The FIRST Resident Duty Hour Trial: Informing Policy with Evidence - PowerPoint PPT Presentation

The FIRST Resident Duty Hour Trial: Informing Policy with Evidence Karl Bilimoria MD MS John B. Murphy Professor of Surgery Vice President – Quality, Northwestern Medicine Director, Surgical Outcomes and Quality Improvement Center Vice Chair, Department of Surgery Feinberg School of Medicine, Northwestern University @kbilimoria

Major SOQIC Initiatives • P4P measure and program evaluations • Influencing policy • 55 Hospitals • Novel approaches to spur quality improvement • Platform for QI trials / improvement science • NMH quality initiatives • System Surgical Collaborative The FIRST Trial • 152 Hospitals Flexibility In duty hour • National trial of policy intervention Requirements for Surgical Trainees

Disclosures: FIRST Trial Funding

Public Pressure to Regulate Duty Hours • Resident union • Public interest groups • Patient and Physician Safety and Protection Act – 2001, 2003, 2005

Reforms of 2003 “… political backdrop in which groups pursued federal intervention to regulate resident hours… ” ACGME 2003 • 80 hours • 1 in 7 days off • 1 in 3 call • 24+4 hour limit • 8-10 hours off between shifts

Ann Rev Med, 2012

Philibert, Nasca, et al, Ann Rev Med, 2012

2008 IOM Report e

Reforms of 2011 • 16 hours for interns • 14 hours off after 24h call

2011 Duty Hour Changes 12 Death or Serious Morbidity 10 Risk-adjusted rate, % 8 OR (95% CI): 1.06 (0.94-1.20), P=0.35 6 4 2 0 July July 1 2 3 4 5 6 7 8 Time (in 6-month Intervals) 2013 2009 Rajaram/Bilimoria, JAMA Dec 2014

European Working Time Directive • 2009 • 48 hours per week • 13h per day • 20 min break q6h

No Large Randomized Trials

Flexibility In duty hour Requirements for Surgical Trainees Trial “The FIRST Trial” #FirstTrialSurgery

Pragmatic Cluster Randomized Trial Surgical Residency Programs/Hospitals Randomize Hospitals/Programs vs. Flexible Policy Standard Policy Data Collection : July 1, 2014 to June 30, 2015 PATIENT OUTCOMES RESIDENT OUTCOMES Primary Outcome : Death or Serious Primary Outcomes : Overall Wellbeing and Morbidity Composite Education Secondary Outcomes : Resident perceptions of Secondary Outcomes : Death, Serious care, continuity, education, wellbeing, Morbidity, Any Morbidity, Failure to personal safety; Test performance Rescue, Reoperation, Complications

Guiding Principles for Our Changes • Maximize continuity of care – Patient safety – Education • Provide residents flexibility to care for patients • Decrease regulatory/scheduling burden Bilimoria/Hoyt/Lewis, JAMA Surg 2015

Duty Hour Requirements - No Change STANDARD POLICY FLEXIBLE POLICY 80 hours per week NO CHANGE (averaged over 4 weeks) One day off per week NO CHANGE (averaged over 4 weeks) Call no more frequently than NO CHANGE every 3 rd night

Changes for Flexible Policy Arm YEAR STANDARD POLICY FLEXIBLE POLICY Maximum of 24 hours duty with 2003 an additional 4 hours for Eliminated transitions in care 2003 At least 8-10 hours off after a Eliminated regular shift 2011 PGY-1 resident duty periods must Eliminated not exceed 16 hours 2011 Residents must have 14 hours off Eliminated after 24 hours in-house duty

Study Arm Comparisons Standard Flexible TOTAL Policy Policy # of programs 117 59 58 # of hospitals 151 70 78 # of residents 4,330 2,220 2,110 # of patients 138,691 65,849 72,842

Patient Outcomes

Comparison of Patient Outcomes: Primary Outcome Favors FLEXIBLE Policy Favors STANDARD Policy Death/Serious Morbidity N=138,691 Unadjusted NONINFERIOR Adjusted Odds Ratio

Comparison of Patient Outcomes: Secondary Outcomes Favors FLEXIBLE Policy Favors STANDARD Policy Death UNADJUSTED Serious Morbidity ADJUSTED Any Morbidity Failure-to-Rescue Pneumonia Renal Failure Reoperation Sepsis SSI UTI Bilimoria, et al, NEJM 2016

Subgroup Analyses • Emergency surgery • High-risk patients No difference between study arms • Inpatients for any outcome • Resident involvement

Resident Outcomes

Resident-Reported Primary Outcomes 11% STANDARD Overall resident education quality N=3,642 1.08 (0.77-1.52); P=0.64 11% FLEXIBLE STANDARD 12% 1.31 (0.99-1.74); P=0.06 Overall wellbeing N=3,645 15% FLEXIBLE 0% 5% 10% 15% 20% 25% 30% 35% 40% Percent Dissatisfied Bilimoria, et al, NEJM 2016

Perceptions of PATIENT CARE 26% STANDARD Patient Safety P<0.001 FLEXIBLE 13% 56% Continuity of STANDARD Care FLEXIBLE 19% OR 0.16 (95%CI 0.12 - 0.21); P<0.001 0% 10% 20% 30% 40% 50% 60% Percent Perceiving Negative Effect

Breaks in Continuity of Care STANDARD Leave during an operation due to duty 13% Leave During an Operation hour regulations Due to Duty Hour Regulations FLEX 7% OR 0.46 (95%CI 0.32 - 0.65); P<0.001 Miss an operation due to duty hour Miss an Operation 42% STANDARD Due to Duty Hour Regulations regulations 30% FLEXIBLE OR 0.56 (95%CI 0.45 - 0.69); P<0.001 Handoff an active patient issue due to 46% STANDARD Hand Off an Active Patient Care Issue duty hour regulations Due to Duty Hour Regulations 32% FLEXIBLE OR 0.53 (95%CI 0.45 - 0.63); P<0.001 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Event Occurred at Least Once in the Last Month

STANDARD 14% Job Satisfaction FLEXIBLE 13% Perceptions of Well-being STANDARD 9% Career choice satisfaction FLEXIBLE 9% STANDARD 16% Morale 17% FLEXIBLE STANDARD 9% Time with family and friends* FLEXIBLE 25% STANDARD 9% Time for extracurricular activities* 26% FLEXIBLE STANDARD 9% Rest* FLEXIBLE 26% STANDARD 7% Health* 18% FLEXIBLE 0% 5% 10% 15% 20% 25% 30% Percent Perceiving Negative Effect

Well-Being by PGY Level 25% Health Rest 40% Percent Perceiving Negative Effect Percent Perceiving Negative Effect 35% 20% 30% 15% 25% 20% 10% 15% 10% 5% 5% 0% 0% PGY1 PGY2-3 PGY4-5 PGY1 PGY2-3 PGY4-5 Standard Flexible Standard Flexible 16% Overall Well-being 40% Time for Family/Friends 14% Percent Perceiving Negative Effect 35% 12% Percent Dissatisfied 30% 10% 25% 8% 20% 6% 15% 4% 10% 2% 5% 0% 0% PGY1 PGY2-3 PGY4-5 PGY1 PGY2-3 PGY4-5 Yang/ Bilimoria, et al, Standard Flexible Standard Flexible JACS 2017

Resident Safety • Motor vehicle accidents • Near-miss accidents No difference between study • Needle sticks arms • Fatigue-related errors

Resident Preference for Flexibility 100 Only 14% prefer standard policies 90 80 % Who Prefer Flexibility / Neutral 70 60 50 40 30 20 10 0 Standard Flexible Policy Standard Flexible Policy Standard Flexible Policy Standard Flexible Policy Policy Policy Policy Policy ALL RESIDENTS PGY1 PGY2-3 PGY4-5 Prefer Flexible Policy Neutral Yang/ Bilimoria, JACS 2017

Limitations • Limited to programs affiliated with ACS NSQIP hospitals • Unclear how flexible policies might affect training and experience long term • Patient outcomes were limited to those included in ACS NSQIP • Results may not be generalizable to non- surgical specialties

Conclusions • Safe for patient care • Improved continuity of care • Numerous educational/training benefit • Residents understand the tradeoff

The Opposition

Can New York Participate? • Duty hours attached to state laws • NY programs desperate to participate • Sought waiver from NY Health Commissioner • Introduced legislation to allow FIRST Trial ( S71763-2013 ) – Passed committee and Senate • Meetings with Assembly members

“New York does not need to subject its patients or its physicians to future studies that may well put both in harm’s way in order to learn from future national studies.”

Public Citizen/AMSA/SEIU Complaints • No equipoise • IRB determination • No complaints from during FIRST

iCOMPARE Study • Internal medicine • Uses FIRST Trial study design • Runs July 2015 to June 2016 • Uses Medicare data for outcome measurement • Results in late 2018

ACGME Policy Change Process ACGME Duty Hours Task Force October 7-8, 2016 Public Comment Period December 2016 ACGME Board February 2017

Changes for Flexible Policy Arm 2011 Policies Waived in FIRST ACGME Policy Change Maximum of 24 hours duty with an Same, but can stay longer additional 4 hours for transitions in PRN if for single patient and care resident’s choice At least 8-10 hours off after a regular Eliminated shift PGY-1 resident duty periods must not Eliminated exceed 16 hours Residents must have 14 hours off Retained after 24 hours in-house duty

What’s Next for Duty Hours? • Ensure patient and resident safety • Assess long-term success of trainees • Move on to more important ways to ensure safe, excellent care at teaching hospitals