database (Version 6.14.0; Vanderbilt University, 2016, Nashville, Tennessee). Pre- and post-intervention Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) “top-box ratings” for percent quiet at night and percent pain well controlled were also compared.

Data Analysis

Objectively Measured Potential Sleep Disruptors

The proportion of sleep-friendly orders was analyzed using a two-sample test for proportions pre-post for the SIESTA-enhanced and standard units. The difference in use of SIESTA orders between units was analyzed via multivariable logistic regression, testing for independent associations between post-period, SIESTA-enhanced unit, and an interaction term (post-period × SIESTA unit) on use of sleep-friendly orders.

Room entries per night (11:00 pm–7:00 am) were analyzed via single-group interrupted time-series. Multiple Activity Counter entries within three minutes were counted as a single room entry. In addition, the pre-post cutoff was set to 7:00 am, September 8, 2015; after the SIESTA launch, a second cutoff marking when SIESTA was added to the nurses’ MDI Huddle was added at 7:00 am, January 1, 2016.

Patient-Reported Nighttime Sleep Disruptions

Per prior studies, we defined a score 2 or higher as “sleep disruption.”⁹ Differences between units were evaluated via multivariable logistic regression to examine the association between the interaction of post-period × SIESTA-enhanced unit and odds of not reporting a sleep disruption. Significance was denoted as P = .05.

Between March 2015 and March 2016, 1,083 general-medicine patients were admitted to the SIESTA-enhanced and standard units (Table).

Nocturnal Orders

From March 2015 to March 2016, 1,669 Epic^TM general medicine orders were reviewed (Figure). In the SIESTA-enhanced unit, the mean percentage of sleep-friendly orders rose for both vital signs (+31% [95% CI = 25%, 36%]; P < .001, n_pre = 306, n_post = 306] and VTE prophylaxis (+28% [95% CI = 18%, 37%]; P < .001, n_pre = 158, n_post = 173]. Similar changes were observed in the standard unit for sleep-friendly vital signs (+20% [95% CI = 14%, 25%]; P < .001, n_pre = 252, n_post = 219) and VTE prophylaxis (+16% [95% CI = 6%, 25%]; P = .002, n_pre = 130, n_post = 125). Differences between the two units were not statistically significant, and no significant change in timing of laboratory orders postintervention was found.

Nighttime Room Entries

Immediately after SIESTA launch, an average decrease of 114 total entries/night were noted in the SIESTA-enhanced unit, ([95% CI = −138, −91]; P < .001), corresponding to a 44% reduction (−6.3 entries/room) from the mean of 14.3 entries per patient room at baseline (Figure). No statistically significant change was seen in the standard unit. After SIESTA was incorporated into nursing huddles, total disruptions/night decreased by 1.31 disruptions/night ([95% CI = −1.64, −0.98]; P < .001) in the SIESTA-enhanced unit; by comparison, no significant changes were observed in the standard unit.

Patient-Reported Nighttime Sleep Disruptions

Between June 2015 and March 2016, 201 patient surveys were collected. A significant interaction was observed between the SIESTA-enhanced unit and post-period, and patients in the SIESTA-enhanced unit were more likely to report not being disrupted by medications (OR 4.08 [95% CI = 1.13–14.07]; P = .031) and vital signs (OR 3.35 [95% CI = 1.00–11.2]; P = .05) than those in the standard unit. HCAHPS top-box scores for the SIESTA unit increased by 7% for the “Quiet at night” category and 9% for the “Pain well controlled” category; by comparison, no major changes (>5%) were observed in the standard unit.

The present SIESTA intervention demonstrated that physician education coupled with EHR default changes are associated with a significant reduction in orders for overnight vital signs and medication administration in both units. However, addition of nursing education and empowerment in the SIESTA-enhanced unit was associated with fewer nocturnal room entries and improvements in patient-reported outcomes compared with those in the standard unit.

This study presents several implications for hospital initiatives aiming to improve patient sleep.¹⁴ Our study is consistent with other research highlighting the hypothesis that altering the default settings of EHR systems can influence physician behavior in a sustainable manner.¹⁵ However, our study also finds that, even when sleep-friendly orders are present, creating a sleep-friendly environment likely depends on the unit-based nurses championing the cause. While the initial decrease in nocturnal room entries post-SIESTA eventually faded, sustainable changes were observed only after SIESTA was added to nursing huddles, which illustrates the importance of using multiple methods to nudge staff.

Our study includes a number of limitations. It is not a randomized controlled trial, we cannot assume causality, and contamination was assumed, as residents and hospitalists worked in both units. Our single-site study may not be generalizable. Low HCAHPS response rates (10%-20%) also prevent demonstration of statistically significant differences. Finally, our convenience sampling strategy means not all inpatients were surveyed, and objective sleep duration was not measured.

In summary, at the University of Chicago, SIESTA could be associated with adoption of sleep-friendly vitals and medication orders, a decrease in nighttime room entries, and improved patient experience.

Disclosures

The authors have nothing to disclose.

Funding

This study was funded by the National Institute on Aging (NIA Grant No. T35AG029795) and the National Heart, Lung, and Blood Institute (NHLBI Grant Nos. R25HL116372 and K24HL136859).

Although sleep is critical to patient recovery in the hospital, hospitalization is not restful,^1,2 and inpatient sleep deprivation has been linked to poor health outcomes.^1-4 The American Academy of Nursing’s Choosing Wisely^® campaign recommends nurses reduce unnecessary nocturnal care.⁵ However, interventions to improve inpatient sleep are not widely implemented.⁶ Targeting routine disruptions, such as overnight vital signs, by changing default settings in the electronic health record (EHR)with “nudges” could be a cost-effective strategy to improve inpatient sleep.^4,7

We created Sleep for Inpatients: Empowering Staff to Act (SIESTA), which pairs nudges in the EHR with interprofessional education and empowerment,⁸ and tested its effectiveness on objectively and subjectively measured nocturnal sleep disruptors.

Study Design

Two 18-room University of Chicago Medicine general-medicine units were used in this prospective study. The SIESTA-enhanced unit underwent the full sleep intervention: nursing education and empowerment, physician education, and EHR changes. The standard unit did not receive nursing interventions but received all other forms of intervention. Because physicians simultaneously cared for patients on both units, all internal medicine residents and hospitalists received the same education. The study population included physicians, nurses, and awake English-speaking patients who were cognitively intact and admitted to these two units. The University of Chicago Institutional Review Board approved this study (12-1766; 16685B).

Development of SIESTA

To develop SIESTA, patients were surveyed, and focus groups of staff were conducted; overnight vitals, medications, and phlebotomy were identified as major barriers to patient sleep.⁹ We found that physicians did not know how to change the default vital signs order “every 4 hours” or how to batch-order morning phlebotomy at a time other than 4:00 am. Nurses reported having to wake patients up at 1:00 am for q8h subcutaneous heparin.

Behavioral Nudges

The SIESTA team worked with clinical informaticists to change the default orders in Epic^TM (Epic Systems Corporation, 2017, Verona, Wisconsin) in September 2015 so that physicians would be asked, “Continue vital signs throughout the night?”¹⁰ Previously, this question was marked “Yes” by default and hidden. While the default protocol for heparin q8h was maintained, heparin q12h (9:00 am and 9:00 pm) was introduced as an option, since q12h heparin is equally effective for VTE prophylaxis.¹¹ Laboratory ordering was streamlined so that physicians could batch-order laboratory draws at 6:00 am or 10:00 pm.

SIESTA Physician Education

We created a 20-minute presentation on the consequences and causes of in-hospital sleep deprivation and evidence-based behavioral modification. We distributed pocket cards describing the mnemonic SIESTA (Screen patients for sleep disorders, Instruct patients on sleep hygiene, Eliminate disruptions, Shut doors, Treat pain, and Alarm and noise control). Physicians were instructed to consider forgoing overnight vitals, using clinical judgment to identify stable patients, use a sleep-promoting VTE prophylaxis option, and order daily labs at 10:00 pm or 6:00 am. An online educational module was sent to staff who missed live sessions due to days off.

SIESTA-Enhanced Unit

In the SIESTA-enhanced unit, nurses received education using pocket cards and were coached to collaborate with physicians to implement sleep-friendly orders. Customized signage depicting empowered nurses advocating for patients was posted near the huddle board. Because these nurses suggested adding SIESTA to the nurses’ ongoing daily huddles at 4:00 pm and 3:00 am, beginning on January 1, 2016, nurses were asked to identify at least two stable patients for sleep-friendly orders at the huddle. Night nurses incorporated SIESTA into their handoff to day nurses for eligible patients. Day nurses would then call physicians to advocate changing of orders.

Data Collection

Objectively Measured Sleep Disruptors

Adoption of SIESTA orders from March 2015 to March 2016 was assessed with a monthly Epic^TM Clarity report. From August 1, 2015 to April 1, 2016, nocturnal room entries were recorded using the GOJO SMARTLINK^TM Hand Hygiene system (GOJO Industries Inc., 2017, Akron, Ohio). This system includes two components: the hand-sanitizer dispensers, which track dispenses (numerator), and door-mounted Activity Counters, which use heat sensors that react to body heat emitted by a person passing through the doorway (denominator for hand-hygiene compliance). For our analysis, we only used Activity Counter data, which count room entries and exits, regardless of whether sanitizer was dispensed.

Patient-Reported Nighttime Sleep Disruptions

From June 2015 to March 2016, research assistants administered a 10-item Potential Hospital Sleep Disruptions and Noises Questionnaire (PHSDNQ) to patients in both units. Responses to this questionnaire correlate with actigraphy-based sleep measurements.^9,12,13 Surveys were administered every other weekday to patients available to participate (eg, willing to participate, on the unit, awake). Survey data were stored on the REDCap Database (Version 6.14.0; Vanderbilt University, 2016, Nashville, Tennessee). Pre- and post-intervention Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) “top-box ratings” for percent quiet at night and percent pain well controlled were also compared.

Data Analysis

Objectively Measured Potential Sleep Disruptors

The proportion of sleep-friendly orders was analyzed using a two-sample test for proportions pre-post for the SIESTA-enhanced and standard units. The difference in use of SIESTA orders between units was analyzed via multivariable logistic regression, testing for independent associations between post-period, SIESTA-enhanced unit, and an interaction term (post-period × SIESTA unit) on use of sleep-friendly orders.

Room entries per night (11:00 pm–7:00 am) were analyzed via single-group interrupted time-series. Multiple Activity Counter entries within three minutes were counted as a single room entry. In addition, the pre-post cutoff was set to 7:00 am, September 8, 2015; after the SIESTA launch, a second cutoff marking when SIESTA was added to the nurses’ MDI Huddle was added at 7:00 am, January 1, 2016.

Patient-Reported Nighttime Sleep Disruptions

Per prior studies, we defined a score 2 or higher as “sleep disruption.”⁹ Differences between units were evaluated via multivariable logistic regression to examine the association between the interaction of post-period × SIESTA-enhanced unit and odds of not reporting a sleep disruption. Significance was denoted as P = .05.

Between March 2015 and March 2016, 1,083 general-medicine patients were admitted to the SIESTA-enhanced and standard units (Table).

Nocturnal Orders

From March 2015 to March 2016, 1,669 Epic^TM general medicine orders were reviewed (Figure). In the SIESTA-enhanced unit, the mean percentage of sleep-friendly orders rose for both vital signs (+31% [95% CI = 25%, 36%]; P < .001, n_pre = 306, n_post = 306] and VTE prophylaxis (+28% [95% CI = 18%, 37%]; P < .001, n_pre = 158, n_post = 173]. Similar changes were observed in the standard unit for sleep-friendly vital signs (+20% [95% CI = 14%, 25%]; P < .001, n_pre = 252, n_post = 219) and VTE prophylaxis (+16% [95% CI = 6%, 25%]; P = .002, n_pre = 130, n_post = 125). Differences between the two units were not statistically significant, and no significant change in timing of laboratory orders postintervention was found.

Nighttime Room Entries

Immediately after SIESTA launch, an average decrease of 114 total entries/night were noted in the SIESTA-enhanced unit, ([95% CI = −138, −91]; P < .001), corresponding to a 44% reduction (−6.3 entries/room) from the mean of 14.3 entries per patient room at baseline (Figure). No statistically significant change was seen in the standard unit. After SIESTA was incorporated into nursing huddles, total disruptions/night decreased by 1.31 disruptions/night ([95% CI = −1.64, −0.98]; P < .001) in the SIESTA-enhanced unit; by comparison, no significant changes were observed in the standard unit.

Patient-Reported Nighttime Sleep Disruptions

Between June 2015 and March 2016, 201 patient surveys were collected. A significant interaction was observed between the SIESTA-enhanced unit and post-period, and patients in the SIESTA-enhanced unit were more likely to report not being disrupted by medications (OR 4.08 [95% CI = 1.13–14.07]; P = .031) and vital signs (OR 3.35 [95% CI = 1.00–11.2]; P = .05) than those in the standard unit. HCAHPS top-box scores for the SIESTA unit increased by 7% for the “Quiet at night” category and 9% for the “Pain well controlled” category; by comparison, no major changes (>5%) were observed in the standard unit.

The present SIESTA intervention demonstrated that physician education coupled with EHR default changes are associated with a significant reduction in orders for overnight vital signs and medication administration in both units. However, addition of nursing education and empowerment in the SIESTA-enhanced unit was associated with fewer nocturnal room entries and improvements in patient-reported outcomes compared with those in the standard unit.

This study presents several implications for hospital initiatives aiming to improve patient sleep.¹⁴ Our study is consistent with other research highlighting the hypothesis that altering the default settings of EHR systems can influence physician behavior in a sustainable manner.¹⁵ However, our study also finds that, even when sleep-friendly orders are present, creating a sleep-friendly environment likely depends on the unit-based nurses championing the cause. While the initial decrease in nocturnal room entries post-SIESTA eventually faded, sustainable changes were observed only after SIESTA was added to nursing huddles, which illustrates the importance of using multiple methods to nudge staff.

Our study includes a number of limitations. It is not a randomized controlled trial, we cannot assume causality, and contamination was assumed, as residents and hospitalists worked in both units. Our single-site study may not be generalizable. Low HCAHPS response rates (10%-20%) also prevent demonstration of statistically significant differences. Finally, our convenience sampling strategy means not all inpatients were surveyed, and objective sleep duration was not measured.

In summary, at the University of Chicago, SIESTA could be associated with adoption of sleep-friendly vitals and medication orders, a decrease in nighttime room entries, and improved patient experience.

Disclosures

The authors have nothing to disclose.

Funding

This study was funded by the National Institute on Aging (NIA Grant No. T35AG029795) and the National Heart, Lung, and Blood Institute (NHLBI Grant Nos. R25HL116372 and K24HL136859).

Although sleep is critical to patient recovery in the hospital, hospitalization is not restful,^1,2 and inpatient sleep deprivation has been linked to poor health outcomes.^1-4 The American Academy of Nursing’s Choosing Wisely^® campaign recommends nurses reduce unnecessary nocturnal care.⁵ However, interventions to improve inpatient sleep are not widely implemented.⁶ Targeting routine disruptions, such as overnight vital signs, by changing default settings in the electronic health record (EHR)with “nudges” could be a cost-effective strategy to improve inpatient sleep.^4,7

We created Sleep for Inpatients: Empowering Staff to Act (SIESTA), which pairs nudges in the EHR with interprofessional education and empowerment,⁸ and tested its effectiveness on objectively and subjectively measured nocturnal sleep disruptors.

Study Design

Two 18-room University of Chicago Medicine general-medicine units were used in this prospective study. The SIESTA-enhanced unit underwent the full sleep intervention: nursing education and empowerment, physician education, and EHR changes. The standard unit did not receive nursing interventions but received all other forms of intervention. Because physicians simultaneously cared for patients on both units, all internal medicine residents and hospitalists received the same education. The study population included physicians, nurses, and awake English-speaking patients who were cognitively intact and admitted to these two units. The University of Chicago Institutional Review Board approved this study (12-1766; 16685B).

Development of SIESTA

To develop SIESTA, patients were surveyed, and focus groups of staff were conducted; overnight vitals, medications, and phlebotomy were identified as major barriers to patient sleep.⁹ We found that physicians did not know how to change the default vital signs order “every 4 hours” or how to batch-order morning phlebotomy at a time other than 4:00 am. Nurses reported having to wake patients up at 1:00 am for q8h subcutaneous heparin.

Behavioral Nudges

The SIESTA team worked with clinical informaticists to change the default orders in Epic^TM (Epic Systems Corporation, 2017, Verona, Wisconsin) in September 2015 so that physicians would be asked, “Continue vital signs throughout the night?”¹⁰ Previously, this question was marked “Yes” by default and hidden. While the default protocol for heparin q8h was maintained, heparin q12h (9:00 am and 9:00 pm) was introduced as an option, since q12h heparin is equally effective for VTE prophylaxis.¹¹ Laboratory ordering was streamlined so that physicians could batch-order laboratory draws at 6:00 am or 10:00 pm.

SIESTA Physician Education

We created a 20-minute presentation on the consequences and causes of in-hospital sleep deprivation and evidence-based behavioral modification. We distributed pocket cards describing the mnemonic SIESTA (Screen patients for sleep disorders, Instruct patients on sleep hygiene, Eliminate disruptions, Shut doors, Treat pain, and Alarm and noise control). Physicians were instructed to consider forgoing overnight vitals, using clinical judgment to identify stable patients, use a sleep-promoting VTE prophylaxis option, and order daily labs at 10:00 pm or 6:00 am. An online educational module was sent to staff who missed live sessions due to days off.

SIESTA-Enhanced Unit

In the SIESTA-enhanced unit, nurses received education using pocket cards and were coached to collaborate with physicians to implement sleep-friendly orders. Customized signage depicting empowered nurses advocating for patients was posted near the huddle board. Because these nurses suggested adding SIESTA to the nurses’ ongoing daily huddles at 4:00 pm and 3:00 am, beginning on January 1, 2016, nurses were asked to identify at least two stable patients for sleep-friendly orders at the huddle. Night nurses incorporated SIESTA into their handoff to day nurses for eligible patients. Day nurses would then call physicians to advocate changing of orders.

Data Collection

Objectively Measured Sleep Disruptors

Adoption of SIESTA orders from March 2015 to March 2016 was assessed with a monthly Epic^TM Clarity report. From August 1, 2015 to April 1, 2016, nocturnal room entries were recorded using the GOJO SMARTLINK^TM Hand Hygiene system (GOJO Industries Inc., 2017, Akron, Ohio). This system includes two components: the hand-sanitizer dispensers, which track dispenses (numerator), and door-mounted Activity Counters, which use heat sensors that react to body heat emitted by a person passing through the doorway (denominator for hand-hygiene compliance). For our analysis, we only used Activity Counter data, which count room entries and exits, regardless of whether sanitizer was dispensed.

Patient-Reported Nighttime Sleep Disruptions

From June 2015 to March 2016, research assistants administered a 10-item Potential Hospital Sleep Disruptions and Noises Questionnaire (PHSDNQ) to patients in both units. Responses to this questionnaire correlate with actigraphy-based sleep measurements.^9,12,13 Surveys were administered every other weekday to patients available to participate (eg, willing to participate, on the unit, awake). Survey data were stored on the REDCap Database (Version 6.14.0; Vanderbilt University, 2016, Nashville, Tennessee). Pre- and post-intervention Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) “top-box ratings” for percent quiet at night and percent pain well controlled were also compared.

Data Analysis

Objectively Measured Potential Sleep Disruptors

The proportion of sleep-friendly orders was analyzed using a two-sample test for proportions pre-post for the SIESTA-enhanced and standard units. The difference in use of SIESTA orders between units was analyzed via multivariable logistic regression, testing for independent associations between post-period, SIESTA-enhanced unit, and an interaction term (post-period × SIESTA unit) on use of sleep-friendly orders.

Room entries per night (11:00 pm–7:00 am) were analyzed via single-group interrupted time-series. Multiple Activity Counter entries within three minutes were counted as a single room entry. In addition, the pre-post cutoff was set to 7:00 am, September 8, 2015; after the SIESTA launch, a second cutoff marking when SIESTA was added to the nurses’ MDI Huddle was added at 7:00 am, January 1, 2016.

Patient-Reported Nighttime Sleep Disruptions

Per prior studies, we defined a score 2 or higher as “sleep disruption.”⁹ Differences between units were evaluated via multivariable logistic regression to examine the association between the interaction of post-period × SIESTA-enhanced unit and odds of not reporting a sleep disruption. Significance was denoted as P = .05.

Between March 2015 and March 2016, 1,083 general-medicine patients were admitted to the SIESTA-enhanced and standard units (Table).

Nocturnal Orders

From March 2015 to March 2016, 1,669 Epic^TM general medicine orders were reviewed (Figure). In the SIESTA-enhanced unit, the mean percentage of sleep-friendly orders rose for both vital signs (+31% [95% CI = 25%, 36%]; P < .001, n_pre = 306, n_post = 306] and VTE prophylaxis (+28% [95% CI = 18%, 37%]; P < .001, n_pre = 158, n_post = 173]. Similar changes were observed in the standard unit for sleep-friendly vital signs (+20% [95% CI = 14%, 25%]; P < .001, n_pre = 252, n_post = 219) and VTE prophylaxis (+16% [95% CI = 6%, 25%]; P = .002, n_pre = 130, n_post = 125). Differences between the two units were not statistically significant, and no significant change in timing of laboratory orders postintervention was found.

Nighttime Room Entries

Immediately after SIESTA launch, an average decrease of 114 total entries/night were noted in the SIESTA-enhanced unit, ([95% CI = −138, −91]; P < .001), corresponding to a 44% reduction (−6.3 entries/room) from the mean of 14.3 entries per patient room at baseline (Figure). No statistically significant change was seen in the standard unit. After SIESTA was incorporated into nursing huddles, total disruptions/night decreased by 1.31 disruptions/night ([95% CI = −1.64, −0.98]; P < .001) in the SIESTA-enhanced unit; by comparison, no significant changes were observed in the standard unit.

Patient-Reported Nighttime Sleep Disruptions

Between June 2015 and March 2016, 201 patient surveys were collected. A significant interaction was observed between the SIESTA-enhanced unit and post-period, and patients in the SIESTA-enhanced unit were more likely to report not being disrupted by medications (OR 4.08 [95% CI = 1.13–14.07]; P = .031) and vital signs (OR 3.35 [95% CI = 1.00–11.2]; P = .05) than those in the standard unit. HCAHPS top-box scores for the SIESTA unit increased by 7% for the “Quiet at night” category and 9% for the “Pain well controlled” category; by comparison, no major changes (>5%) were observed in the standard unit.

The present SIESTA intervention demonstrated that physician education coupled with EHR default changes are associated with a significant reduction in orders for overnight vital signs and medication administration in both units. However, addition of nursing education and empowerment in the SIESTA-enhanced unit was associated with fewer nocturnal room entries and improvements in patient-reported outcomes compared with those in the standard unit.

This study presents several implications for hospital initiatives aiming to improve patient sleep.¹⁴ Our study is consistent with other research highlighting the hypothesis that altering the default settings of EHR systems can influence physician behavior in a sustainable manner.¹⁵ However, our study also finds that, even when sleep-friendly orders are present, creating a sleep-friendly environment likely depends on the unit-based nurses championing the cause. While the initial decrease in nocturnal room entries post-SIESTA eventually faded, sustainable changes were observed only after SIESTA was added to nursing huddles, which illustrates the importance of using multiple methods to nudge staff.

Our study includes a number of limitations. It is not a randomized controlled trial, we cannot assume causality, and contamination was assumed, as residents and hospitalists worked in both units. Our single-site study may not be generalizable. Low HCAHPS response rates (10%-20%) also prevent demonstration of statistically significant differences. Finally, our convenience sampling strategy means not all inpatients were surveyed, and objective sleep duration was not measured.

In summary, at the University of Chicago, SIESTA could be associated with adoption of sleep-friendly vitals and medication orders, a decrease in nighttime room entries, and improved patient experience.

Disclosures

The authors have nothing to disclose.

Funding

This study was funded by the National Institute on Aging (NIA Grant No. T35AG029795) and the National Heart, Lung, and Blood Institute (NHLBI Grant Nos. R25HL116372 and K24HL136859).

With this issue, I officially assume the role of Editor-in-Chief of the Journal of Hospital Medicine. I am honored and humbled to serve as the third editor for this journal and thankful to my predecessors, Drs. Mark V. Williams and Andrew D. Auerbach, for establishing it as the premier forum for publication of research in hospital medicine.

The journal has always taken a broad view of its mission. Our focus on improving value and quality of healthcare for children and adults will continue. We are also well-positioned to expand our scope and publish the highest quality research and commentary on the evolving healthcare system, including adoption of new technology, population health management, and regionalization in healthcare, and our role within it. There is also increasing recognition that these trends have implications for patient experience and outcomes, healthcare professional well-being, and the learning environment. We welcome qualitative and quantitative research that provides insight into understanding and addressing these new challenges. We also seek your Perspectives in Hospital Medicine to highlight innovations or controversies in healthcare delivery or policy.

The journal landscape has evolved. We consume medical information in many different formats with a rapidly diminishing reliance on paper and ink. Rather than perusing a journal at the end of a busy workday, we now capitalize on small increments of time in between meetings or other activities. The journal has taken a leading role in engaging readers through social media (@JHospMedicine) with Twitter-based features such as journal clubs (#JHMChat) to discuss recently published research as well as visual abstracts to efficiently share scientific advances.¹ We will extend these efforts to include “tweetorials,” video abstracts, and a redesigned web presence, allowing us to transcend the constraints of traditional written articles. Our goals are to increase the visibility of authors and accessibility of their research, allow readers to engage with the journal in formats that best meet their needs, and enhance knowledge retention and knowledge translation to improve healthcare systems and patient outcomes.

The Journal of Hospital Medicine also strives to remain relevant to clinical practice through columns that seek to improve diagnostic reasoning (Clinical Care Conundrums), value and innovation in healthcare (Choosing Wisely: Things We Do For No Reason, Choosing Wisely: Next Steps in Improving Healthcare Value), and, through our long-form reviews, core medical knowledge. While in-depth reviews provide an important synthesis of a topic, our work environment and schedules are not always conducive to reading in this manner; busy clinicians may benefit from focused updates. We will introduce new shorter format reviews addressing clinical content, including practice guidelines, and research methodology.

Finally, we are invested in developing a leadership pipeline for academic medicine. Our Editorial Fellowship will provide educational experiences, professional development, and academic and networking opportunities for a cadre of young physicians.² A new column will highlight leadership and professional development lessons from renowned leaders from a broad range of disciplines. We also value diversity and inclusion. Disparities in academic medical leadership, though well-recognized, persist. For example, women now comprise more than half of all incoming medical students³ and 41% of faculty, yet only 24% of full professors, 18% of department chairs, and 17% of deans.⁴ This journal will play an important role in creating a diverse pipeline of academic leaders. We will lead by example and, in the coming year, develop approaches to create equity in all facets of journal leadership and authorship.

I am grateful to Dr. Auerbach for his visionary stewardship of the journal. As I take the helm, the journal will continue to evolve with the changing landscape of healthcare. I am fortunate to work with an exceptionally talented team, and I look forward to serving the journal and the field together to accomplish these goals.

Disclosures

The author has no financial conflicts of interest to disclose

With this issue, I officially assume the role of Editor-in-Chief of the Journal of Hospital Medicine. I am honored and humbled to serve as the third editor for this journal and thankful to my predecessors, Drs. Mark V. Williams and Andrew D. Auerbach, for establishing it as the premier forum for publication of research in hospital medicine.

The journal has always taken a broad view of its mission. Our focus on improving value and quality of healthcare for children and adults will continue. We are also well-positioned to expand our scope and publish the highest quality research and commentary on the evolving healthcare system, including adoption of new technology, population health management, and regionalization in healthcare, and our role within it. There is also increasing recognition that these trends have implications for patient experience and outcomes, healthcare professional well-being, and the learning environment. We welcome qualitative and quantitative research that provides insight into understanding and addressing these new challenges. We also seek your Perspectives in Hospital Medicine to highlight innovations or controversies in healthcare delivery or policy.

The journal landscape has evolved. We consume medical information in many different formats with a rapidly diminishing reliance on paper and ink. Rather than perusing a journal at the end of a busy workday, we now capitalize on small increments of time in between meetings or other activities. The journal has taken a leading role in engaging readers through social media (@JHospMedicine) with Twitter-based features such as journal clubs (#JHMChat) to discuss recently published research as well as visual abstracts to efficiently share scientific advances.¹ We will extend these efforts to include “tweetorials,” video abstracts, and a redesigned web presence, allowing us to transcend the constraints of traditional written articles. Our goals are to increase the visibility of authors and accessibility of their research, allow readers to engage with the journal in formats that best meet their needs, and enhance knowledge retention and knowledge translation to improve healthcare systems and patient outcomes.

The Journal of Hospital Medicine also strives to remain relevant to clinical practice through columns that seek to improve diagnostic reasoning (Clinical Care Conundrums), value and innovation in healthcare (Choosing Wisely: Things We Do For No Reason, Choosing Wisely: Next Steps in Improving Healthcare Value), and, through our long-form reviews, core medical knowledge. While in-depth reviews provide an important synthesis of a topic, our work environment and schedules are not always conducive to reading in this manner; busy clinicians may benefit from focused updates. We will introduce new shorter format reviews addressing clinical content, including practice guidelines, and research methodology.

Finally, we are invested in developing a leadership pipeline for academic medicine. Our Editorial Fellowship will provide educational experiences, professional development, and academic and networking opportunities for a cadre of young physicians.² A new column will highlight leadership and professional development lessons from renowned leaders from a broad range of disciplines. We also value diversity and inclusion. Disparities in academic medical leadership, though well-recognized, persist. For example, women now comprise more than half of all incoming medical students³ and 41% of faculty, yet only 24% of full professors, 18% of department chairs, and 17% of deans.⁴ This journal will play an important role in creating a diverse pipeline of academic leaders. We will lead by example and, in the coming year, develop approaches to create equity in all facets of journal leadership and authorship.

I am grateful to Dr. Auerbach for his visionary stewardship of the journal. As I take the helm, the journal will continue to evolve with the changing landscape of healthcare. I am fortunate to work with an exceptionally talented team, and I look forward to serving the journal and the field together to accomplish these goals.

Disclosures

The author has no financial conflicts of interest to disclose

With this issue, I officially assume the role of Editor-in-Chief of the Journal of Hospital Medicine. I am honored and humbled to serve as the third editor for this journal and thankful to my predecessors, Drs. Mark V. Williams and Andrew D. Auerbach, for establishing it as the premier forum for publication of research in hospital medicine.

The journal has always taken a broad view of its mission. Our focus on improving value and quality of healthcare for children and adults will continue. We are also well-positioned to expand our scope and publish the highest quality research and commentary on the evolving healthcare system, including adoption of new technology, population health management, and regionalization in healthcare, and our role within it. There is also increasing recognition that these trends have implications for patient experience and outcomes, healthcare professional well-being, and the learning environment. We welcome qualitative and quantitative research that provides insight into understanding and addressing these new challenges. We also seek your Perspectives in Hospital Medicine to highlight innovations or controversies in healthcare delivery or policy.

The journal landscape has evolved. We consume medical information in many different formats with a rapidly diminishing reliance on paper and ink. Rather than perusing a journal at the end of a busy workday, we now capitalize on small increments of time in between meetings or other activities. The journal has taken a leading role in engaging readers through social media (@JHospMedicine) with Twitter-based features such as journal clubs (#JHMChat) to discuss recently published research as well as visual abstracts to efficiently share scientific advances.¹ We will extend these efforts to include “tweetorials,” video abstracts, and a redesigned web presence, allowing us to transcend the constraints of traditional written articles. Our goals are to increase the visibility of authors and accessibility of their research, allow readers to engage with the journal in formats that best meet their needs, and enhance knowledge retention and knowledge translation to improve healthcare systems and patient outcomes.

The Journal of Hospital Medicine also strives to remain relevant to clinical practice through columns that seek to improve diagnostic reasoning (Clinical Care Conundrums), value and innovation in healthcare (Choosing Wisely: Things We Do For No Reason, Choosing Wisely: Next Steps in Improving Healthcare Value), and, through our long-form reviews, core medical knowledge. While in-depth reviews provide an important synthesis of a topic, our work environment and schedules are not always conducive to reading in this manner; busy clinicians may benefit from focused updates. We will introduce new shorter format reviews addressing clinical content, including practice guidelines, and research methodology.

Finally, we are invested in developing a leadership pipeline for academic medicine. Our Editorial Fellowship will provide educational experiences, professional development, and academic and networking opportunities for a cadre of young physicians.² A new column will highlight leadership and professional development lessons from renowned leaders from a broad range of disciplines. We also value diversity and inclusion. Disparities in academic medical leadership, though well-recognized, persist. For example, women now comprise more than half of all incoming medical students³ and 41% of faculty, yet only 24% of full professors, 18% of department chairs, and 17% of deans.⁴ This journal will play an important role in creating a diverse pipeline of academic leaders. We will lead by example and, in the coming year, develop approaches to create equity in all facets of journal leadership and authorship.

I am grateful to Dr. Auerbach for his visionary stewardship of the journal. As I take the helm, the journal will continue to evolve with the changing landscape of healthcare. I am fortunate to work with an exceptionally talented team, and I look forward to serving the journal and the field together to accomplish these goals.

Disclosures

The author has no financial conflicts of interest to disclose

The peer review and editorial processes are integral activities in academic medicine that provide ethical, independent, and unbiased critical assessment of submitted manuscripts to academic journals. Recognizing that few trainees or junior faculty are formally exposed to these processes,¹ the Journal of Hospital Medicine aims to fill this opportunity gap through the launch of a one-year Editorial Fellowship.

The Fellowship is open to chief residents, hospital medicine fellows, and junior faculty (eg, Assistant Professor or Clinical Instructor). Starting in July of each year, a group of four to six applicants are paired with editorial mentors who are current JHM Deputy or Associate Editors. Structured as a distance-learning program, this program aims to allow Fellows the ability to continue in their full time professional roles while also allowing the opportunity to engage with national leaders in hospital medicine. Regular communication and interactions take place through both synchronous and asynchronous means. Fellows’ responsibilities during the 12-month experience include: completion of six guided peer reviews, preparation of one or two editorials, participation in monthly editorial meetings, and quarterly educational videoconferences. Interested Fellows may also have an opportunity to co-lead the journal’s online journal club, #JHMChat.² Fellows are expected to attend the editorial staff meeting at the annual Society of Hospital Medicine Conference.

With this program, JHM aims to accomplish several tasks. First, we hope to offer a unique educational experience that allows for further growth, development, inspiration, and experience in academic medicine—specifically around the manuscript review and editorial processes. Second, recognizing that a journal’s quality is frequently a product of its reviewers, JHM hopes to build a cadre of well-trained and experienced reviewers and, hopefully, future members of the JHM editorial leadership team. Third, the program hopes to act as a networking experience, allowing editorial Fellows to learn from, collaborate with, and become academic leaders in the field. Finally, we hope to provide an opportunity for Fellows to be academically productive in their composition of editorial content—an output that will help catalyze their professional development.

We believe that in working closely with the JHM editorial staff, this program will help develop the next generation of leaders in academic hospital medicine. We strongly encourage applications from physicians who have been historically under-represented in leadership in academic medicine. Further details and the application can be found in the appendix and on the JHM website (www.journalofhospitalmedicine.com). It will be announced annually through the @JHospMedicine twitter handle.

Disclosures

The authors have nothing to disclose.

The peer review and editorial processes are integral activities in academic medicine that provide ethical, independent, and unbiased critical assessment of submitted manuscripts to academic journals. Recognizing that few trainees or junior faculty are formally exposed to these processes,¹ the Journal of Hospital Medicine aims to fill this opportunity gap through the launch of a one-year Editorial Fellowship.

The Fellowship is open to chief residents, hospital medicine fellows, and junior faculty (eg, Assistant Professor or Clinical Instructor). Starting in July of each year, a group of four to six applicants are paired with editorial mentors who are current JHM Deputy or Associate Editors. Structured as a distance-learning program, this program aims to allow Fellows the ability to continue in their full time professional roles while also allowing the opportunity to engage with national leaders in hospital medicine. Regular communication and interactions take place through both synchronous and asynchronous means. Fellows’ responsibilities during the 12-month experience include: completion of six guided peer reviews, preparation of one or two editorials, participation in monthly editorial meetings, and quarterly educational videoconferences. Interested Fellows may also have an opportunity to co-lead the journal’s online journal club, #JHMChat.² Fellows are expected to attend the editorial staff meeting at the annual Society of Hospital Medicine Conference.

With this program, JHM aims to accomplish several tasks. First, we hope to offer a unique educational experience that allows for further growth, development, inspiration, and experience in academic medicine—specifically around the manuscript review and editorial processes. Second, recognizing that a journal’s quality is frequently a product of its reviewers, JHM hopes to build a cadre of well-trained and experienced reviewers and, hopefully, future members of the JHM editorial leadership team. Third, the program hopes to act as a networking experience, allowing editorial Fellows to learn from, collaborate with, and become academic leaders in the field. Finally, we hope to provide an opportunity for Fellows to be academically productive in their composition of editorial content—an output that will help catalyze their professional development.

We believe that in working closely with the JHM editorial staff, this program will help develop the next generation of leaders in academic hospital medicine. We strongly encourage applications from physicians who have been historically under-represented in leadership in academic medicine. Further details and the application can be found in the appendix and on the JHM website (www.journalofhospitalmedicine.com). It will be announced annually through the @JHospMedicine twitter handle.

Disclosures

The authors have nothing to disclose.

The peer review and editorial processes are integral activities in academic medicine that provide ethical, independent, and unbiased critical assessment of submitted manuscripts to academic journals. Recognizing that few trainees or junior faculty are formally exposed to these processes,¹ the Journal of Hospital Medicine aims to fill this opportunity gap through the launch of a one-year Editorial Fellowship.

The Fellowship is open to chief residents, hospital medicine fellows, and junior faculty (eg, Assistant Professor or Clinical Instructor). Starting in July of each year, a group of four to six applicants are paired with editorial mentors who are current JHM Deputy or Associate Editors. Structured as a distance-learning program, this program aims to allow Fellows the ability to continue in their full time professional roles while also allowing the opportunity to engage with national leaders in hospital medicine. Regular communication and interactions take place through both synchronous and asynchronous means. Fellows’ responsibilities during the 12-month experience include: completion of six guided peer reviews, preparation of one or two editorials, participation in monthly editorial meetings, and quarterly educational videoconferences. Interested Fellows may also have an opportunity to co-lead the journal’s online journal club, #JHMChat.² Fellows are expected to attend the editorial staff meeting at the annual Society of Hospital Medicine Conference.

With this program, JHM aims to accomplish several tasks. First, we hope to offer a unique educational experience that allows for further growth, development, inspiration, and experience in academic medicine—specifically around the manuscript review and editorial processes. Second, recognizing that a journal’s quality is frequently a product of its reviewers, JHM hopes to build a cadre of well-trained and experienced reviewers and, hopefully, future members of the JHM editorial leadership team. Third, the program hopes to act as a networking experience, allowing editorial Fellows to learn from, collaborate with, and become academic leaders in the field. Finally, we hope to provide an opportunity for Fellows to be academically productive in their composition of editorial content—an output that will help catalyze their professional development.

We believe that in working closely with the JHM editorial staff, this program will help develop the next generation of leaders in academic hospital medicine. We strongly encourage applications from physicians who have been historically under-represented in leadership in academic medicine. Further details and the application can be found in the appendix and on the JHM website (www.journalofhospitalmedicine.com). It will be announced annually through the @JHospMedicine twitter handle.

Disclosures

The authors have nothing to disclose.

The Centers of Medicare and Medicaid Services (CMS) has introduced new payment models that tie quality and value incentives to 90% of fee-for-service payments and provide 50% of Medicare payments through alternative payment models.¹ The push toward value comes after productivity-based physician reimbursement (ie, fee for service) has been associated with poor quality care, including delayed diagnoses, complications, readmissions, increased length of stay, and high costs of care.^2-5 The method of physician payment is widely believed to affect clinical behavior by incentivizing doing more, coding for more, and billing for more.^6-7 Although payment systems may be used to achieve policy objectives,⁸ little is known about the association of different payment systems with the culture of delivering value-based care among frontline clinicians.

Culture is defined as a system of shared assumptions, values, beliefs, and norms within an environment and has a powerful role in shaping clinician practice patterns.^9-12 The culture within medicine currently contributes to the overuse of resources,^11,13 and a culture for improvement is correlated with clinical outcomes. A systematic review found a consistent association between positive organization culture and improved outcomes including mortality.¹⁴ Across health systems, institutions with high scores on patient safety culture surveys have shown improvements in clinical behaviors and patient outcomes.^15-18

In this study, we aim to describe high-value care culture among internal medicine hospitalists across diverse hospitals and evaluate the relationship between physician reimbursement and high-value care culture.

Study Design

This study is an observational, cross-sectional survey-based study of hospitalists from 12 hospitals in California between January and June 2016.

Study Population

A total of 12 hospitals with hospitalist programs in California were chosen to represent three types of hospitals (ie, four university, four community, and four safety net). Safety-net hospitals, which traditionally serve low-income and medically and socially vulnerable patients were defined as those in the top quartile (ie, greater than 0.5) of their Disproportionate Share Index (DSH), which measures Medicaid patient load.^19-20

To select hospitals with varying value-based care performance, we stratified using CMS value-based purchasing (VBP) scores from fiscal year 2015; these scores have been used to adjust reimbursement for just over 3,000 hospitals in the VBP program of CMS.^22,23 CMS calculates the VBP total performance score as a composite of four domains: (1) clinical processes of care (20% of total performance); (2) patient satisfaction (30%); (3) patient outcomes, including mortality and complications (30%); and (4) cost defined by Medicare payment per beneficiary (20%).²¹ Established quality measures are based on data reported by participating hospitals and chart abstraction during 2011-2014.²² Although other clinical measures of care intensity have been used as proxies of value-based care,^23,24 we used the measure of value that has been publically reported by the CMS VBP given its wide use and effects on reimbursements for 80% of hospitals in the CMS VBP program in 2015.²⁵ We obtained institution-level data from the CMS VBP Program and Hospital Compare files. Each of the three types of hospitals represented institutions with low, middle, and high VBP performance (split in tertiles) as reported by the CMS VBP program. To increase the number of participants in tertiles with fewer hospitalists, a fourth hospital was selected for each hospital type.

We excluded individual hospitalists who primarily identified as working in subspecialty divisions and those who spent less than eight weeks during the last year providing direct patient care on inpatient internal medicine services at the studied institution.

Measurement

Hospitalists were asked to complete the High-Value Care Culture Survey (HVCCS^TM), which measures the culture of value-based decision making among frontline clinicians.²⁶ Similar to other validated surveys for the assessment of patient safety culture,^27,28 the HVCCS can be used to identify target areas for improvement. The survey includes four domains: (1) leadership and health system messaging, (2) data transparency and access, (3) comfort with cost conversations, and (4) blame-free environment. This tool was developed by using a two-phase national modified Delphi process. It was evaluated at two academic centers to complete factor analysis and assess internal consistency, reliability, and validity among internal medicine hospitalists and residents. Validation included estimating product-moment correlation of overall HVCCS scores and domain scores with the CMS institutional VBP scores. HVCCS scores are standardized to a 0-100 point scale for each of the four domains and are then averaged to obtain an overall score.²⁶

In the survey, value was defined as the quality of care provided to patients in relation to the costs required to deliver that care, and high-value care was defined as care that tried to maximize quality while minimizing costs. Quality was defined as the degree to which health services increased the likelihood of desired health outcomes that are safe, effective, patient centered, timely, equitable, and consistent with current professional knowledge. Cost was defined as the negative financial, physical, and emotional effects on patients and the health system.²⁶

Data Analysis

We described the overall institutional mean high-value care culture and domain scores measured by the HVCCS, hospitalist demographics and training experiences, and hospital characteristics. We also described individual survey items. Descriptive statistics were stratified and compared on the basis of hospital type (ie, safety net, community, or university). We assessed the relationship between the clinician perception of reimbursement structure within their divisions and individually reported high-value care culture scores using bivariate and multilevel linear regression. We hypothesized that compared with hospitalists who were paid with salaries or wages, those who reported reimbursement with productivity adjustments may report lower HVCCS scores and those who reported reimbursement with quality or value adjustments may report higher HVCCS scores. We adjusted for physician- and hospital-level characteristics, including age, gender, and training track, and considered hospital type and size as random effects.

This study was approved by the Institutional Review Board at all 12 sites. All analyses were conducted using STATA^® 13.0 (College Station, Texas).

Hospitalist Characteristics

A total of 255 (68.9%, 255/370) hospitalists across all sites completed the survey. Of these respondents, 135 were female (50.6%). On average, hospitalists were 39 years of age (SD 6.8), trained in categorical tracks (221; 86.7%), and had previously trained for 14.3 months at a safety-net hospital (SD 14.2). In total, 166 hospitalists (65.1%) reported being paid with salary or wages, 77 (30.2%) with salary plus productivity adjustments, and 12 (4.7%) with salary plus quality or value adjustments. Moreover, 123 (48.6%) hospitalists agreed that funding for their group depended on the volume of services they delivered. Community-based hospitalists reported higher rates of reimbursement with salary plus productivity (47; 32.0%) compared with their counterparts from university-based (24; 28.2%) and safety-net based programs (6; 26.1%). Among the three different hospital types, significant differences exist in hospitalist mean age (P < .001), gender (P = .01), and the number of months training in a safety-net hospital (P = .02; Table 1).

Hospital Characteristics

Of the 12 study sites, four from each type of hospital (ie, safety-net based, community based, and university based) and four representing each value-based purchasing performance tertile (ie, high, middle, and low) were included. Eleven (91.7%) sites were located in urban areas with an average DSH index of 0.40 (SD 0.23), case mix index of 1.97 (SD 0.28), and bed size of 435.5 (SD 146.0; Table 1).

In multilevel regression modeling across all 12 sites, hospitalists from community-based hospitalist programs reported lower mean HVCCS scores (β = −4.4, 95% CI −8.1 to −0.7; Table 2) than those from other hospital types.

High-Value Care Culture Survey Scores

The mean HVCCS score was 50.2 (SD 13.6), and mean domain scores across all sites were 65.4 (SD 15.6) for leadership and health system messaging, 32.4 (SD 22.8) for data transparency and access, 52.1 (SD 19.7) for comfort with cost conversations, and 50.7 (SD 21.4) for blame-free environment (Table 1). For the majority (two-thirds) of individual HVCCS items, more than 30% of hospitalists across all sites agreed or strongly agreed that components of a low-value care culture exist within their institutions. For example, over 80% of hospitalists reported low transparency and limited access to data (see Appendix I for complete survey responses).

Hospitalists reported different HVCCS domains as strengths or weaknesses within their institutions in accordance with hospital type. Compared with university-based and safety-net-based hospitalists, community-based hospitalists reported lower scores in having a blame-free environment (466, SD 21.8). Nearly 50% reported that the clinicians’ fear of legal repercussions affects their frequency of ordering unneeded tests or procedures, and 30% reported that individual clinicians are blamed for complications. Nearly 40% reported that clinicians are uncomfortable discussing the costs of tests or treatments with patients and reported that clinicians do not feel that physicians should discuss costs with patients. Notably, community-based hospitalists uniquely differed in how they reported components of leadership and health system messaging. Over 60% reported a work climate or role modeling supportive of delivering quality care at lower costs. Only 48%, however, reported success seen from implemented efforts, and 45% reported weighing costs in clinical decision making (Table 1, Appendix I).

University-based hospitalists had significantly higher scores in leadership and health system messaging (67.4, SD 16.9) than community-based and safety-net-based hospitalists. They reported that their institutions consider their suggestions to improve quality care at low cost (75%), openly discuss ways to deliver this care (64%), and are actively implementing projects (73%). However, only 54% reported seeing success from implemented high-value care efforts (Table 1, Appendix I).

Safety-net hospitalists reported lower scores in leadership and health system messaging (56.8, SD 10.5) than university-based and community-based hospitalists. Few hospitalists reported a work climate (26%) or role modeling (30%) that is supportive of delivering quality care at low costs, openly discusses ways to deliver this care (35%), encourages frontline clinicians to pursue improvement projects (57%), or actively implements projects (26%). They also reported higher scores in the blame-free environment domain (59.8, SD 22.3; Table 1; Appendix 1).

Productivity Adjustments and High-Value Care Culture

In multilevel regression modeling, hospitalists who reported reimbursement with salary plus productivity adjustments had a lower mean HVCCS score (β = −6.2, 95% CI −9.9 to –2.5) than those who reported payment with salary or wages alone. Further multilevel regression modeling for each HVCCS domain revealed that hospitalists who reported reimbursement with salary plus productivity adjustments had lower scores in the leadership and health system messaging domain (β = −4.9, 95% CI −9.3 to −0.6) and data transparency and access domain (β = −10.7, 95% CI −16.7 to −4.6). No statistically significant difference was found between hospitalists who reported reimbursement with quality or value adjustments.

Understanding the drivers that are associated with a high-value care culture is necessary as payment models for hospitals transition from volume-based to value-based care. In this study, we found a meaningful association (β = −6.2) between clinician reimbursement schemes and measures of high-value care culture. A six-point change in the HVCCS score would correspond with a hospital moving from the top quartile to the median, which represents a significant change in performance. The relationship between clinician reimbursement schemes and high-value care culture may be a bidirectional relationship. Fee for service, the predominant payment scheme, places pressure on clinicians to maximize volume, focus on billing, and provide reactive care.^7,29 Conversely, payment schemes that avoid these incentives (ie, salary, wages, and adjustments for quality or value), especially if incentives are felt by frontline clinicians, may better align with goals for long-term health outcomes for patient populations and reduce excess visits and services.^2-6,8,30-34 At the same time, hospitals with a strong high-value care culture may be more likely to introduce shared savings programs and alternative payment models than those without. Through these decisions, the leadership can play an important role in creating an environment for change.³⁴ Similar to the study sites, hospitals in California have a higher percentage of risk-based payments than hospitals in other states (>22%)³⁵ and may also provide incentives to promote a high-value care culture or affect local physician compensation models.

Hospitals have options in how they choose to pay their clinicians, and these decisions may have downstream effects, such as building or eroding high-value care culture among clinicians or staff. A dose-response relationship between physician compensation models and value culture is plausible (salary with productivity < salary only < salary with value incentive). However, we did not find a statistically significant difference for salary with value incentive. This result may be attributed to the relatively small sample size in this study.

Hospitals can also improve their internal processes, organizational structure, and align their institutional payment contracts with those that emphasize value over fee-for-service-based incentives to increase value in care delivery.³⁶ The operation of hospitals is challenging when competing payment incentives are used at the same time,⁷ and leadership will likely achieve more success in improving a high-value care culture and value performance when all efforts, including clinician and institutional payment, are aligned.^37-38

Enduring large systems redesign will require directing attention to local organizational culture. For the majority of individual HVCCS items, 30% or more hospitalists across all sites agreed or strongly agreed that components of low-value care culture exist within their institutions. This response demonstrates a lack of focus on culture to address high-value care improvement among the study sites. Division and program leaders can begin measuring culture within their groups to develop new interventions that target culture change and improve value.³⁴ No single panacea exists for the value improvement of hospitalist programs in California across all hospital types and sites.

Unique trends, however, emerge among each hospital type that could direct future improvements. In addition to all sites requiring increased transparency and access to data, community-based hospitalists identified the need for improvement in the creation of a blame-free environment, comfort with cost conversations, and aspects of leadership and health system messaging. While a high proportion of these hospitalists reported a work culture and role modeling that support the delivery of quality care at low costs, opportunities to create open discussion and frontline involvement in improvement efforts, weigh costs into clinical decision making, and cost conversations with patients exist. We hypothesize that these opportunities exist because community-based hospitals create infrastructure and technology to drive improvement that is often unseen by frontline providers. University-based hospitalists performed higher on three of the four domains compared with their counterparts but may have opportunities to promote a blame-free environment. A great proportion of these hospitalists reported the occurrence of open discussion and active projects within their institutions but also identified opportunities for the improvement of project implementation. Safety-net hospitalists reported the need to improve leadership and health system messaging across most domain items. Further study is required to evaluate reasons for safety-net hospitalists’ responses. We hypothesize that these responses may be related to having limited institutional resources to provide data and coordinated care and different institutional payment models. Each of these sites could identify trends in specific questions identified by the HVCCS for improvement in the high-value care culture.²⁵

Our study evaluated 12 hospitalist programs in California that represent hospitals of different sizes and institutional VBP performance. A large multisite study that evaluates HVCCS across other specialties and disciplines in medicine, all regions of the country, and ambulatory care settings may be conducted in the future. Community-based hospitalist programs also reported low mean HVCCS scores, and further studies could better understand this relationship.

The limitations of the study include its small subgroup sample size and the lack of a gold standard for the measurement of high-value care. As expected, hospitalist groups among safety-net hospitals in California are small, and we may have been underpowered to determine some correlations presented by safety-net sites when stratifying by hospital type. Other correlations also may have been limited by sample size, including differences in HVCCS scores based on reimbursement and hospital type and the correlation between a blame-free environment and reimbursement type. Additionally, the field lacks a gold standard for the measurement of high-value care to help stratify institutional value performance for site selection. The VBP measure presents policy implications and is currently the best available measure with recent value data for over 3,000 hospitals nationally and representing various types of hospitals. This study is also cross-sectional and may benefit from the further evaluation of organizational culture over time and across other settings.

The HVCCS can identify clear targets for improvement and has been evaluated among internal medicine hospitalists. Hospitalists who are paid partly based on productivity reported low measures of high-value care culture at their institutions. As the nation moves toward increasingly value-based payment models, hospitals can strive to improve their understanding of their individual culture for value and begin addressing gaps.

Acknowledgments

The authors wish to thank Michael Lazarus, MD from the University of California Los Angeles; Robert Wachter, MD, James Harrison, PhD; Victoria Valencia, MPH from Dell Medical School at the University of Texas at Austin; Mithu Molla, MD from University of California Davis; Gregory Seymann, MD from the University of California San Diego; Bindu Swaroop, MD and Alpesh Amin, MD from University of California Irvine; Jessica Murphy, DO and Danny Sam, MD from Kaiser Permanente Santa Clara; Thomas Baudendistel, MD and Rajeeva Ranga, MD from Kaiser Permanente Oakland; Yile Ding, MD from California Pacific Medical Center; Soma Wali, MD from Los Angeles County/ OliveView UCLA Medical Center; Anshu Abhat, MD, MPH from the LA BioMed Institute at Los Angeles County/ Harbor-UCLA Medical Center; Steve Tringali, MD from Community Regional Medical Center Fresno; and Dan Dworsky, MD from Scripps Green Hospital for their site leadership and participation with the study.

Disclosures

Dr. Gupta is the Director of the Teaching Value in Healthcare Learning Network at Costs of Care. Dr. Moriates receives royalties from McGraw Hill for the textbook “Understanding Value-based Healthcare” outside of the submitted work and is the Director of Implementation at Costs of Care.

The Centers of Medicare and Medicaid Services (CMS) has introduced new payment models that tie quality and value incentives to 90% of fee-for-service payments and provide 50% of Medicare payments through alternative payment models.¹ The push toward value comes after productivity-based physician reimbursement (ie, fee for service) has been associated with poor quality care, including delayed diagnoses, complications, readmissions, increased length of stay, and high costs of care.^2-5 The method of physician payment is widely believed to affect clinical behavior by incentivizing doing more, coding for more, and billing for more.^6-7 Although payment systems may be used to achieve policy objectives,⁸ little is known about the association of different payment systems with the culture of delivering value-based care among frontline clinicians.

Culture is defined as a system of shared assumptions, values, beliefs, and norms within an environment and has a powerful role in shaping clinician practice patterns.^9-12 The culture within medicine currently contributes to the overuse of resources,^11,13 and a culture for improvement is correlated with clinical outcomes. A systematic review found a consistent association between positive organization culture and improved outcomes including mortality.¹⁴ Across health systems, institutions with high scores on patient safety culture surveys have shown improvements in clinical behaviors and patient outcomes.^15-18

In this study, we aim to describe high-value care culture among internal medicine hospitalists across diverse hospitals and evaluate the relationship between physician reimbursement and high-value care culture.

Study Design

This study is an observational, cross-sectional survey-based study of hospitalists from 12 hospitals in California between January and June 2016.

Study Population

A total of 12 hospitals with hospitalist programs in California were chosen to represent three types of hospitals (ie, four university, four community, and four safety net). Safety-net hospitals, which traditionally serve low-income and medically and socially vulnerable patients were defined as those in the top quartile (ie, greater than 0.5) of their Disproportionate Share Index (DSH), which measures Medicaid patient load.^19-20

To select hospitals with varying value-based care performance, we stratified using CMS value-based purchasing (VBP) scores from fiscal year 2015; these scores have been used to adjust reimbursement for just over 3,000 hospitals in the VBP program of CMS.^22,23 CMS calculates the VBP total performance score as a composite of four domains: (1) clinical processes of care (20% of total performance); (2) patient satisfaction (30%); (3) patient outcomes, including mortality and complications (30%); and (4) cost defined by Medicare payment per beneficiary (20%).²¹ Established quality measures are based on data reported by participating hospitals and chart abstraction during 2011-2014.²² Although other clinical measures of care intensity have been used as proxies of value-based care,^23,24 we used the measure of value that has been publically reported by the CMS VBP given its wide use and effects on reimbursements for 80% of hospitals in the CMS VBP program in 2015.²⁵ We obtained institution-level data from the CMS VBP Program and Hospital Compare files. Each of the three types of hospitals represented institutions with low, middle, and high VBP performance (split in tertiles) as reported by the CMS VBP program. To increase the number of participants in tertiles with fewer hospitalists, a fourth hospital was selected for each hospital type.

We excluded individual hospitalists who primarily identified as working in subspecialty divisions and those who spent less than eight weeks during the last year providing direct patient care on inpatient internal medicine services at the studied institution.

Measurement

Hospitalists were asked to complete the High-Value Care Culture Survey (HVCCS^TM), which measures the culture of value-based decision making among frontline clinicians.²⁶ Similar to other validated surveys for the assessment of patient safety culture,^27,28 the HVCCS can be used to identify target areas for improvement. The survey includes four domains: (1) leadership and health system messaging, (2) data transparency and access, (3) comfort with cost conversations, and (4) blame-free environment. This tool was developed by using a two-phase national modified Delphi process. It was evaluated at two academic centers to complete factor analysis and assess internal consistency, reliability, and validity among internal medicine hospitalists and residents. Validation included estimating product-moment correlation of overall HVCCS scores and domain scores with the CMS institutional VBP scores. HVCCS scores are standardized to a 0-100 point scale for each of the four domains and are then averaged to obtain an overall score.²⁶

In the survey, value was defined as the quality of care provided to patients in relation to the costs required to deliver that care, and high-value care was defined as care that tried to maximize quality while minimizing costs. Quality was defined as the degree to which health services increased the likelihood of desired health outcomes that are safe, effective, patient centered, timely, equitable, and consistent with current professional knowledge. Cost was defined as the negative financial, physical, and emotional effects on patients and the health system.²⁶

Data Analysis

We described the overall institutional mean high-value care culture and domain scores measured by the HVCCS, hospitalist demographics and training experiences, and hospital characteristics. We also described individual survey items. Descriptive statistics were stratified and compared on the basis of hospital type (ie, safety net, community, or university). We assessed the relationship between the clinician perception of reimbursement structure within their divisions and individually reported high-value care culture scores using bivariate and multilevel linear regression. We hypothesized that compared with hospitalists who were paid with salaries or wages, those who reported reimbursement with productivity adjustments may report lower HVCCS scores and those who reported reimbursement with quality or value adjustments may report higher HVCCS scores. We adjusted for physician- and hospital-level characteristics, including age, gender, and training track, and considered hospital type and size as random effects.

This study was approved by the Institutional Review Board at all 12 sites. All analyses were conducted using STATA^® 13.0 (College Station, Texas).

Hospitalist Characteristics

A total of 255 (68.9%, 255/370) hospitalists across all sites completed the survey. Of these respondents, 135 were female (50.6%). On average, hospitalists were 39 years of age (SD 6.8), trained in categorical tracks (221; 86.7%), and had previously trained for 14.3 months at a safety-net hospital (SD 14.2). In total, 166 hospitalists (65.1%) reported being paid with salary or wages, 77 (30.2%) with salary plus productivity adjustments, and 12 (4.7%) with salary plus quality or value adjustments. Moreover, 123 (48.6%) hospitalists agreed that funding for their group depended on the volume of services they delivered. Community-based hospitalists reported higher rates of reimbursement with salary plus productivity (47; 32.0%) compared with their counterparts from university-based (24; 28.2%) and safety-net based programs (6; 26.1%). Among the three different hospital types, significant differences exist in hospitalist mean age (P < .001), gender (P = .01), and the number of months training in a safety-net hospital (P = .02; Table 1).

Hospital Characteristics

Of the 12 study sites, four from each type of hospital (ie, safety-net based, community based, and university based) and four representing each value-based purchasing performance tertile (ie, high, middle, and low) were included. Eleven (91.7%) sites were located in urban areas with an average DSH index of 0.40 (SD 0.23), case mix index of 1.97 (SD 0.28), and bed size of 435.5 (SD 146.0; Table 1).

In multilevel regression modeling across all 12 sites, hospitalists from community-based hospitalist programs reported lower mean HVCCS scores (β = −4.4, 95% CI −8.1 to −0.7; Table 2) than those from other hospital types.

High-Value Care Culture Survey Scores

The mean HVCCS score was 50.2 (SD 13.6), and mean domain scores across all sites were 65.4 (SD 15.6) for leadership and health system messaging, 32.4 (SD 22.8) for data transparency and access, 52.1 (SD 19.7) for comfort with cost conversations, and 50.7 (SD 21.4) for blame-free environment (Table 1). For the majority (two-thirds) of individual HVCCS items, more than 30% of hospitalists across all sites agreed or strongly agreed that components of a low-value care culture exist within their institutions. For example, over 80% of hospitalists reported low transparency and limited access to data (see Appendix I for complete survey responses).

Hospitalists reported different HVCCS domains as strengths or weaknesses within their institutions in accordance with hospital type. Compared with university-based and safety-net-based hospitalists, community-based hospitalists reported lower scores in having a blame-free environment (466, SD 21.8). Nearly 50% reported that the clinicians’ fear of legal repercussions affects their frequency of ordering unneeded tests or procedures, and 30% reported that individual clinicians are blamed for complications. Nearly 40% reported that clinicians are uncomfortable discussing the costs of tests or treatments with patients and reported that clinicians do not feel that physicians should discuss costs with patients. Notably, community-based hospitalists uniquely differed in how they reported components of leadership and health system messaging. Over 60% reported a work climate or role modeling supportive of delivering quality care at lower costs. Only 48%, however, reported success seen from implemented efforts, and 45% reported weighing costs in clinical decision making (Table 1, Appendix I).

University-based hospitalists had significantly higher scores in leadership and health system messaging (67.4, SD 16.9) than community-based and safety-net-based hospitalists. They reported that their institutions consider their suggestions to improve quality care at low cost (75%), openly discuss ways to deliver this care (64%), and are actively implementing projects (73%). However, only 54% reported seeing success from implemented high-value care efforts (Table 1, Appendix I).

Safety-net hospitalists reported lower scores in leadership and health system messaging (56.8, SD 10.5) than university-based and community-based hospitalists. Few hospitalists reported a work climate (26%) or role modeling (30%) that is supportive of delivering quality care at low costs, openly discusses ways to deliver this care (35%), encourages frontline clinicians to pursue improvement projects (57%), or actively implements projects (26%). They also reported higher scores in the blame-free environment domain (59.8, SD 22.3; Table 1; Appendix 1).

Productivity Adjustments and High-Value Care Culture

In multilevel regression modeling, hospitalists who reported reimbursement with salary plus productivity adjustments had a lower mean HVCCS score (β = −6.2, 95% CI −9.9 to –2.5) than those who reported payment with salary or wages alone. Further multilevel regression modeling for each HVCCS domain revealed that hospitalists who reported reimbursement with salary plus productivity adjustments had lower scores in the leadership and health system messaging domain (β = −4.9, 95% CI −9.3 to −0.6) and data transparency and access domain (β = −10.7, 95% CI −16.7 to −4.6). No statistically significant difference was found between hospitalists who reported reimbursement with quality or value adjustments.

Understanding the drivers that are associated with a high-value care culture is necessary as payment models for hospitals transition from volume-based to value-based care. In this study, we found a meaningful association (β = −6.2) between clinician reimbursement schemes and measures of high-value care culture. A six-point change in the HVCCS score would correspond with a hospital moving from the top quartile to the median, which represents a significant change in performance. The relationship between clinician reimbursement schemes and high-value care culture may be a bidirectional relationship. Fee for service, the predominant payment scheme, places pressure on clinicians to maximize volume, focus on billing, and provide reactive care.^7,29 Conversely, payment schemes that avoid these incentives (ie, salary, wages, and adjustments for quality or value), especially if incentives are felt by frontline clinicians, may better align with goals for long-term health outcomes for patient populations and reduce excess visits and services.^2-6,8,30-34 At the same time, hospitals with a strong high-value care culture may be more likely to introduce shared savings programs and alternative payment models than those without. Through these decisions, the leadership can play an important role in creating an environment for change.³⁴ Similar to the study sites, hospitals in California have a higher percentage of risk-based payments than hospitals in other states (>22%)³⁵ and may also provide incentives to promote a high-value care culture or affect local physician compensation models.

Hospitals have options in how they choose to pay their clinicians, and these decisions may have downstream effects, such as building or eroding high-value care culture among clinicians or staff. A dose-response relationship between physician compensation models and value culture is plausible (salary with productivity < salary only < salary with value incentive). However, we did not find a statistically significant difference for salary with value incentive. This result may be attributed to the relatively small sample size in this study.

Hospitals can also improve their internal processes, organizational structure, and align their institutional payment contracts with those that emphasize value over fee-for-service-based incentives to increase value in care delivery.³⁶ The operation of hospitals is challenging when competing payment incentives are used at the same time,⁷ and leadership will likely achieve more success in improving a high-value care culture and value performance when all efforts, including clinician and institutional payment, are aligned.^37-38

Enduring large systems redesign will require directing attention to local organizational culture. For the majority of individual HVCCS items, 30% or more hospitalists across all sites agreed or strongly agreed that components of low-value care culture exist within their institutions. This response demonstrates a lack of focus on culture to address high-value care improvement among the study sites. Division and program leaders can begin measuring culture within their groups to develop new interventions that target culture change and improve value.³⁴ No single panacea exists for the value improvement of hospitalist programs in California across all hospital types and sites.

Unique trends, however, emerge among each hospital type that could direct future improvements. In addition to all sites requiring increased transparency and access to data, community-based hospitalists identified the need for improvement in the creation of a blame-free environment, comfort with cost conversations, and aspects of leadership and health system messaging. While a high proportion of these hospitalists reported a work culture and role modeling that support the delivery of quality care at low costs, opportunities to create open discussion and frontline involvement in improvement efforts, weigh costs into clinical decision making, and cost conversations with patients exist. We hypothesize that these opportunities exist because community-based hospitals create infrastructure and technology to drive improvement that is often unseen by frontline providers. University-based hospitalists performed higher on three of the four domains compared with their counterparts but may have opportunities to promote a blame-free environment. A great proportion of these hospitalists reported the occurrence of open discussion and active projects within their institutions but also identified opportunities for the improvement of project implementation. Safety-net hospitalists reported the need to improve leadership and health system messaging across most domain items. Further study is required to evaluate reasons for safety-net hospitalists’ responses. We hypothesize that these responses may be related to having limited institutional resources to provide data and coordinated care and different institutional payment models. Each of these sites could identify trends in specific questions identified by the HVCCS for improvement in the high-value care culture.²⁵

Our study evaluated 12 hospitalist programs in California that represent hospitals of different sizes and institutional VBP performance. A large multisite study that evaluates HVCCS across other specialties and disciplines in medicine, all regions of the country, and ambulatory care settings may be conducted in the future. Community-based hospitalist programs also reported low mean HVCCS scores, and further studies could better understand this relationship.

The limitations of the study include its small subgroup sample size and the lack of a gold standard for the measurement of high-value care. As expected, hospitalist groups among safety-net hospitals in California are small, and we may have been underpowered to determine some correlations presented by safety-net sites when stratifying by hospital type. Other correlations also may have been limited by sample size, including differences in HVCCS scores based on reimbursement and hospital type and the correlation between a blame-free environment and reimbursement type. Additionally, the field lacks a gold standard for the measurement of high-value care to help stratify institutional value performance for site selection. The VBP measure presents policy implications and is currently the best available measure with recent value data for over 3,000 hospitals nationally and representing various types of hospitals. This study is also cross-sectional and may benefit from the further evaluation of organizational culture over time and across other settings.

The HVCCS can identify clear targets for improvement and has been evaluated among internal medicine hospitalists. Hospitalists who are paid partly based on productivity reported low measures of high-value care culture at their institutions. As the nation moves toward increasingly value-based payment models, hospitals can strive to improve their understanding of their individual culture for value and begin addressing gaps.

Acknowledgments

The authors wish to thank Michael Lazarus, MD from the University of California Los Angeles; Robert Wachter, MD, James Harrison, PhD; Victoria Valencia, MPH from Dell Medical School at the University of Texas at Austin; Mithu Molla, MD from University of California Davis; Gregory Seymann, MD from the University of California San Diego; Bindu Swaroop, MD and Alpesh Amin, MD from University of California Irvine; Jessica Murphy, DO and Danny Sam, MD from Kaiser Permanente Santa Clara; Thomas Baudendistel, MD and Rajeeva Ranga, MD from Kaiser Permanente Oakland; Yile Ding, MD from California Pacific Medical Center; Soma Wali, MD from Los Angeles County/ OliveView UCLA Medical Center; Anshu Abhat, MD, MPH from the LA BioMed Institute at Los Angeles County/ Harbor-UCLA Medical Center; Steve Tringali, MD from Community Regional Medical Center Fresno; and Dan Dworsky, MD from Scripps Green Hospital for their site leadership and participation with the study.

Disclosures

Dr. Gupta is the Director of the Teaching Value in Healthcare Learning Network at Costs of Care. Dr. Moriates receives royalties from McGraw Hill for the textbook “Understanding Value-based Healthcare” outside of the submitted work and is the Director of Implementation at Costs of Care.

The Centers of Medicare and Medicaid Services (CMS) has introduced new payment models that tie quality and value incentives to 90% of fee-for-service payments and provide 50% of Medicare payments through alternative payment models.¹ The push toward value comes after productivity-based physician reimbursement (ie, fee for service) has been associated with poor quality care, including delayed diagnoses, complications, readmissions, increased length of stay, and high costs of care.^2-5 The method of physician payment is widely believed to affect clinical behavior by incentivizing doing more, coding for more, and billing for more.^6-7 Although payment systems may be used to achieve policy objectives,⁸ little is known about the association of different payment systems with the culture of delivering value-based care among frontline clinicians.

Culture is defined as a system of shared assumptions, values, beliefs, and norms within an environment and has a powerful role in shaping clinician practice patterns.^9-12 The culture within medicine currently contributes to the overuse of resources,^11,13 and a culture for improvement is correlated with clinical outcomes. A systematic review found a consistent association between positive organization culture and improved outcomes including mortality.¹⁴ Across health systems, institutions with high scores on patient safety culture surveys have shown improvements in clinical behaviors and patient outcomes.^15-18

In this study, we aim to describe high-value care culture among internal medicine hospitalists across diverse hospitals and evaluate the relationship between physician reimbursement and high-value care culture.

Study Design

This study is an observational, cross-sectional survey-based study of hospitalists from 12 hospitals in California between January and June 2016.

Study Population

A total of 12 hospitals with hospitalist programs in California were chosen to represent three types of hospitals (ie, four university, four community, and four safety net). Safety-net hospitals, which traditionally serve low-income and medically and socially vulnerable patients were defined as those in the top quartile (ie, greater than 0.5) of their Disproportionate Share Index (DSH), which measures Medicaid patient load.^19-20

To select hospitals with varying value-based care performance, we stratified using CMS value-based purchasing (VBP) scores from fiscal year 2015; these scores have been used to adjust reimbursement for just over 3,000 hospitals in the VBP program of CMS.^22,23 CMS calculates the VBP total performance score as a composite of four domains: (1) clinical processes of care (20% of total performance); (2) patient satisfaction (30%); (3) patient outcomes, including mortality and complications (30%); and (4) cost defined by Medicare payment per beneficiary (20%).²¹ Established quality measures are based on data reported by participating hospitals and chart abstraction during 2011-2014.²² Although other clinical measures of care intensity have been used as proxies of value-based care,^23,24 we used the measure of value that has been publically reported by the CMS VBP given its wide use and effects on reimbursements for 80% of hospitals in the CMS VBP program in 2015.²⁵ We obtained institution-level data from the CMS VBP Program and Hospital Compare files. Each of the three types of hospitals represented institutions with low, middle, and high VBP performance (split in tertiles) as reported by the CMS VBP program. To increase the number of participants in tertiles with fewer hospitalists, a fourth hospital was selected for each hospital type.

We excluded individual hospitalists who primarily identified as working in subspecialty divisions and those who spent less than eight weeks during the last year providing direct patient care on inpatient internal medicine services at the studied institution.

Measurement

Hospitalists were asked to complete the High-Value Care Culture Survey (HVCCS^TM), which measures the culture of value-based decision making among frontline clinicians.²⁶ Similar to other validated surveys for the assessment of patient safety culture,^27,28 the HVCCS can be used to identify target areas for improvement. The survey includes four domains: (1) leadership and health system messaging, (2) data transparency and access, (3) comfort with cost conversations, and (4) blame-free environment. This tool was developed by using a two-phase national modified Delphi process. It was evaluated at two academic centers to complete factor analysis and assess internal consistency, reliability, and validity among internal medicine hospitalists and residents. Validation included estimating product-moment correlation of overall HVCCS scores and domain scores with the CMS institutional VBP scores. HVCCS scores are standardized to a 0-100 point scale for each of the four domains and are then averaged to obtain an overall score.²⁶

In the survey, value was defined as the quality of care provided to patients in relation to the costs required to deliver that care, and high-value care was defined as care that tried to maximize quality while minimizing costs. Quality was defined as the degree to which health services increased the likelihood of desired health outcomes that are safe, effective, patient centered, timely, equitable, and consistent with current professional knowledge. Cost was defined as the negative financial, physical, and emotional effects on patients and the health system.²⁶

Data Analysis

We described the overall institutional mean high-value care culture and domain scores measured by the HVCCS, hospitalist demographics and training experiences, and hospital characteristics. We also described individual survey items. Descriptive statistics were stratified and compared on the basis of hospital type (ie, safety net, community, or university). We assessed the relationship between the clinician perception of reimbursement structure within their divisions and individually reported high-value care culture scores using bivariate and multilevel linear regression. We hypothesized that compared with hospitalists who were paid with salaries or wages, those who reported reimbursement with productivity adjustments may report lower HVCCS scores and those who reported reimbursement with quality or value adjustments may report higher HVCCS scores. We adjusted for physician- and hospital-level characteristics, including age, gender, and training track, and considered hospital type and size as random effects.

This study was approved by the Institutional Review Board at all 12 sites. All analyses were conducted using STATA^® 13.0 (College Station, Texas).

Hospitalist Characteristics

A total of 255 (68.9%, 255/370) hospitalists across all sites completed the survey. Of these respondents, 135 were female (50.6%). On average, hospitalists were 39 years of age (SD 6.8), trained in categorical tracks (221; 86.7%), and had previously trained for 14.3 months at a safety-net hospital (SD 14.2). In total, 166 hospitalists (65.1%) reported being paid with salary or wages, 77 (30.2%) with salary plus productivity adjustments, and 12 (4.7%) with salary plus quality or value adjustments. Moreover, 123 (48.6%) hospitalists agreed that funding for their group depended on the volume of services they delivered. Community-based hospitalists reported higher rates of reimbursement with salary plus productivity (47; 32.0%) compared with their counterparts from university-based (24; 28.2%) and safety-net based programs (6; 26.1%). Among the three different hospital types, significant differences exist in hospitalist mean age (P < .001), gender (P = .01), and the number of months training in a safety-net hospital (P = .02; Table 1).

Hospital Characteristics

Of the 12 study sites, four from each type of hospital (ie, safety-net based, community based, and university based) and four representing each value-based purchasing performance tertile (ie, high, middle, and low) were included. Eleven (91.7%) sites were located in urban areas with an average DSH index of 0.40 (SD 0.23), case mix index of 1.97 (SD 0.28), and bed size of 435.5 (SD 146.0; Table 1).

In multilevel regression modeling across all 12 sites, hospitalists from community-based hospitalist programs reported lower mean HVCCS scores (β = −4.4, 95% CI −8.1 to −0.7; Table 2) than those from other hospital types.

High-Value Care Culture Survey Scores

The mean HVCCS score was 50.2 (SD 13.6), and mean domain scores across all sites were 65.4 (SD 15.6) for leadership and health system messaging, 32.4 (SD 22.8) for data transparency and access, 52.1 (SD 19.7) for comfort with cost conversations, and 50.7 (SD 21.4) for blame-free environment (Table 1). For the majority (two-thirds) of individual HVCCS items, more than 30% of hospitalists across all sites agreed or strongly agreed that components of a low-value care culture exist within their institutions. For example, over 80% of hospitalists reported low transparency and limited access to data (see Appendix I for complete survey responses).

Hospitalists reported different HVCCS domains as strengths or weaknesses within their institutions in accordance with hospital type. Compared with university-based and safety-net-based hospitalists, community-based hospitalists reported lower scores in having a blame-free environment (466, SD 21.8). Nearly 50% reported that the clinicians’ fear of legal repercussions affects their frequency of ordering unneeded tests or procedures, and 30% reported that individual clinicians are blamed for complications. Nearly 40% reported that clinicians are uncomfortable discussing the costs of tests or treatments with patients and reported that clinicians do not feel that physicians should discuss costs with patients. Notably, community-based hospitalists uniquely differed in how they reported components of leadership and health system messaging. Over 60% reported a work climate or role modeling supportive of delivering quality care at lower costs. Only 48%, however, reported success seen from implemented efforts, and 45% reported weighing costs in clinical decision making (Table 1, Appendix I).

University-based hospitalists had significantly higher scores in leadership and health system messaging (67.4, SD 16.9) than community-based and safety-net-based hospitalists. They reported that their institutions consider their suggestions to improve quality care at low cost (75%), openly discuss ways to deliver this care (64%), and are actively implementing projects (73%). However, only 54% reported seeing success from implemented high-value care efforts (Table 1, Appendix I).

Safety-net hospitalists reported lower scores in leadership and health system messaging (56.8, SD 10.5) than university-based and community-based hospitalists. Few hospitalists reported a work climate (26%) or role modeling (30%) that is supportive of delivering quality care at low costs, openly discusses ways to deliver this care (35%), encourages frontline clinicians to pursue improvement projects (57%), or actively implements projects (26%). They also reported higher scores in the blame-free environment domain (59.8, SD 22.3; Table 1; Appendix 1).

Productivity Adjustments and High-Value Care Culture

In multilevel regression modeling, hospitalists who reported reimbursement with salary plus productivity adjustments had a lower mean HVCCS score (β = −6.2, 95% CI −9.9 to –2.5) than those who reported payment with salary or wages alone. Further multilevel regression modeling for each HVCCS domain revealed that hospitalists who reported reimbursement with salary plus productivity adjustments had lower scores in the leadership and health system messaging domain (β = −4.9, 95% CI −9.3 to −0.6) and data transparency and access domain (β = −10.7, 95% CI −16.7 to −4.6). No statistically significant difference was found between hospitalists who reported reimbursement with quality or value adjustments.

Understanding the drivers that are associated with a high-value care culture is necessary as payment models for hospitals transition from volume-based to value-based care. In this study, we found a meaningful association (β = −6.2) between clinician reimbursement schemes and measures of high-value care culture. A six-point change in the HVCCS score would correspond with a hospital moving from the top quartile to the median, which represents a significant change in performance. The relationship between clinician reimbursement schemes and high-value care culture may be a bidirectional relationship. Fee for service, the predominant payment scheme, places pressure on clinicians to maximize volume, focus on billing, and provide reactive care.^7,29 Conversely, payment schemes that avoid these incentives (ie, salary, wages, and adjustments for quality or value), especially if incentives are felt by frontline clinicians, may better align with goals for long-term health outcomes for patient populations and reduce excess visits and services.^2-6,8,30-34 At the same time, hospitals with a strong high-value care culture may be more likely to introduce shared savings programs and alternative payment models than those without. Through these decisions, the leadership can play an important role in creating an environment for change.³⁴ Similar to the study sites, hospitals in California have a higher percentage of risk-based payments than hospitals in other states (>22%)³⁵ and may also provide incentives to promote a high-value care culture or affect local physician compensation models.

Hospitals have options in how they choose to pay their clinicians, and these decisions may have downstream effects, such as building or eroding high-value care culture among clinicians or staff. A dose-response relationship between physician compensation models and value culture is plausible (salary with productivity < salary only < salary with value incentive). However, we did not find a statistically significant difference for salary with value incentive. This result may be attributed to the relatively small sample size in this study.

Hospitals can also improve their internal processes, organizational structure, and align their institutional payment contracts with those that emphasize value over fee-for-service-based incentives to increase value in care delivery.³⁶ The operation of hospitals is challenging when competing payment incentives are used at the same time,⁷ and leadership will likely achieve more success in improving a high-value care culture and value performance when all efforts, including clinician and institutional payment, are aligned.^37-38

Enduring large systems redesign will require directing attention to local organizational culture. For the majority of individual HVCCS items, 30% or more hospitalists across all sites agreed or strongly agreed that components of low-value care culture exist within their institutions. This response demonstrates a lack of focus on culture to address high-value care improvement among the study sites. Division and program leaders can begin measuring culture within their groups to develop new interventions that target culture change and improve value.³⁴ No single panacea exists for the value improvement of hospitalist programs in California across all hospital types and sites.

Unique trends, however, emerge among each hospital type that could direct future improvements. In addition to all sites requiring increased transparency and access to data, community-based hospitalists identified the need for improvement in the creation of a blame-free environment, comfort with cost conversations, and aspects of leadership and health system messaging. While a high proportion of these hospitalists reported a work culture and role modeling that support the delivery of quality care at low costs, opportunities to create open discussion and frontline involvement in improvement efforts, weigh costs into clinical decision making, and cost conversations with patients exist. We hypothesize that these opportunities exist because community-based hospitals create infrastructure and technology to drive improvement that is often unseen by frontline providers. University-based hospitalists performed higher on three of the four domains compared with their counterparts but may have opportunities to promote a blame-free environment. A great proportion of these hospitalists reported the occurrence of open discussion and active projects within their institutions but also identified opportunities for the improvement of project implementation. Safety-net hospitalists reported the need to improve leadership and health system messaging across most domain items. Further study is required to evaluate reasons for safety-net hospitalists’ responses. We hypothesize that these responses may be related to having limited institutional resources to provide data and coordinated care and different institutional payment models. Each of these sites could identify trends in specific questions identified by the HVCCS for improvement in the high-value care culture.²⁵

Our study evaluated 12 hospitalist programs in California that represent hospitals of different sizes and institutional VBP performance. A large multisite study that evaluates HVCCS across other specialties and disciplines in medicine, all regions of the country, and ambulatory care settings may be conducted in the future. Community-based hospitalist programs also reported low mean HVCCS scores, and further studies could better understand this relationship.

The limitations of the study include its small subgroup sample size and the lack of a gold standard for the measurement of high-value care. As expected, hospitalist groups among safety-net hospitals in California are small, and we may have been underpowered to determine some correlations presented by safety-net sites when stratifying by hospital type. Other correlations also may have been limited by sample size, including differences in HVCCS scores based on reimbursement and hospital type and the correlation between a blame-free environment and reimbursement type. Additionally, the field lacks a gold standard for the measurement of high-value care to help stratify institutional value performance for site selection. The VBP measure presents policy implications and is currently the best available measure with recent value data for over 3,000 hospitals nationally and representing various types of hospitals. This study is also cross-sectional and may benefit from the further evaluation of organizational culture over time and across other settings.

The HVCCS can identify clear targets for improvement and has been evaluated among internal medicine hospitalists. Hospitalists who are paid partly based on productivity reported low measures of high-value care culture at their institutions. As the nation moves toward increasingly value-based payment models, hospitals can strive to improve their understanding of their individual culture for value and begin addressing gaps.

Acknowledgments

The authors wish to thank Michael Lazarus, MD from the University of California Los Angeles; Robert Wachter, MD, James Harrison, PhD; Victoria Valencia, MPH from Dell Medical School at the University of Texas at Austin; Mithu Molla, MD from University of California Davis; Gregory Seymann, MD from the University of California San Diego; Bindu Swaroop, MD and Alpesh Amin, MD from University of California Irvine; Jessica Murphy, DO and Danny Sam, MD from Kaiser Permanente Santa Clara; Thomas Baudendistel, MD and Rajeeva Ranga, MD from Kaiser Permanente Oakland; Yile Ding, MD from California Pacific Medical Center; Soma Wali, MD from Los Angeles County/ OliveView UCLA Medical Center; Anshu Abhat, MD, MPH from the LA BioMed Institute at Los Angeles County/ Harbor-UCLA Medical Center; Steve Tringali, MD from Community Regional Medical Center Fresno; and Dan Dworsky, MD from Scripps Green Hospital for their site leadership and participation with the study.

Disclosures

Dr. Gupta is the Director of the Teaching Value in Healthcare Learning Network at Costs of Care. Dr. Moriates receives royalties from McGraw Hill for the textbook “Understanding Value-based Healthcare” outside of the submitted work and is the Director of Implementation at Costs of Care.