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Completed

NCT Number: NCT02274818

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:
  • Randomization to one of the two study arms.
  • 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
  • Allow access and analysis of de-identified resident duty hour adherence data/logs, call schedules, and rotation schedules to the Study Team.
  • 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.

Treatment and study plan

Flexible Duty Hour Schedule

Behavioral

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of prolonged length of stay

    Time frame: 12 months

    Prolonged length of stay as measured by Medicare data

  2. Total costs of patient care

    Time frame: 12 months

    Total costs of patient care as measured by total Medicare payments

  3. Sleep duration (hours of sleep)

    Time frame: Measured daily for 14 days

    Sleep duration (hours of sleep) as measured with an actigraph

  4. Behavioral alertness

    Time frame: Measured daily for 14 days

    Behavioral alertness as measured with Psychomotor vigilance test

  5. Self perceived sleepiness

    Time frame: Measured daily for 14 days

    Self perceived sleepiness as measured by the Karolinska Sleepiness Score

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Brigham and Women's Hospital
  • Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: iCOMPARE

Important dates

Study start
2015
Primary completion
2016
Study completion
2020
First posted
Oct 24, 2014
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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