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Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education. (iCOMPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274818
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE October 20, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date September 4, 2020
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
30-day mortality [ Time Frame: 12 months ]
The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2016)
  • Rate of prolonged length of stay [ Time Frame: 12 months ]
    Prolonged length of stay as measured by Medicare data
  • Total costs of patient care [ Time Frame: 12 months ]
    Total costs of patient care as measured by total Medicare payments
  • Sleep duration (hours of sleep) [ Time Frame: Measured daily for 14 days ]
    Sleep duration (hours of sleep) as measured with an actigraph
  • Behavioral alertness [ Time Frame: Measured daily for 14 days ]
    Behavioral alertness as measured with Psychomotor vigilance test
  • Self perceived sleepiness [ Time Frame: Measured daily for 14 days ]
    Self perceived sleepiness as measured by the Karolinska Sleepiness Score
  • Time (hours per day) spent in direct patient care [ Time Frame: measured daily over 2-4 wks ]
    Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern
  • Trainee satisfaction with education [ Time Frame: measured at baseline and at end of intervention year ]
    Self-reported satisfaction with education as assessed thru survey questions
  • Program director satisfaction with trainee education [ Time Frame: measured at baseline and end of intervention year ]
    Self-reported satisfaction with trainee education as assessed thru survey questions
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.
Official Title  ICMJE Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
Brief Summary

The investigators are conducting a cluster randomized trial in a sample of 63 internal medicine (IM) training programs that are randomly assigned to either the current duty hour standards or less restricted flexible duty hour standards.

The trial includes a main protocol in which all randomized IM programs participate and two substudies. "Time and Motion" and "Sleep and Alertness", each conducted at a subset of IM programs and focusing on more detailed data collection at the intern level.

The main protocol will examine patient safety and costs as well as quality of education. The "Time and Motion" substudy examines additional educational outcomes. The "Sleep and Alertness" substudy examines intern sleep time and alertness.

Detailed Description

Title: Sleep duration (hours of sleep) as measured with an actigraph Time frame: Measured daily for 14 days

Title: Behavioral alertness as measured with Psychomotor vigilance test Time frame: Measured daily for 14 days

Title: Self perceived sleepiness as measured by the Karolinska Sleepiness Score Time frame: Measured daily for 14 days

Title: Time (hours per day) spent in direct patient care Description: Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern Time frame: measured daily over 2-4 wks

Title: Trainee satisfaction with education Description: Self-reported satisfaction with education as assessed thru survey questions Time frame: measured at baseline and at end of intervention year

Title: Program director satisfaction with trainee education Description: Self-reported satisfaction with trainee education as assessed thru survey questions Time frame: measured at baseline and end of intervention year

Patient safety and costs:

Title: Total costs of patient care as measured by total Medicare payments Time frame: Measured over year of trial

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Safety
  • Education, Medical
  • Sleep
Intervention  ICMJE Behavioral: Flexible Duty Hour Schedule

IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:

  • No more than 80 hours of work per week (when averaged over 4 weeks)
  • 1 day off in 7 (when averaged over 4 weeks)
  • In-house call no more frequently than every 3rd night (when averaged over 4 weeks)
Study Arms  ICMJE
  • No Intervention: Standard Duty Hour Schedule
    IM programs randomized to the currently mandated duty 16 hour standards (maximum work duration of 16 hours for interns and 28 hours for PGY2-3); this schedule may involve night float.
  • Experimental: Flexible Duty Hour Schedule

    IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:

    • No more than 80 hours of work per week (when averaged over 4 weeks)
    • 1 day off in 7 (when averaged over 4 weeks)
    • In-house call no more frequently than every 3rd night (when averaged over 4 weeks)
    Intervention: Behavioral: Flexible Duty Hour Schedule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
3500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:

    1. Randomization to one of the two study arms.
    2. Develop, and share with the study team, institutional duty hour schedules and regulatory policies/procedures that will ensure adherence to, and enforcement of, the duty hour regulations that apply to their study arm
    3. Allow access and analysis of de-identified resident duty hour adherence data/logs, call schedules, and rotation schedules to the Study Team.
    4. Participate, and encourage trainee participation at your institution, in beginning and end of year iCOMPARE surveys.

Exclusion Criteria:

  • The investigators excluded 119 programs that comprise the bottom 50% in resident-to-bed ratio and the bottom 25% in patient volume related to the diagnoses by which the patient population will be selected for evaluation of safety outcomes.
  • Within the 260 programs that remain, the investigators excluded the 65 in the lowest quartile of program size to ensure we can feasibly obtain sufficient trainee measurements.
  • The 195 remaining programs are eligible for inclusion.
  • The investigators have also excluded children and VA hospitals.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02274818
Other Study ID Numbers  ICMJE IRB00051227
1U01HL125388 ( U.S. NIH Grant/Contract )
1U01HL126088 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: David Asch, MD, MBA University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP