Digital Engagement Strategy and Health Care Worker Mental Health: A Randomized Clinical Trial.

Importance: The health care workforce continues to experience high rates of depression and anxiety. Finding ways to effectively support the mental health and well-being of health care workers is challenging. Objective: To test the effectiveness of remote, pushed digital assessments and engagement to improve depression and anxiety among health care workers compared with usual care. Design, Setting, and Participants: This was a 9-month randomized clinical trial with a 6-month intervention period. Participants were health care workers with self-reported daily access to a smartphone and at least 4 clinical hours per week. Participants were randomized to usual care or the intervention between January 2022 and March 2023. Data analyses were conducted between May and July 2023. Interventions: All participants completed baseline, 6-month, and 9-month mental health, well-being, and burnout assessments. The control group had open access to a web-based mental health platform. Participants in the intervention group received monthly text messaging about mental health, mental health assessments, and linkages to care. Main Outcomes and Measures: The primary outcomes were mean change in depression and anxiety scores at 6 months from baseline. Secondary outcomes include mean change in well-being, burnout, and self-reported workplace productivity. Results: In this study, 1275 participants were randomized (642 [50.4%] to the intervention group and 633 [49.6%] to control group). Participants had a mean (SD) age of 38.6 (10.9) years, 1063 participants (83.4%) were female, 320 (25.1%) self-identified as Black, and 793 (62.2%) self-identified as White. Across the groups, the mean difference in depression score was significantly different at 6 months (-0.96 [95% CI, -1.52 to -0.40]) and at 9 months (-1.14 [95% CI, -1.69 to -0.58]). The mean difference in anxiety score from baseline to 6 months was statistically significantly larger for those in the intervention group vs usual care (-0.71 [95% CI, -1.25 to -0.17]) and held true at 9 months (-1.06 [95% CI, -1.59 to -0.52]). Conclusions and Relevance: In a trial of health care workers, a proactive digital engagement strategy, including pushed text messaging, mobile mental health assessments, and connection to care, improved depression and anxiety over a 6-month period compared with simply making the same resources available for individuals to find and use. Trial Registration: ClinicalTrials.gov Identifier: NCT05028075.

Implementing a resilience coach program to support first year housestaff during the COVID-19 pandemic: early pilot results and comparison with non-housestaff sessions.

BACKGROUND: In response to the COVID-19 pandemic, we launched the Penn Medicine Coping First Aid program to provide psychosocial supports to our health system community. Our approach leveraged lay health worker volunteers trained in principles of Psychological First Aid to deliver coaching services through a centralized virtual platform. METHODS: We emailed all (n = 408) first year housestaff (i.e., residents and fellows) with an invitation to schedule a session with a resilience coach. We compared the mental health concerns, symptoms, and Psychological First Aid techniques recorded in (n = 67) first year housestaff sessions with (n = 91) sessions of other employees in the health system. RESULTS: Between June and November 2020, forty-six first year housestaff attended at least one resilience coaching session. First year housestaff most commonly presented with feelings of anxiety and sadness and shared concerns related to the availability of social support. Resilience coaches most frequently provided practical assistance and ensured safety and comfort to first year housestaff. First year housestaff reported fewer physical or mental health symptoms and held shorter sessions with resilience coaches than non-housestaff. CONCLUSIONS: This work offers insights on how to address psychosocial functioning through low-intensity interventions delivered by lay personnel. More research is needed to understand the efficacy of this program and how best to engage housestaff in wellness and resilience programs throughout training, both during and beyond COVID-19.

Using poetry to elicit internal medicine residents' perspectives on wellness.

PURPOSE: To elicit internal medicine residents' perspectives on wellness through poetry writing, examining (1) response rates, (2) the tone/sentiment of their submissions and (3) the primary thematic content. STUDY DESIGN: In academic year 2019-2020, a random sample of 88 residents from four internal medicine residency programmes was invited to participate in a year-long study of wellness. In December 2019, an open-ended prompt asked residents to write a poem reflecting on their well-being. Responses were inductively coded using content analysis techniques. RESULTS: The response rate for the poetry prompt was 94%. The tone of the entries was most often neutral or contradictory (42%), followed by negative (33%) and positive (25%). There were three main themes: (1) Mindsets: most residents simply wanted to make it through their programme; (2) wellness influencers: the main wellness supporters were external to the programme such as vacationing and exercise; within hospitals, friendships with colleagues and boosted wellness and (3) scheduling/repetition: difficult schedules drained energy as did the monotony of administrative tasks. CONCLUSIONS: Poetry appears to be an innovative and effective vehicle to elicit residents' perspectives without compromising response rate. Poetry survey techniques allow medical trainees to provide powerful messaging to leadership. Most of what is known about trainee wellness is derived from quantitative surveys. This study showed medicine trainees' willingness to engage in poetry and add richness and personal detail to highlight key drivers of wellness. Such information provides context and brings attention in a compelling manner to an important topic.

An Assessment of Faculty Perceptions of Wellness Needs and Strategies to Optimize Engagement With Wellness Resources in Academic Medicine.

OBJECTIVE: Faculty at academic medical institutions are at increased risk for burnout. This study aimed to assess faculty perceptions of wellness needs and identify strategies to optimize engagement with individualized wellness resources. METHODS: Semistructured interviews were conducted with 37 faculty members in one US academic medical center. RESULTS: Participants identified significant barriers to achieving emotional health and wellness goals. Areas where participants identified needing the most support included interpersonal relationships, accountability for wellness goals, career support, financial resources, and mentorship. Most participants were unaware of all wellness resources available at their institution. Participants recommended regular marketing and emphasizing confidentiality of employer-sponsored programs. They also provided feedback on specific dissemination and marketing methods. CONCLUSIONS: This research underscores the need for wellness resources for faculty and the importance of intentional dissemination of these resources to optimize uptake.

COBALT: Supporting the mental well-being of the health care workforce with technology-facilitated care during Covid-19 and beyond.

Two-thirds of health professionals facing the clinical demands of responding to the Covid-19 pandemic experience psychiatric symptoms, including post-traumatic stress, anxiety, substance use, depression, insomnia, and suicide.1,2 Compounding matters, access to mental health services is poor, quality is variable, and stigma is prevalent. COBALT, a digital mental health and wellness platform developed at Penn Medicine, was designed to support health care workers, offering a combination of self-directed resources, virtual group sessions, and individual appointments with a stepped care model of providers, including peers, resilience coaches, psychotherapists, and psychiatrists. In COBALT's first 11 months, the platform saw approximately 10,000 users, 200,000 page views, 1,400 one-on-one appointment bookings, over 1,000 group appointment reservations, and 158 interceptions of employees contemplating self-harm. COBALT reveals the unmet demand for mental health support among health professionals and provides a model for both expanding the supply of and streamlining access to services.

An innovation tournament to improve medical residency.

Two large national studies of resident duty hours incidentally revealed surgical and medical resident dissatisfaction with residency training. Aiming for an inclusive and democratic approach to improve graduate medical education, we conducted a national innovation tournament--reaching out to the program directors of all 474 US internal medicine residency programs to invite them and their residents and associate program directors to participate. Participants could submit multiple ideas as individuals or teams in four domains: [1] resident well-being and personal and professional development; [2] resident education and clinical preparedness; [3] resident sleep and alertness; and [4] patient safety. Residents and program directors were reinvited to rate ideas, whether they had submitted ideas themselves or not. We used a schedule of lottery-based prizes to stimulate the submission and rating of ideas and encourage engagement. 164 residents and program directors from 51 different programs submitted 328 ideas. 153 residents and program directors from 48 different programs submitted 15,345 ratings of ideas. Winning ideas aimed to reduce residents' work burden or improve their mental health, sleep, eating, or relaxation or reflected technical fixes to the operations of residency, such as changing vacation schedules and the timing of pay. The results of this tournament provided actionable suggestions to improve residency training now being tested in our own residency programs. Innovation tournaments drive engagement and generate value by their opportunities for inclusion and by shifting problem solving to the end user.

Exploring Residents' Well-Being and Burnout via Qualitative Ecological Momentary Assessment.

PURPOSE: Most of what is known about resident burnout and wellness comes from cross-sectional snapshot surveys. The purpose of this study was to elicit qualitative perspectives on wellness from a cohort of internal residents over time using ecological momentary assessment. METHOD: Drawing on principles of ecological momentary assessment, 13 different open-ended survey prompts were delivered between October and March during the 2019-2020 academic year. Participants were 88 randomly selected internal medicine residents from 4 internal medicine training programs in the Northeast. RESULTS: The response rate was 95%. Three main themes regarding wellness were self, program/education environment, and medical/structural system. A fourth theme, the desire to provide quality patient care, cut across all other themes. The patient care theme repeatedly stressed residents' desire to spend more time with patients. The self theme primarily reflected messages about personal emotions and the need for work-life balance and wellness. The program/education environment theme reflected the value of learning, teamwork and community, and program culture. The medical/structural system theme showed that residents' experiences were shaped by the efficiency of their days and largely a product of their schedules and administrative support. Closing advice to future trainees was optimistic and reassuring. CONCLUSIONS: While findings support much of what has been learned via single-occasion survey snapshots, an ecological momentary assessment design allowed a deeper dive into contextual associations. The results affirm the primacy of patient care and also highlight the value of teamwork and culture. Peers and program leaders are heavily influential in setting the tone for the learning experience, whether for the day or with a more enduring message of respect and support. There is opportunity to maximize high- or higher-value learning experiences for residents and find solutions to reduce and reframe the perceived "low-value administrative work" that is part of care coordination.

Increasing access to mental health supports for healthcare workers during the COVID-19 pandemic and beyond through a novel coaching program.

The COVID-19 pandemic led to heightened anxiety, distress, and burnout among healthcare workers and faculty in academic medicine. Penn Medicine launched Coping First Aid (CFA) in March 2020 in response to the pandemic. Informed by Psychological First Aid principles and therapeutic micro skills, CFA was designed as a tele-mental healthcare service for health system employees and their families delivered by trained lay volunteer coaches under the supervision of licensed mental health clinicians. We present an overview of the model, feasibility and utilization data, and preliminary implementation and effectiveness outcomes based on cross sectional coach (n = 22) and client (n = 57) self-report surveys with a subset of program users in the first year. A total of 44 individuals completed training and were certified to coach. Over the first 24 months of the program, 513 sessions occurred with 273 clients (119 sessions were no-shows or canceled). Follow-up appointments were recommended in 52.6% (n = 270) of sessions and 21.2% (n = 109) of clients were referred for professional mental health care. Client survey respondents reported CFA was helpful; 60% were very or extremely satisfied, and 74% indicated they would recommend the program. Our preliminary findings suggest that CFA was feasible to implement and most clients found the service beneficial. CFA provides a model for rapidly developing and scaling mental health supports during and beyond the pandemic.

Sleep and Alertness Among Interns in Intensive Care Compared to General Medicine Rotations: A Secondary Analysis of the iCOMPARE Trial.

BACKGROUND: Medical interns are at risk for sleep deprivation from long and often rotating work schedules. However, the effects of specific rotations on sleep are less clear. OBJECTIVE: To examine differences in sleep duration and alertness among internal medicine interns during inpatient intensive care unit (ICU) compared to general medicine (GM) rotations. METHODS: This secondary analysis compared interns during a GM or ICU rotation from a randomized trial (2015-2016) of 12 internal medicine residency programs assigned to different work hour limit policies (standard 16-hour shifts or no shift-length limits). The primary outcome was sleep duration/24-hour using continuous wrist actigraphy over a 13-day period. Secondary outcomes assessed each morning during the concomitant actigraphy period were sleepiness (Karolinska Sleepiness Scale [KSS]), alertness (number of Brief Psychomotor Vigilance Test [PVT-B] lapses), and self-report of excessive sleepiness over past 24 hours. Linear mixed-effect models with random program intercept determined associations between each outcome by rotation, controlling for age, sex, and work hour policy followed. RESULTS: Of 398 interns, 386 were included (n = 261 GM, n = 125 ICU). Average sleep duration was 7.00±0.08h and 6.84±0.10h, and number of PVT lapses were 5.5±0.5 and 5.7±0.7 for GM and ICU, respectively (all P > .05). KSS was 4.8±0.1 for both rotations. Compared to GM, ICU interns reported more days of excessive sleepiness from 12am-6am (2.6 vs 1.7, P < .001) and 6am-12pm (2.6 vs 1.9, P = .013) and had higher percent of days with sleep duration < 6 hours (27.6% vs 23.4%, P < .001). GM interns reported more days with no excessive sleepiness (5.3 vs 3.7, P < .001). CONCLUSIONS: Despite ICU interns reporting more excessive sleepiness in morning hours and more days of insufficient sleep (<6 hours), overall sleep duration and alertness did not significantly differ between rotations.

Dark Clouds With Silver Linings: Resident Anxieties About COVID-19 Coupled With Program Innovations and Increased Resident Well-Being.

BACKGROUND: The COVID-19 pandemic forced numerous unprecedented systemic changes within residency programs and hospital systems. OBJECTIVE: We explored how the COVID-19 pandemic, and associated changes in clinical and educational experiences, were related to internal medicine residents' well-being in the early months of the pandemic. METHODS: Across 4 internal medicine residency programs in the Northeast United States that have previously participated in the iCOMPARE study, all 394 residents were invited to participate in a study with open-ended survey prompts about well-being approximately every 2 weeks in academic year 2019-2020. In March and April 2020, survey prompts were refocused to COVID-19. Content analysis revealed themes in residents' open-ended responses to 4 prompts. RESULTS: One hundred and eighty-six residents expressed interest, and 88 were randomly selected (47%). There were 4 main themes: (1) in early days of the pandemic, internal medicine residents reported fear and anxiety about uncertainty and lack of personal protective equipment; (2) residents adapted and soon were able to reflect, rest, and pursue personal wellness; (3) communication from programs and health systems was inconsistent early in the pandemic but improved in clarity and frequency; (4) residents appreciated the changes programs had made, including shorter shifts, removal of pre-rounding, and telemedicine. CONCLUSIONS: COVID-19 introduced many challenges to internal medicine residency programs and to resident well-being. Programs made structural changes to clinical schedules, educational/conference options, and communication that boosted resident well-being. Many residents hoped these changes would continue regardless of the pandemic's course.

The Definition of Faculty Must Evolve: A Call to Action.

As academic medical centers and academic health centers continue to adapt to the changing landscape of medicine in the United States, the definition of what it means to be faculty must evolve as well. Both institutional economic priorities and the need to recalibrate educational programs to address current and future societal and patient needs have brought new complexity to faculty identity, faculty value, and the educational mission.The Council of Faculty and Academic Societies, 1 of 3 membership councils of the Association of American Medical Colleges (AAMC), established working groups in 2014 to provide a strong voice for academic faculty within the AAMC governance and leadership structures. The Faculty Identity and Value Working Group was charged with identifying the attributes and qualities of future academic medicine faculty in light of the transformational changes occurring at many medical schools and teaching hospitals. The working group developed a framework that could be applied throughout the United States by AAMC member schools to define and value teaching activities. This report adds to the work of others by offering a contemporary construct that is flexible and easily adaptable to enable fair and transparent implementation of an education value system; it is especially relevant for systems in which mergers and acquisitions lead to a large number of clinicians. An example of such an implementation at a large and growing academic medical center is provided.The ability to identify and quantify educational effort by faculty could be transformative by highlighting the fundamental importance of faculty to the development of the future medical workforce.

Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations.

Importance: The United States spends more than $12 billion annually on graduate medical education. Understanding how residents balance patient care and educational activities may provide insights into how the modern physician workforce is being trained. Objective: To describe how first-year internal medicine residents (interns) allocate time while working on general medicine inpatient services. Design, Setting, and Participants: Direct observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region, of the Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, a cluster-randomized trial comparing different duty-hour policies. A total of 194 weekday shifts were observed and time motion data were collected, sampled by daytime, nighttime, and call shifts in proportion to the distribution of shifts within each program from March 10 through May 31, 2016. Data were analyzed from June 1, 2016, through January 5, 2019. Main Outcomes and Measures: Mean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night). Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care were tracked. Results: A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours. A mean (SD) of 15.9 (0.7) hours of a 24-hour period (66%) was spent in indirect patient care, mostly interactions with the patient's medical record or documentation (mean [SD], 10.3 [0.7] hours; 43%). A mean (SD) of 3.0 (0.1) hours was spent in direct patient care (13%) and 1.8 (0.3) hours in education (7%). This pattern was consistent across the 4 periods of the day. Direct patient care and education frequently occurred when interns were performing indirect patient care. Multitasking with 2 or more indirect patient care activities occurred for a mean (SD) of 3.8 (0.4) hours (16%) of the day. Conclusions and Relevance: This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities. These findings provide an essential baseline measure for future efforts designed to improve the workday structure and experience of internal medicine trainees, without making a judgment on the current allocation of time. Trial Registration: ClinicalTrials.gov identifier: NCT02274818.

Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules.

BACKGROUND: Concern persists that extended shifts in medical residency programs may adversely affect patient safety. METHODS: We conducted a cluster-randomized noninferiority trial in 63 internal-medicine residency programs during the 2015-2016 academic year. Programs underwent randomization to a group with standard duty hours, as adopted by the Accreditation Council for Graduate Medical Education (ACGME) in July 2011, or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts. The primary outcome for each program was the change in unadjusted 30-day mortality from the pretrial year to the trial year, as ascertained from Medicare claims. We hypothesized that the change in 30-day mortality in the flexible programs would not be worse than the change in the standard programs (difference-in-difference analysis) by more than 1 percentage point (noninferiority margin). Secondary outcomes were changes in five other patient safety measures and risk-adjusted outcomes for all measures. RESULTS: The change in 30-day mortality (primary outcome) among the patients in the flexible programs (12.5% in the trial year vs. 12.6% in the pretrial year) was noninferior to that in the standard programs (12.2% in the trial year vs. 12.7% in the pretrial year). The test for noninferiority was significant (P = 0.03), with an estimate of the upper limit of the one-sided 95% confidence interval (0.93%) for a between-group difference in the change in mortality that was less than the prespecified noninferiority margin of 1 percentage point. Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also below 1 percentage point; the noninferiority criterion was not met for 30-day readmissions or prolonged length of hospital stay. Risk-adjusted measures generally showed similar findings. CONCLUSIONS: Allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety. (Funded by the National Heart, Lung, and Blood Institute and Accreditation Council for Graduate Medical Education; iCOMPARE ClinicalTrials.gov number, NCT02274818.).

Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine.

BACKGROUND: A purpose of duty-hour regulations is to reduce sleep deprivation in medical trainees, but their effects on sleep, sleepiness, and alertness are largely unknown. METHODS: We randomly assigned 63 internal-medicine residency programs in the United States to follow either standard 2011 duty-hour policies or flexible policies that maintained an 80-hour workweek without limits on shift length or mandatory time off between shifts. Sleep duration and morning sleepiness and alertness were compared between the two groups by means of a noninferiority design, with outcome measures including sleep duration measured with actigraphy, the Karolinska Sleepiness Scale (with scores ranging from 1 [extremely alert] to 9 [extremely sleepy, fighting sleep]), and a brief computerized Psychomotor Vigilance Test (PVT-B), with long response times (lapses) indicating reduced alertness. RESULTS: Data were obtained over a period of 14 days for 205 interns at six flexible programs and 193 interns at six standard programs. The average sleep time per 24 hours was 6.85 hours (95% confidence interval [CI], 6.61 to 7.10) among those in flexible programs and 7.03 hours (95% CI, 6.78 to 7.27) among those in standard programs. Sleep duration in flexible programs was noninferior to that in standard programs (between-group difference, -0.17 hours per 24 hours; one-sided lower limit of the 95% confidence interval, -0.45 hours; noninferiority margin, -0.5 hours; P = 0.02 for noninferiority), as was the score on the Karolinska Sleepiness Scale (between-group difference, 0.12 points; one-sided upper limit of the 95% confidence interval, 0.31 points; noninferiority margin, 1 point; P<0.001). Noninferiority was not established for alertness according to the PVT-B (between-group difference, -0.3 lapses; one-sided upper limit of the 95% confidence interval, 1.6 lapses; noninferiority margin, 1 lapse; P = 0.10). CONCLUSIONS: This noninferiority trial showed no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. Noninferiority of the flexible group for alertness was not established. (Funded by the National Heart, Lung, and Blood Institute and American Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02274818.).

Providing Compassionate Off-Ramps for Medical Students Is a Moral Imperative.

It is highly unusual for learners to leave medical training in the United States even though some individuals' goals may change and others may not achieve expected competence. There are a number of possible reasons for this: (1) Students may feel that they have progressed too far into their careers and amassed too much debt to leave medical training; (2) students may be allowed to graduate despite marginal performance; and (3) students may have entered medical training with risk factors for poor performance that were not addressed. As stewards of the educational process, medical educators have an ethical obligation to students and the public to create off-ramps, or points along the educational continuum at which learners can reassess their goals and educators can assess competence, that allow students to leave medicine.Given the nationwide focus on physician health and wellness, the authors believe the creation of options to leave medical training without compromising one's self-esteem or incurring unmanageable debt (i.e., compassionate off-ramps) is a moral imperative. The practice of medicine should not be an exercise in survival; it should allow people to develop and thrive over the course of their careers. Offering students options to make use of the medical competencies they have accumulated in other attractive careers would enable medical educators to behave compassionately toward individual students and fulfill their societal obligation to graduate competent and committed physicians. To this end, the authors present six recommendations for consideration.

Lactation Space Experiences and Preferences Among Health Care Workers in an Academic Medical Center.

BACKGROUND: Comprehensive workplace lactation support programs can reduce the risk for early breastfeeding discontinuation; however, scant evidence is available to inform user-centered design of employee lactation spaces. This study describes health care workers' preferences for lactation space. MATERIALS AND METHODS: In 2016-2017, a convenience sample of 151 women who pumped at work at an academic medical center reported on demographics, lactation experiences, and room and equipment preferences through an online survey. RESULTS: Respondents worked in research and administration (32%), were nurses (30%), physicians and medical students (19%), or allied health or clinical support staff (19%). Seventy percent had ever used one of the hospital's dedicated lactation spaces. Forty-nine percent ranked hospital-grade pumps the most important piece of lactation room equipment; 83% preferred multiple occupancy lactation suites; and the average maximum acceptable distance to lactation space was 5.6 minutes. CONCLUSIONS: Optimal lactation infrastructure supports the immediate and long-term health of female workers and their children. User needs and preferences can guide design of lactation space to ensure a minimum standard for design, equipment, and distance. Workers may have different preferences depending on roles and experiences; thus, a variety of solutions may be most effective.

Development of the individualised Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial: a protocol summary of a national cluster-randomised trial of resident duty hour policies in internal medicine.

INTRODUCTION: Medical trainees' duty hours have received attention globally; restrictions in Europe, New Zealand and some Canadian provinces are much lower than the 80 hours per week enforced in USA. In USA, resident duty hours have been implemented without evidence simultaneously reflecting competing concerns about patient safety and physician education. The objective is to prospectively evaluate the implications of alternative resident duty hour rules for patient safety, trainee education and intern sleep and alertness. METHODS AND ANALYSIS: 63 US internal medicine training programmes were randomly assigned 1:1 to the 2011 Accreditation Council for Graduate Medical Education resident duty hour rules or to rules more flexible in intern shift length and number of hours off between shifts for academic year 2015-2016. The primary outcome is calculated for each programme as the difference in 30-day mortality rate among Medicare beneficiaries with any of several prespecified principal diagnoses in the intervention year minus 30-day mortality in the preintervention year among Medicare beneficiaries with any of several prespecified principal diagnoses. Additional safety outcomes include readmission rates, prolonged length of stay and costs. Measures derived from trainees' and faculty responses to surveys and from time-motion studies of interns compare the educational experiences of residents. Measures derived from wrist actigraphy, subjective ratings and psychomotor vigilance testing compare the sleep and alertness of interns. Differences between duty hour groups in outcomes will be assessed by intention-to-treat analyses. ETHICS AND DISSEMINATION: The University of Pennsylvania Institutional Review Board (IRB) approved the protocol and served as the IRB of record for 40 programmes that agreed to sign an Institutional Affiliation Agreement. Twenty-three programmes opted for a local review process. TRIAL REGISTRATION NUMBER: NCT02274818; Pre-results.