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

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

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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,

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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

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Major SOQIC Initiatives

  • 55 Hospitals
  • Novel approaches to spur quality improvement
  • Platform for QI trials / improvement science

The FIRST Trial

Flexibility In duty hour Requirements for Surgical Trainees

  • 152 Hospitals
  • National trial of policy intervention
  • P4P measure and program evaluations
  • Influencing policy
  • NMH quality initiatives
  • System Surgical Collaborative
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Disclosures: FIRST Trial Funding

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Public Pressure to Regulate Duty Hours

  • Resident union
  • Public interest groups
  • Patient and Physician Safety and Protection Act

– 2001, 2003, 2005

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Reforms of 2003

“…political backdrop in which groups pursued federal intervention to regulate resident hours…”

  • 80 hours
  • 1 in 7 days off
  • 1 in 3 call
  • 24+4 hour limit
  • 8-10 hours off between shifts

ACGME 2003

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Ann Rev Med, 2012

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

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2008 IOM Report

e

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Reforms of 2011

  • 16 hours for interns
  • 14 hours off after 24h call
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2 4 6 8 10 12 1 2 3 4 5 6 7 8

Risk-adjusted rate, %

Death or Serious Morbidity July 2009 July 2013

Time (in 6-month Intervals) 2011 Duty Hour Changes OR (95% CI): 1.06 (0.94-1.20), P=0.35

Rajaram/Bilimoria, JAMA Dec 2014

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European Working Time Directive

  • 2009
  • 48 hours per week
  • 13h per day
  • 20 min break q6h
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No Large Randomized Trials

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

#FirstTrialSurgery

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Pragmatic Cluster Randomized Trial

Surgical Residency Programs/Hospitals Flexible Policy Standard Policy Randomize Hospitals/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

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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

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Duty Hour Requirements - No Change

STANDARD POLICY FLEXIBLE POLICY 80 hours per week

(averaged over 4 weeks)

NO CHANGE One day off per week

(averaged over 4 weeks)

NO CHANGE Call no more frequently than every 3rd night NO CHANGE

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Changes for Flexible Policy Arm

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

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Study Arm Comparisons

TOTAL Standard Policy Flexible 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

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Patient Outcomes

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Comparison of Patient Outcomes: Primary Outcome

N=138,691

Favors FLEXIBLE Policy Favors STANDARD Policy

Death/Serious Morbidity

Odds Ratio

Adjusted Unadjusted

NONINFERIOR

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Comparison of Patient Outcomes: Secondary Outcomes

Favors FLEXIBLE Policy Favors STANDARD Policy

Death Serious Morbidity Any Morbidity Failure-to-Rescue Pneumonia Renal Failure Reoperation Sepsis SSI UTI

UNADJUSTED ADJUSTED

Bilimoria, et al, NEJM 2016

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Subgroup Analyses

  • Emergency surgery
  • High-risk patients
  • Inpatients
  • Resident involvement

No difference between study arms for any outcome

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Resident Outcomes

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Resident-Reported Primary Outcomes

15% 11% 12% 11%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Overall wellbeing N=3,645 Overall resident education quality N=3,642

Percent Dissatisfied

1.08 (0.77-1.52); P=0.64 1.31 (0.99-1.74); P=0.06 STANDARD STANDARD FLEXIBLE FLEXIBLE

Bilimoria, et al, NEJM 2016

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Perceptions of PATIENT CARE

26% 56% 13% 19%

0% 10% 20% 30% 40% 50% 60%

Patient Safety Continuity of Care

Percent Perceiving Negative Effect

P<0.001 OR 0.16 (95%CI 0.12 - 0.21); P<0.001 FLEXIBLE STANDARD FLEXIBLE STANDARD

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Breaks in Continuity of Care

13% 42% 46% 7% 30% 32%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%

Leave during an operation due to duty hour regulations Miss an operation due to duty hour regulations Handoff an active patient issue due to duty hour regulations

Event Occurred at Least Once in the Last Month

FLEXIBLE STANDARD

Miss an Operation Due to Duty Hour Regulations Leave During an Operation Due to Duty Hour Regulations OR 0.46 (95%CI 0.32 - 0.65); P<0.001

FLEXIBLE STANDARD FLEX STANDARD

Hand Off an Active Patient Care Issue Due to Duty Hour Regulations OR 0.56 (95%CI 0.45 - 0.69); P<0.001 OR 0.53 (95%CI 0.45 - 0.63); P<0.001

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14% 9% 16% 9% 9% 9% 7% 13% 9% 17% 25% 26% 26% 18%

0% 5% 10% 15% 20% 25% 30%

Job Satisfaction Career choice satisfaction Morale Time with family and friends* Time for extracurricular activities* Rest* Health*

Percent Perceiving Negative Effect

FLEXIBLE FLEXIBLE FLEXIBLE FLEXIBLE FLEXIBLE FLEXIBLE FLEXIBLE STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

Perceptions of Well-being

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0% 2% 4% 6% 8% 10% 12% 14% 16% PGY1 PGY2-3 PGY4-5

Percent Dissatisfied

Standard Flexible

Well-Being by PGY Level

0% 5% 10% 15% 20% 25% PGY1 PGY2-3 PGY4-5

Percent Perceiving Negative Effect

Standard Flexible

Health

0% 5% 10% 15% 20% 25% 30% 35% 40% PGY1 PGY2-3 PGY4-5

Percent Perceiving Negative Effect

Standard Flexible

Rest

0% 5% 10% 15% 20% 25% 30% 35% 40% PGY1 PGY2-3 PGY4-5

Percent Perceiving Negative Effect

Standard Flexible

Time for Family/Friends Overall Well-being

Yang/ Bilimoria, et al, JACS 2017

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Resident Safety

  • Motor vehicle accidents
  • Near-miss accidents
  • Needle sticks
  • Fatigue-related errors

No difference between study arms

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Resident Preference for Flexibility

10 20 30 40 50 60 70 80 90 100 Standard Policy Flexible Policy Standard Policy Flexible Policy Standard Policy Flexible Policy Standard Policy Flexible Policy ALL RESIDENTS PGY1 PGY2-3 PGY4-5

% Who Prefer Flexibility / Neutral

Prefer Flexible Policy Neutral

Only 14% prefer standard policies

Yang/ Bilimoria, JACS 2017

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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

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Conclusions

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

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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
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“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

  • rder to learn from future national studies.”
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Public Citizen/AMSA/SEIU Complaints

  • No equipoise
  • IRB determination
  • No complaints

from during FIRST

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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
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ACGME Policy Change Process

ACGME Duty Hours Task Force ACGME Board

October 7-8, 2016 February 2017

Public Comment Period

December 2016

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Changes for Flexible Policy Arm

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

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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

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Acknowledgements

  • Northwestern University

– Karl Y. Bilimoria, MD MS – Jeanette W. Chung, PhD – Larry V. Hedges, PhD – Allison R. Dahlke, MPH – Remi Love, BS – Anthony D. Yang, MD – David M. Mahvi, MD – David D. Odell, MD MMSc – Jonah J. Stulberg, MD PhD MPH – Jonathan Fryer MD – Anne Grace PhD – Julie K. Johnson PhD – Lindsey J. Kreutzer MPH – Shari Meyerson MD – Emily S. Pavey MA – Sean Perry JD – Christopher M. Quinn MS – Ravi Rajaram MD MS

  • University of Pennsylvania

– Judy Shea PhD – Rachel R. Kelz, MD MSCE

  • Vanderbilt University

– John L. Tarpley, MD

  • University of Chicago

– Mitchell Posner MD

  • American College of Surgeons

– Mark E. Cohen, PhD – David B. Hoyt, MD – Clifford Y. Ko, MD MS MSHS – Sameera Ali MPH – Amy Hart BS – Emma Malloy BA – Brian Matel BA – Craig Miller BSEE – Lynn Modla MS – Ajit Sachdeva MD – Lynn Zhou PhD

  • University of Vermont

– James Hebert MD

  • University of Michigan

– Michael Englesbe MD MPH – Paul Gauger MD

  • Massachusetts General Hospital

– Christine V. Kinnier MD MS

  • University of Tennessee, Chatanooga

– Joseph Cofer MD

  • University of Wisconsin

– Eugene Foley MD

  • Johns Hopkins

– Thomas Louis PhD

  • American Board of Surgery

– Frank R. Lewis, MD – Thomas Biester MS – Andrew Jones PhD

  • Accreditation Council for Graduate

Medical Education

– Thomas Nasca MD – John Potts MD – Paige Amidon – Rebecca Miller MS

  • Defense Health Agency

– Margaret M. Class

  • ACS NSQIP Surgeon

Champions and Surgical Clinical Reviewers from 151 participating hospitals

  • Program Directors and

Program Coordinators at 117 participating General Surgery residency programs

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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 for Quality, Department of Surgery Feinberg School of Medicine, Northwestern University

@kbilimoria