Presentation on theme: "Changes in Duty Hour Requirements"— Presentation transcript:
1 Flexibility In duty hour Requirements for Surgical Training Trial “The FIRST Trial”
2 Changes in Duty Hour Requirements 2003:80 hours1 in 7 days off1 in 3 call8-10 hours off between shifts2011 Changes16 hours for internsIntern supervision14 hours off after 24h call: IOM report and public pressure
3 Evidence in Surgery Unclear Patient outcomes: trend to worse Resident wellbeing: inconsistentCertification exams: trend to worse
4 Widespread Concern New regulations may go too far Adverse consequences Continuity of carePatient ownershipShift work mentalityDecreasing certification exam scoresDecreased preparedness for fellowship/practiceNeed evidence to support changes
5 Opportunity Equipoise Discussions between ABS and ACGME Increasing flexibility in duty hour regulationsBetter outcomes: ↑↑continuity of careWorse outcomes: tired residents make mistakesDiscussions between ABS and ACGMEWillingness to eliminate some duty hour requirements if evidence based
8 Pragmatic Cluster Randomized Trial Surgical Residency Programs/HospitalsRandomize Hospitals/ProgramsIntervention Arm(Flexible Duty Hour Requirements)vs.Usual Care Hospitals(Current Duty Hour Requirements)Data Collection: July 1, 2014 to June 30, 2015improved impressions regarding continuity of care, professionalism, professional integrity, patient ownership, and adequacy of training.Data Analysis: Comparison of OutcomesPrimary Outcome: Death or Serious Morbidity CompositeSecondary Outcomes: Death, Serious Morbidity, Any Morbidity, Individual Complications, Reoperations,Length of Stay, Readmission, Failure to RescueAssess Resident Perceptions of Duty Hour Regulationsthrough Survey Attached to January 2015 ABSITEAssess program case volumes, ABSITE scores, PD survey
9 Current Resident Duty Hours USUAL CARE/CONTROL ARM Flexible Resident Duty HoursINTERVENTION ARMDuty hours limited to 80 hours/week averaged over 4 weeksSameMinimum of one free day (no duty)/week averaged over 4 weeksMay not take in-house call more frequently than every 3rd night, averaged over 4 weeksPGY-1 resident duty periods must not exceed 16 hours EliminatedPGY-2 residents and above may work a maximum of 24 hours duty with an additional 4 hours for transitions in careResidents must have 14 hours off after 24 hours in-house duty and at least 8-10 hours off after a regular shiftEliminated *Chief Residents are to be given flexibility to manage their own hours without duty hour logs to maximize continuity of care for patients and to maximize this invaluable time for developing their decision making, technical skills, autonomy, dedication to patient care, and professionalism as they transition into independent practice.
10 ACGME Waiver Awaiting formal approval next week Waiver of common program requirements for 2 yearsApplies to all services and all residents on services overseen by General Surgery Residency ProgramRotators are includedAll hospitals included and can follow same rules
11 Intervention Arm: Recommend Changes Eliminated RuleRecommended ChangePGY-1 resident duty periods must not exceed 16 hoursPGY-1 residents should take call longer than 16 hours in a fashion similar to all other residents in the program.
12 Intervention Arm: Recommend Changes Eliminated RulesRecommended ChangeAll residents may work a maximum of 24 hours duty with an additional 4 hours for transitions in careResidents must have 14 hours off after 24 hours in-house duty and at least 8-10 hours off after a regular shiftFocus on maximizing continuity of patient care rather than simply exiting at the end of the shift. For example and not limited to:Unstable patients should be attended to by the admitting on-call resident until stabilizedPatients admitted by the on-call resident needing a surgery should be operated on by that resident.Residents that begin an operation should complete the procedure irrespective of whether their “shift” is over and any duty hour requirementsResidents should complete ongoing urgent patient evaluationsResidents should ensure proper handoffs and transitions in care
13 Analyses End points Subset Analyses Death or serious morbidity Other clinical outcomesResident perceptionsPD perceptionsSubset AnalysesCritically ill patientsInpatients only
14 IRB Approval Waiver obtained from Northwestern University IRB Intervention at hospital levelNo patient- or resident-identifiable data being collectedAnalysis of data already being collected for ACS NSQIP
15 Additional IRB Approvals Analyze the ACS NSQIP dataAnalyze the ABSITE survey dataAnalyze the ACGME caselog data
16 What Are You Agreeing To? Randomization to a study armAccess to duty logs, call schedules, and rotation schedulesAccess to de-identified ACGME Resident Caselog totals and ABSITE scoresAccess to de-identified hospital ACS NSQIP dataABSITE SurveyComplete data abstraction of all study period cases (general surgery CPTs only) by October 1, 2015 (allows 8 weeks beyond the 30 day postoperative period to close out the final cases of the study period).
17 Expected Results No difference in outcomes Return to more flexible resident duty hoursCulture change: Emphasize continuity of care, not clocking in/out
18 ACGME Waiver for Intervention Arm Hospitals TimelineACGME MeetingJuly 2014June 2015Oct2015Jan2016Jan 2014July 2016Data CollectionData AnalysisFeb2016Interim AnalysisABSITE SurveyACGME Waiver for Intervention Arm Hospitals
19 iCOMPARE Study Internal medicine study 60 programs Only addresses intern 16-hour ruleAllows interns to work 28 hours with 4 hour napUses Medicare data for outcome measurementFocus on sleep measurements/analysesExpected to run July 2015 to June 2017
20 FAQs Residency program with multiple hospitals If Residency Program approves, any hospital can enroll if in ACS NSQIPAll hospitals randomized to same study armWaiver applies to Residency Program so non-enrolled hospitals subject to same rulesRotators from other services and hospitalsSame rules apply
21 FAQs DIO approval needed Only ACS NSQIP VA and children’s hospitals excludedNew York eligibility?
23 Advisory Committee Karl Bilimoria MD MS (ACS, Northwestern) Frank Lewis, MD (American Board of Surgery)David Hoyt, MD (American College of Surgeons)Christine Kinnier, MD (MGH, resident)Clifford Ko, MD MS MSHS (American College of Surgeons, UCLA)David Mahvi, MD (American Board of Surgery, Northwestern)John Mellinger, MD (APDS, SIU)Ajit Sachdeva, MD (American College of Surgeons)Bill Scanlon (patient/public representative)John Tarpley, MD (APDS, Vanderbilt)
24 Why Should You Join? Minimal work for you Huge opportunity to influence resident duty hour requirementsNeed everyone to participate if we are to generate high-level, compelling evidence
25 Enroll ASAP!Enrollment forms sent to Chairs, PDs, and NSQIP Surgeon ChampionsRequest application by ingAdditional form will be sent in mid FebruaryDEADLINE: February 28, 2014Notification of study arm assignment by end of March
26 Questions Karl Bilimoria email@example.com Frank LewisAny of the other study team members
27 Flexibility In duty hour Requirements for Surgical Training Trial “The FIRST Trial”