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Moving from FIRST to SECOND: Moving from FIRST to SECOND:

Moving from FIRST to SECOND: - PowerPoint Presentation

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Moving from FIRST to SECOND: - PPT Presentation

Moving from FIRST to SECOND A Proposal for Another National Trial to Improve the Surgical Learning Environment Karl Bilimoria MD MS John B Murphy Professor of Surgery Vice President Quality Northwestern Medicine ID: 774264

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Moving from FIRST to SECOND: A Proposal for Another National Trial to Improve the Surgical Learning Environment Karl Bilimoria MD MS John B. Murphy Professor of Surgery Vice President – Quality, Northwestern Medicine Director, Surgical Outcomes and Quality Improvement Center Associate Program DirectorFeinberg School of Medicine, Northwestern UniversityYue-Yung Hu MD MPHAssistant Professor of SurgeryAssociate Program Director for WellnessLurie Children’s HospitalDavid Hoyt, MDExecutive DirectorAmerican College of Surgeons

Surgical Community Came Together for FIRST Trial and Changed National Policy

FIRST Trial Examined Resident Well-Being Flexible Policy Standard Policy Randomize General Surgery Programs Data Collection : July 1, 2014 to June 30, 2015 PATIENT OUTCOMES Primary Outcome : Death or Serious Morbidity Composite Secondary Outcomes : Death, Serious Morbidity, Any Morbidity, Failure to Rescue, Reoperation, Complications vs. RESIDENT OUTCOMES Primary Outcomes : Overall Wellbeing and Education Secondary Outcomes : Resident perceptions of care, continuity, education, wellbeing, personal safety; Test performance

Prevalence of Burnout Symptoms among General Surgery Residents in the U.S. At least weekly symptoms Emotional exhaustion 53.2%Depersonalization 25.6%Psychiatric wellbeing Median 3 (IQR 1-5)43% met criteria for poor psychiatric wellbeing 39% From national post-ABSITE survey with 99% response rate

In Examining the Long-term FIRST Trial Results, Resident Well-being Worsened Over Time in Both Arms 2015 2016 2017 2018 Satisfaction with: program's duty hour regulations 91.9% 92.5% 93.0% 94.3% p=0.03 work hours and scheduling 87.9% 87.4% 86.3% 89.4% p=0.03 continuity of care 95.3% 96.2% 96.7% 97.0% p<0.05 patient safety 96.5% 96.8% 96.7% 97.3% p=0.60 handoffs/transitions 93.0% 93.0% 92.9% 93.4% p=0.95 overall resident education 89.0% 89.2% 89.3% 89.4% p=0.99 time for rest81.4%79.5%78.1%78.4%p=0.07overall wellbeing85.1%83.0%81.8%81.5%p=0.02During most recent month did you:miss conference13.3%15.5%13.4%15.4%p=0.08hand off active patient care32.0%32.4%26.4%28.5%p<0.001hand off critically ill patient.24.6%19.5%21.7%p<0.001leave operation7.0%6.4%5.6%6.4%p=0.37miss operation29.9%29.0%21.7%23.6%p<0.001return to hospital to operate45.5%44.0%37.2%29.5%p<0.001return to hospital to care for pt50.4%48.2%41.9%33.4%p<0.001

Focus Groups and Interviews with PDs “Always hearing about resident burnout and wellness problems”Hard to quantifyPrograms have no way to measure or benchmark Hard to solveNot sure what to implement or even what the options areInterventions are only available by word-of-mouth; no catalog Interventions are context-specific and rarely surgical – not easy to exportNo robust data on whether existing interventions work

FIRST Trial Participants Poised to Become an Innovative Surgical Education Trials Group Abington Memorial Hospital Alegent Creighton Health, Creighton University Medical Center Baptist Memorial Hospital Memphis Barnes-Jewish Hospital at Washington University Medical Center Barnes-Jewish West County Hospital Baylor University Medical CenterBaystate Medical Center Beaumont Hospital Grosse Pointe Beth Israel Deaconess Medical Center Brigham & Women's Hospital Brigham and Women's Faulkner Hospital Bronson Methodist Hospital Carilion Clinic/ Carilion Medical Center Carle Foundation Hospital Carolinas Medical Center Christiana Care Health System Cleveland Clinic Foundation Cooper University Hospital Dallas County Hospital District d/b/a Parkland Health & Hospital System Danbury Hospital Dartmouth-Hitchcock Medical Center Duke University Hospital Eisenhower Army Medical Center Emory University Hospital Erlanger Health System at Chattanooga Exempla Saint Joseph Hospital Fletcher Allen Health Care - Hospital George Washington University Hospital Good Samaritan Hospital ( TriHealth ) Gundersen Lutheran Medical Center Hackensack University Medical Center Hahnemann University Hospital Hartford Hospital Hennepin County Medical Center Henry Ford Hospital Hospital of the University of Pennsylvania Houston Methodist HospitalIndiana University Health - Methodist HospitalIndiana University Hospital, IU HealthInova Fairfax HospitalIntermountain Medical CenterIowa Methodist Medical CenterJohns Hopkins HospitalKaiser Foundation Hospital OaklandKaiser Foundation Hospital SacramentoKaiser Permanente San Francisco Medical CenterKaiser Permanente Santa Clara Medical CenterKaiser Sunnyside Medical CenterKapiolani Medical Center for Women & ChildrenLahey ClinicLegacy Emanuel Hospital & Health CenterLegacy Good Samaritan Medical CenterMaine Medical CenterMassachusetts General HospitalMayo Clinic Arizona d/b/a Mayo Clinic HospitalMayo Clinic Hospital Rochester - Methodist CampusMayo Clinic Rochester – Saint Marys CampusMedical Center of Central GeorgiaMedical University Hospital AuthorityMemorial Health University Medical CenterMemorial Hermann Hospital - TMCMemorial Hermann SouthwestMemorial Medical CenterMercy Medical Center (Des Moines, IA)Meriter HospitalMethodist University HospitalMetroHealth Medical CenterMorristown Medical CenterMountain States Health Alliance d/b/a Johnson City Medical CenterNaval Medical Center Portsmouth, VirginiaNew Hanover Regional Medical CenterNewark Beth Israel Medical CenterNewton-Wellesley HospitalNorthwestern Memorial HospitalOchsner Clinic FoundationOregon Health & Science UniversityOrlando Regional Medical Center (FSCI)OSF Saint Francis Medical CenterPenn State Milton S. Hershey Medical CenterPennsylvania Hospital, UPHSProvidence Portland Medical CenterProvidence St. Vincent Medical CenterRhode Island HospitalRiverside County Regional Medical CenterRobert Packer HospitalRonald Reagan UCLA Medical CenterRush University Medical CenterSaint Francis Hospital - Memphis, TNSaint Francis Hospital & Medical CenterSaint Joseph Mercy HospitalSaint Louis University HospitalSaint Mary's Hospital (CT)Saint Thomas West HospitalSaint Vincent Hospital - IndianapolisSanta Barbara Cottage HospitalScott & White HospitalSinai Hospital of BaltimoreSparrow HospitalSpectrum Health HospitalsStamford HospitalStanford Hospital and ClinicsStraub Clinic and HospitalSutter West Bay Hospitals d/b/a California Pacific Medical CenterTampa General Hospital (FSCI)Tarrant County Hosp District / JPS Health NetworkTemple University HospitalThe Christ HospitalThe Hospital of Central ConnecticutThe Jewish HospitalThe Miriam HospitalThe Nebraska Medical CenterThe Ohio State University Wexner Medical CenterThe Queen's Medical CenterThe Regional Medical Center at MemphisThomas Jefferson University HospitalTruman Medical CenterTufts Medical CenterUF Health Jacksonville (FSCI)UMass Memorial Medical CenterUNC HospitalsUniversity Hospital (Newark, NJ)University Hospital (San Antonio, TX) University of Alabama at Birmingham Hospital University of California Davis Medical Center University of California Irvine Medical Center University of California San Francisco Medical Center University of Colorado Hospital University of Connecticut Health Center Finance Corp On behalf of University of Iowa Hospitals and Clinics University of Kansas Hospital - Kansas City, KS University of Kentucky Hospital University of Maryland Medical Center University of Minnesota Medical Center, Fairview University of Missouri Hospital University of Tennessee Medical Center-Knoxville University of Texas M.D. Anderson Cancer Center University of Texas Medical Branch University of Utah Hospitals and Clinics University of Virginia Health System at Charlottesville University of Washington Medical Center University of Wisconsin Hospital & Clinics UPMC Presbyterian UT Southwestern University Hospital Vanderbilt University Hospital Vidant Medical Center Wake Forest Baptist Health Wellmont Bristol Regional Medical Center West Virginia University Hospitals William Beaumont Hospital (Royal Oak) Winchester Medical Center Womack Army Medical Center York Hospital Beaumont Hospital Grosse Pointe Detroit Receiving Hospital Harper University Hospital Henry Ford Hospital Huron Valley Hospital Sparrow Hospital Spectrum Health Butterworth St. John Hospital and Medical Center St. Joseph Mercy Hospital University of Michigan Health System

The SECOND Trial is a Partnership

The SECOND Trial: A National Pragmatic, Cluster-Randomized Trial Intervention Control 320 Eligible Surgical Residency Programs Timeframe : 9/1/2019 to 6/30/2022 Resident Wellbeing : Burnout*, job satisfaction, attrition, suicidal thoughts Educational Outcomes : Exam performance, CaseLog , Operative Performance Patient Outcomes : ACS NSQIP and Medicare vs. ~7/1/2022: All Get Intervention

All Programs Receive Wellness Report & Suicidality InterventionsAll programs get interventions to address suicidal thoughts Recipients:PDChair DIO Each program receives a nationally benchmarked report of their residents’ well-being based on de-identified responses from ABSITE survey

Intervention Programs Receive Additional Information, Access to Wellness Toolkit, & Implementation Support Targeted Reports Targeted Improvements Toolkit Toolkit Wellness Toolkit Emotional ExhaustionSMARTR trainingPeer support trainingDifficult caseconferencesProtected half-days Scheduled groupcounseling Implementation Support Process improvement coaching Collaboration networking Topical expertise

Additional Themes about the Learning Environment Are Under DevelopmentService vs Education Balance AutonomyCamaraderieFaculty EngagementDealing with Adverse Events BullyingHarassmentDiscriminationDuty Hours ViolationsResidents Preparedness to Respond ABSITE resident survey PD survey ACGME resident survey ACGME faculty survey Interviews/focus groups

Wellness Toolkit is Currently Being Developed Program Director Survey (Wellness Inventory)Phone calls with program directors & coordinators to clarify/gather additional detail Literature review & guidelinesProgram Tours (20-30)Identify by Data PD surveySnowball samplingObservationsInterviews/focus groups Policy/procedure review ResidentsAttendings NursesChair and PDGMEC / DIO

Sample Wellness Toolkit Interventions Chair: John Sweeney, MD PD: Keith Delman , MD (kdelman@emory.edu) Half-Weekday Off per MonthHow we did it Arranging coverageMitigating safety issuesKeys to success Chair: Mary Hawn, MDPD: David Spain, MD (dspain@stanford.edu) High Performance Team TrainingHow we did itIdentifying a psychologist who understands surgical trainingConvincing surgeons to goArranging coverageWhat did it cost? Keys to success Chair: Rebecca Minter, MD PD: Jacob Greenberg, MD (jgreenberg@uw.edu) Lactation Policy How we did it Finding appropriate space at each clinical site Training faculty/residents Keys to success

Potential Ways to Ensure Education and Patient Care Are Unaffected by Well-Being For resident educationABSITE (scores)ABS QE & CE (pass rates)ACGME CaseLog (procedural volumes)ABSITE surveys (perception)SIMPL/ ZwischMe (operative autonomy)*For patient careACS NSQIP (death, morbidity)* Medicare (death, morbidity, cost) Intervention vs. ControlIntention to treatAs treated *subset of programs

Frequently Asked Questions How do you protect confidentiality?For residentsABSITE survey data de-identified Program-specific reporting in quartiles (not number or % of residents) Suppress items with low denominators (e.g., gender, minority) Program Tour interviews confidential; no feedback to leadership

Frequently Asked Questions How do you protect confidentiality?For residentsFor programs ACGME has no access to data (contractual)Programs are not allowed to advertise their own data (contractual)Individual program chairs/PDs decide whether to release their own data to their own residents/faculty/administration

Frequently Asked Questions How do you protect confidentiality?Does being in the control arm mean I can’t work to improve my residents’ wellness? Does being in the intervention arm mean I have to do everything in the Wellness Toolkit? Pragmatic Trial: no mandates or prohibitions, all programs get to pick entirely what they work on and implementControl Arm: Review data; Intervene on their own (without Wellness Toolkit access) and/or do nothingIntervention Arm: Review data; Select interventions from Toolkit and/or elsewhere and/or do nothing All report what they worked on in annual Program Director SurveyWe want it to be easy for programs to participate

Program Tours 1 st Report Toolkit Development Enrollment PD Survey Toolkit Dissemination Proposed Timeline Dissemination of Intervention to Control Arm Survey Survey Survey Survey Survey 2 nd Report 3 rd Report 4 th Report PD Survey PD Survey PD Survey Randomization

How Do We Sign Up? Complete Program Director Survey (personalized link was emailed to you) SECOND Trial enrollment formSignatories: PD, Chair, DIOIRB process similar to FIRST Trial Northwestern IRB: non-human subjects research Up to each program whether they submit to their IRB and howWe can provide documentation if you choose to submit We may call you after enrollment to clarify your Program Director Survey results

Moving from FIRST to SECOND: A Proposal for Another National Trial to Improve the Surgical Learning Environment SECOND@northwestern.edu Karl Bilimoria MD MSYue-Yung Hu MD MPH