Development of the Illinois Surgical Quality Improvement Collaborative (ISQIC): Implementing 21 Components to Catalyze Statewide Improvement in Surgical Care.

INTRODUCTION: In 2014, 56 Illinois hospitals came together to form a unique learning collaborative, the Illinois Surgical Quality Improvement Collaborative (ISQIC). Our objectives are to provide an overview of the first three years of ISQIC focused on (1) how the collaborative was formed and funded, (2) the 21 strategies implemented to support quality improvement (QI), (3) collaborative sustainment, and (4) how the collaborative acts as a platform for innovative QI research. METHODS: ISQIC includes 21 components to facilitate QI that target the hospital, the surgical QI team, and the peri-operative microsystem. The components were developed from available evidence, a detailed needs assessment of the hospitals, reviewing experiences from prior surgical and non-surgical QI Collaboratives, and interviews with QI experts. The components comprise 5 domains: guided implementation (e.g., mentors, coaches, statewide QI projects), education (e.g., process improvement (PI) curriculum), hospital- and surgeon-level comparative performance reports (e.g., process, outcomes, costs), networking (e.g., forums to share QI experiences and best practices), and funding (e.g., for the overall program, pilot grants, and bonus payments for improvement). RESULTS: Through implementation of the 21 novel ISQIC components, hospitals were equipped to use their data to successfully implement QI initiatives and improve care. Formal (QI/PI) training, mentoring, and coaching were undertaken by the hospitals as they worked to implement solutions. Hospitals received funding for the program and were able to work together on statewide quality initiatives. Lessons learned at one hospital were shared with all participating hospitals through conferences, webinars, and toolkits to facilitate learning from each other with a common goal of making care better and safer for the surgical patient in Illinois. Over the first three years, surgical outcomes improved in Illinois. DISCUSSION: The first three years of ISQIC improved care for surgical patients across Illinois and allowed hospitals to see the value of participating in a surgical QI learning collaborative without having to make the initial financial investment themselves. Given the strong support and buy-in from the hospitals, ISQIC has continued beyond the initial three years and continues to support QI across Illinois hospitals.

Changes in Surgical Outcomes in a Statewide Quality Improvement Collaborative with Introduction of Simultaneous, Comprehensive Interventions.

BACKGROUND: Surgical quality improvement collaboratives (QICs) aim to improve patient outcomes through coaching, benchmarked data reporting, and other activities. Although other regional QICs have formed organically over time, it is unknown whether a comprehensive quality improvement program implemented simultaneously across hospitals at the formation of a QIC would improve patient outcomes. STUDY DESIGN: Patients undergoing surgery at 48 hospitals in the Illinois Surgical Quality Improvement Collaborative (ISQIC) were included. Risk-adjusted rates of postoperative morbidity and mortality were compared from baseline to year 3. Difference-in-differences analyses compared ISQIC hospitals with hospitals in the NSQIP Participant Use File (PUF), which served as a control. RESULTS: There were 180,582 patients who underwent surgery at ISQIC-participating hospitals. Inpatient procedures comprised 100,219 (55.5%) cases. By year 3, risk-adjusted rates of death or serious morbidity decreased in both ISQIC (relative reduction 25.0%, p < 0.001) and PUF hospitals (7.8%, p < 0.001). Adjusted difference-in-differences analysis revealed that ISQIC participation was associated with a significantly greater reduction in death or serious morbidity (odds ratio 0.94, 95% CI 0.90 to 0.99, p = 0.01) compared with PUF hospitals. Relative reductions in risk-adjusted rates of other outcomes were also seen in both ISQIC and PUF hospitals (morbidity 22.4% vs 6.4%; venous thromboembolism 20.0% vs 5.0%; superficial surgical site infection 27.3% vs 7.7%, all p < 0.05), although these difference-in-differences did not reach statistical significance. CONCLUSIONS: Although complication rates decreased at both ISQIC and PUF hospitals, participation in ISQIC was associated with a significantly greater improvement in death or serious morbidity. These results underscore the potential of QICs to improve patient outcomes.

Defining obstacles to emergency transfer of trauma patients: An evaluation of retriage processes from nontrauma and lower-level Illinois trauma centers.

BACKGROUND: Retriage is the emergency transfer of severely injured patients from nontrauma and lower-level trauma centers to higher-level trauma centers. We identified the barriers to retriage at sending centers in a single health system. METHODS: We conducted a failure modes effects and criticality analysis at 4 nontrauma centers and 5 lower-level trauma centers in a single health system. Clinicians from each center described the steps in the trauma assessment and retriage process to create a process map. We used standardized scoring to characterize each failure based on frequency, impact on retriage, and prevention safeguards. We ranked each failure using the scores to calculate a risk priority number. RESULTS: We identified 26 steps and 93 failures. The highest-risk failure was refusal by higher-level trauma centers (receiving hospitals) to accept a patient. The most critical failures in the retriage process based on total risk, frequency, and safeguard scores were (1) refusal from a receiving higher-level trauma center to accept a patient (risk priority number = 191), (2) delay in a sending center's consultant examination of a patient in the emergency department (risk priority number = 177), and (3) delay in receiving hospital's consultant calling back (risk priority number = 177). CONCLUSION: We identified (1) addressing obstacles to determining clinical indications for retriage and (2) identifying receiving level I trauma centers who would accept the patient as opportunities to increase timely retriage. Establishing clear clinical indications for retriage that sending and receiving hospitals agree on represents an opportunity for intervention that could improve the retriage of injured patients.

Association between Patient and Hospital Characteristics and Adherence to a Surgical Site Infection Reduction Bundle in a Statewide Surgical Quality Improvement Collaborative.

BACKGROUND: Adherence to bundled interventions can reduce surgical site infection (SSI) rates; however, predictors of successful implementation are poorly characterized. We studied the association of patient and hospital characteristics with adherence to a colorectal SSI reduction bundle across a statewide surgical collaborative. STUDY DESIGN: A 16-component colorectal SSI reduction bundle was introduced in 2016 across a statewide quality improvement collaborative. Bundle adherence was measured for patients who underwent colorectal operations at participating institutions. Multivariable mixed-effects logistic regression models were constructed to estimate associations of patient and hospital factors with bundle adherence and quantify sources of variation. RESULTS: Among 2,403 patients at 35 hospitals, a median of 11 of 16 (68.8%, interquartile range 8 to 13) bundle elements were completed. The likelihood of completing 11 or more elements was increased for obese patients (56.8% vs 51.5%, odds ratio [OR] 1.39, 95% CI 1.05 to 1.86, p = 0.022) but reduced for underweight patients (31.0% vs 51.5%, OR 0.51, 95% CI 0.26 to 1.00, p = 0.048) compared with patients with a normal BMI. Lower adherence was noted for patients treated at safety net hospitals (n = 9 hospitals, 24.4% vs 54.4%, OR 0.08, 95% CI 0.01 to 0.44, p = 0.004). The largest proportion of adherence variation was attributable to hospital factors for six bundle elements, surgeon factors for no elements, and patient factors for nine elements. CONCLUSION: Adherence to an SSI reduction bundle is associated with patient BMI and hospital safety net status. Quality improvement groups should consider institutional traits for optimal implementation of SSI bundles. Safety net hospitals may require additional focus to overcome unique implementation barriers.

The Unfulfilled Need for Technical Skill Assessments Among Academic Cardiothoracic Surgeons.

Technical skill is a proven predictor of surgical outcomes, yet no platform exists for continual technical skill development following training. We aim to characterize the perceived need for feedback on technical skill among practicing thoracic surgeons. Under the Thoracic Education Cooperative Group, a panel of cardiothoracic surgeons and trainees developed and distributed an online survey for cardiothoracic surgery faculty in the Thoracic Surgery Directors Association database. The survey solicited demographics, perceived need for constructive feedback, barriers to sharing critiques, and preferences of desired peer reviewers. One hundred forty surgeons responded to our survey (response rate: 19.6% [140/713]). Most respondents had practiced for greater than 15 years (49.3%, 69/140). About 76.4% (107/140) of responders agreed or strongly agreed receiving feedback on their technical skills would help them improve, and 71.5% (100/140) desired individualized skills feedback. While 61.4% (86/140) of surgeons received meaningful technical skill feedback as attending surgeons, this was infrequent, with 63.3% (88/139) last receiving feedback over 12 months prior. Commonly cited barriers to sharing feedback included lack of common practice, time constraints, and hierarchical barriers. About 66.2% (92/139) of participants would spend at least 10 minutes providing peer feedback to receive feedback on their own skills, while 45.3% (63/139) would spend greater than 20 minutes. Attending thoracic surgeons identify an unmet desire for ongoing, constructive feedback on their technical skills following training. Surgeons feel critique fosters improvement and would devote significant time to engaging in peer feedback. A platform for exchange of technical skill feedback is warranted.

A National Mixed-Methods Evaluation of Preparedness for General Surgery Residency and the Association With Resident Burnout.

Importance: Differences in medical school experiences may affect how prepared residents feel themselves to be as they enter general surgery residency and may contribute to resident burnout. Objectives: To assess preparedness for surgical residency, to identify factors associated with preparedness, to examine the association between preparedness and burnout, and to explore resident and faculty perspectives on resident preparedness. Design, Setting, and Participants: This cross-sectional study used convergent mixed-methods analysis of data from a survey of US general surgery residents delivered at the time of the 2017 American Board of Surgery In-Training Examination (January 26 to 31, 2017) in conjunction with qualitative interviews of residents and program directors conducted as part of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial. A total of 262 Accreditation Council for Graduate Medical Education-approved US general surgery residency programs participated. Survey data were collected from 3693 postgraduate year (PGY) 1 and PGY2 surgical residents (response rate, 99%) and 98 interviews were conducted with residents and faculty from September 1 to December 15, 2018. Data were analyzed from June 1, 2017, to February 15, 2018. Main Outcomes and Measures: Hierarchical regression models were developed to examine factors associated with preparedness and to assess the association between preparedness and resident burnout. Qualitative interviews were conducted to identify themes associated with preparation for residency. Results: Of the 3693 PGY1 and PGY2 residents who participated (2258 male [61.1%]), 1775 (48.1%) reported feeling unprepared for residency. Approximately half of surgery residents took overnight call infrequently (≤2 per month) during their core medical student clerkship (1904 [51.6%]) or their subinternship (1600 [43.3%]); 524 (14.2%) took no call during their core clerkship. In multivariable analysis, residents were more likely to report feeling unprepared for residency if they were female (odds ratio [OR], 1.34; 95% CI, 1.15-1.57) or did not take call as a medical student (OR for 0 vs >4 calls, 2.72; 95% CI, 2.10-3.52). Residents who did not complete a subinternship were less likely to report feeling prepared for residency (OR, 0.68; 95% CI, 0.48-0.96). Feeling adequately prepared for residency was associated with a nearly 2-fold lower risk of experiencing burnout symptoms (OR, 0.57; 95% CI, 0.48-0.68). In interviews, the dominant themes associated with preparedness included the following: (1) various regulations limit the medical school experience, (2) overnight call facilitates preparation and selection of a specialty compatible with their preferences, and (3) adequate perceptions of residency improve expectations, resulting in improved preparedness, lower burnout rates, and lower risk of attrition. Conclusions and Relevance: In this cross-sectional study, the perception of feeling unprepared was associated with inadequate exposure to resident responsibilities while in medical school. These findings suggest that effective preparation of medical students for residency may result in lower rates of subsequent burnout.

Association Between Implementing Comprehensive Learning Collaborative Strategies in a Statewide Collaborative and Changes in Hospital Safety Culture.

Importance: Hospital safety culture remains a critical consideration when seeking to reduce medical errors and improve quality of care. Little is known regarding whether participation in a comprehensive, multicomponent, statewide quality collaborative is associated with changes in hospital safety culture. Objective: To examine whether implementation of a comprehensive, multicomponent, statewide surgical quality improvement collaborative is associated with changes in hospital safety culture. Design, Setting, and Participants: In this survey study, the Safety Attitudes Questionnaire, a 56-item validated survey covering 6 culture domains (teamwork, safety, operating room safety, working conditions, perceptions of management, and employee engagement), was administered to a random sample of physicians, nurses, operating room staff, administrators, and leaders across Illinois hospitals to assess hospital safety culture prior to launching a new statewide quality collaborative in 2015 and then again in 2017. The final analysis included 1024 respondents from 36 diverse hospitals, including major academic, community, and rural centers, enrolled in ISQIC (Illinois Surgical Quality Improvement Collaborative). Exposures: Participation in a comprehensive, multicomponent statewide surgical quality improvement collaborative. Key components included enrollment in a common standardized data registry, formal quality and process improvement training, participation in collaborative-wide quality improvement projects, funding support for local projects, and guidance provided by surgeon mentors and process improvement coaches. Main Outcomes and Measures: Perception of hospital safety culture. Results: The overall survey response rate was 43.0% (580 of 1350 surveys) in 2015 and 39.0% (444 of 1138 surveys) in 2017 from 36 hospitals. Improvement occurred in all the overall domains, with significant improvement in teamwork climate (change, 3.9%; P = .03) and safety climate (change, 3.2%; P = .02). The largest improvements occurred in individual measures within domains, including physician-nurse collaboration (change, 7.2%; P = .004), reporting of concerns (change, 4.7%; P = .009), and reduction in communication breakdowns (change, 8.4%; P = .005). Hospitals with the lowest baseline safety culture experienced the largest improvements following collaborative implementation (change range, 11.1%-14.9% per domain; P < .05 for all). Although several hospitals experienced improvement in safety culture in 1 domain, most hospitals experienced improvement across several domains. Conclusions and Relevance: This survey study found that hospital enrollment in a statewide quality improvement collaborative was associated with overall improvement in safety culture after implementing multiple learning collaborative strategies. Hospitals with the poorest baseline culture reported the greatest improvement following implementation of the collaborative.

Leveraging a Comprehensive Program to Implement a Colorectal Surgical Site Infection Reduction Bundle in a Statewide Quality Improvement Collaborative.

OBJECTIVES: Our objective was to examine the implementation and associated clinical outcomes of a comprehensive surgical site infection (SSI) reduction bundle in a large statewide surgical quality improvement collaborative leveraging a multifaceted implementation strategy. SUMMARY BACKGROUND DATA: Bundled perioperative interventions reduce colorectal SSI rates when enacted at individual hospitals, but the ability to implement comprehensive SSI bundles and to examine the resultant clinical effectiveness within a larger, diverse population of hospitals is unknown. METHODS: A multifaceted SSI reduction bundle was developed and implemented in a large statewide surgical quality improvement collaborative through a novel implementation program consisting of guided implementation, data feedback, mentorship, process improvement training/coaching, and targeted-implementation toolkits. Bundle adherence and ACS NSQIP outcomes were examined preimplementation versus postimplementation. RESULTS: Among 32 hospitals, there was a 2.5-fold relative increase in the proportion of patients completing at least 75% of bundle elements (preimplementation = 19.5% vs. postimplementation = 49.8%, P = 0.001). Largest adherence gains were seen in wound closure re-gowning/re-gloving (24.0% vs. 62.0%, P < 0.001), use of clean closing instruments (32.1% vs. 66.2%, P = 0.003), and preoperative chlorhexidine bathing (46.1% vs. 77.6%, P < 0.001). Multivariable analyses showed a trend toward lower risk of superficial incisional SSI in the postimplementation period compared to baseline (OR 0.70, 95% CI 0.49-10.2, P = 0.06). As the adherence in the number of bundle elements increased, there was a significant decrease in superficial SSI rates (lowest adherence quintile, 4.6% vs. highest, 1.5%, P < 0.001). CONCLUSIONS: A comprehensive multifaceted SSI reduction bundle can be successfully implemented throughout a large quality improvement learning collaborative when coordinated quality improvement activities are leveraged, resulting in a 30% decline in SSI rates. Lower superficial SSI rates are associated with the number of adherent bundle elements a patient receives, rendering considerable benefits to institutions capable of implementing more components of the bundle.

Gender Differences in Utilization of Duty-hour Regulations, Aspects of Burnout, and Psychological Well-being Among General Surgery Residents in the United States.

OBJECTIVE: The aim of the study was to (1) assess differences in how male and female general surgery residents utilize duty-hour regulations and experience aspects of burnout and psychological well-being, and (2) to explore reasons why these differing experiences exist. BACKGROUND: There may be differences in how women and men enter, experience, and leave residency programs. METHODS: A total of 7395 residents completed a survey (response rate = 99%). Logistic regression models were developed to examine the association between gender and resident outcomes. Semistructured interviews were conducted with 42 faculty and 56 residents. Transcripts were analyzed thematically using a constant comparative approach. RESULTS: Female residents reported more frequently staying in the hospital >28 hours or working >80 hours in a week (≥3 times in a month, P < 0.001) and more frequently feeling fatigued and burned out from their work (P < 0.001), but less frequently "treating patients as impersonal objects" or "not caring what happens" to them (P < 0.001). Women reported more often having experienced many aspects of poor psychological well-being such as feeling unhappy and depressed or thinking of themselves as worthless (P < 0.01). In adjusted analyses, associations remained significant. Themes identified in the qualitative analysis as possible contributory factors to gender differences include a lack of female mentorship/leadership, dual-role responsibilities, gender blindness, and differing pressures and approaches to patient care. CONCLUSIONS: Female residents report working more, experiencing certain aspects of burnout more frequently, and having poorer psychological well-being. Qualitative themes provide insights into possible cultural and programmatic shifts to address the concerns for female residents.

Use and Underlying Reasons for Duty Hour Flexibility in the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial.

BACKGROUND: The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial randomly assigned surgical residency programs to either standard duty hour policies or flexible policies that eliminated caps on shift lengths and time off between shifts. Our objectives were to assess adherence to duty hour requirements in the Standard Policy arm and examine how often and why duty hour flexibility was used in the Flexible Policy arm. STUDY DESIGN: A total of 3,795 residents in the FIRST trial completed a survey in January 2016 (response rate >95%) that asked how often and why they exceeded current standard duty hour limits in both study arms. RESULTS: Flexible Policy interns worked more than 16 hours continuously at least once in a month more frequently than Standard Policy residents (86% vs 37.8%). Flexible Policy residents worked more than 28 hours once in a month more frequently than Standard Policy residents (PGY1: 64% vs 2.9%; PGY2 to 3: 62.4% vs 41.9%; PGY4 to 5: 52.2% vs 36.6%), but this occurred most frequently only 1 to 2 times per month. Although residents reported working more than 80 hours in a week 3 or more times in the most recent month more frequently under Flexible Policy vs Standard Policy (19.9% vs 16.2%), the difference was driven by interns (30.9% vs 19.6%), and there were no significant differences in exceeding 80 hours among PGY2 to 5 residents. The most common reasons reported for extending duty hours were facilitating care transitions (76.6%), stabilizing critically ill patients (70.7%), performing routine responsibilities (67.9%), and operating on patients known to the trainee (62.0%). CONCLUSIONS: There were differences in duty hours worked by residents in the Flexible vs Standard Policy arms of the FIRST trial, but it appeared that residents generally used the flexibility for patient care and educational opportunities selectively.

Exploring Qualitative Perspectives on Surgical Resident Training, Well-Being, and Patient Care.

BACKGROUND: The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial found no difference in patient outcomes or resident well-being between more restrictive and flexible duty hour policies. Qualitative methods are appropriate for better understanding the experience and perceptions of those affected by duty hour regulations. We conducted a pilot qualitative study on how resident duty hour regulations are perceived by general surgery program directors, surgical residents, and attending surgeons who participated in the FIRST Trial. STUDY DESIGN: Semi-structured qualitative interviews were pilot tested with program directors, residents, and attendings to examine initial perceptions of the standard and flexible policies implemented during the trial. The transcribed interviews were analyzed thematically using a constant comparative approach and grouped first by study arm and then by level (patient, surgeon, program, and national). RESULTS: More restrictive duty hours were perceived as creating a tension between resident personal and professional well-being. Standard Policy resulted in more transitions, which was perceived as creating vulnerable gaps in patient care. Standard Policy restrictions were seen as particularly challenging for interns and often led to inadequate preparation for promotion and encouraged a shift mentality. CONCLUSIONS: In our pilot study, interviewees valued the flexibility afforded in the Flexible Policy arm, as it allowed them to maximize patient safety and educational attainment. Additional qualitative research will expand on program director, resident, and attending perceptions of resident duty hours as well as perceptions of patient safety. Qualitative methods can contribute to the national debate on resident duty hours.

Program Director Perceptions of Surgical Resident Training and Patient Care under Flexible Duty Hour Requirements.

BACKGROUND: The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial was a national, cluster-randomized, pragmatic, noninferiority trial of 117 general surgery programs, comparing standard ACGME resident duty hour requirements ("Standard Policy") to flexible, less-restrictive policies ("Flexible Policy"). Participating program directors (PDs) were surveyed to assess their perceptions of patient care, resident education, and resident well-being during the study period. STUDY DESIGN: A survey was sent to all PDs of the general surgery residency programs participating in the FIRST trial (N = 117 [100% response rate]) in June and July 2015. The survey compared PDs' perceptions of the duty hour requirements in their arm of the FIRST trial during the study period from July 1, 2014 to June 30, 2015. RESULTS: One hundred percent of PDs in the Flexible Policy arm indicated that residents used their additional flexibility in duty hours to complete operations they started or to stabilize a critically ill patient. Compared with the Standard Policy arm, PDs in the Flexible Policy arm perceived a more positive effect of duty hours on the safety of patient care (68.9% vs 0%; p < 0.001), continuity of care (98.3% vs 0%; p < 0.001), and resident ability to attend educational activities (74.1% vs 3.4%; p < 0.001). Most PDs in both arms reported that safety of patient care (71.8%), continuity of care (94.0%), quality of resident education (83.8%), and resident well-being (55.6%) would be improved with a hypothetical permanent adoption of more flexible duty hours. CONCLUSIONS: Program directors involved in the FIRST trial perceived improvements in patient safety, continuity of care, and multiple aspects of resident education and well-being with flexible duty hours.

National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training.

BACKGROUND: Concerns persist regarding the effect of current surgical resident duty-hour policies on patient outcomes, resident education, and resident well-being. METHODS: We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving 117 general surgery residency programs in the United States (2014-2015 academic year). Programs were randomly assigned to current Accreditation Council for Graduate Medical Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies that waived rules on maximum shift lengths and time off between shifts (flexible-policy group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their well-being, education, and patient care. RESULTS: In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies were not associated with an increased rate of death or serious complications (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P=0.92; unadjusted odds ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P=0.44; noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. Among 4330 residents, those in programs assigned to flexible policies did not report significantly greater dissatisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P=0.86) or well-being (14.9% and 12.0%, respectively; P=0.10). Residents under flexible policies were less likely than those under standard policies to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education but were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety. Residents in the flexible-policy group were less likely than those in the standard-policy group to report leaving during an operation (7.0% vs. 13.2%, P<0.001) or handing off active patient issues (32.0% vs. 46.3%, P<0.001). CONCLUSIONS: As compared with standard duty-hour policies, flexible, less-restrictive duty-hour policies for surgical residents were associated with noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality. (FIRST ClinicalTrials.gov number, NCT02050789.).

Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies.

IMPORTANCE: Debate continues regarding whether to further restrict resident duty hour policies, but little high-level evidence is available to guide policy changes. OBJECTIVE: To inform decision making regarding duty hour policies, the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial is being conducted to evaluate whether changing resident duty hour policies to permit greater flexibility in work hours affects patient postoperative outcomes, resident education, and resident well-being. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic noninferiority cluster-randomized trial of general surgery residency programs with 2 study arms. Participating in the study are Accreditation Council for Graduate Medical Education (ACGME)-approved US general surgery residency programs (n = 118), their affiliated hospitals (n = 154), surgical residents and program directors, and general surgery patients from July 1, 2014, to June 30, 2015, with additional patient safety outcomes collected through June 30, 2016. The data collection platform for patient outcomes is the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), thus only hospitals participating in the ACS NSQIP were included. INTERVENTIONS: In the usual care arm, programs adhered to current ACGME resident duty hour standards. In the intervention arm, programs were allowed to deviate from current standards regarding maximum shift lengths and minimum time off between shifts through an ACGME waiver. MAIN OUTCOMES AND MEASURES: Death or serious morbidity within 30 days of surgery measured through ACS NSQIP, as well as resident satisfaction and well-being measured through a survey delivered at the time of the 2015 American Board of Surgery in Training Examination (ABSITE). RESULTS: A total of 118 general surgery residency programs and 154 hospitals were enrolled in the FIRST Trial and randomized. Fifty-nine programs (73 hospitals) were randomized to the usual care arm and 59 programs (81 hospitals) were randomized to the intervention arm. Intent-to-treat analysis will be used to estimate the effectiveness of assignment to the intervention arm on patient outcomes, resident education, and resident well-being compared with the usual care arm. Several sensitivity analyses will be performed to determine whether there were differential effects when examining only inpatients, high-risk patients, and emergent/urgent cases. CONCLUSIONS AND RELEVANCE: To our knowledge, the FIRST Trial is the first national randomized clinical trial of duty hour policies. Results of this study may be informative to policymakers and other stakeholders engaged in restructuring graduate medical training to enhance the quality of patient care and resident education. TRIAL REGISTRATION: clinicaltrials.org Identifier: NCT02050789.