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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02274818
First Posted: October 24, 2014
Last Update Posted: May 2, 2017
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.
Collaborators:
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose

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.


Condition Intervention
Safety Education, Medical Sleep Behavioral: Flexible Duty Hour Schedule

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 3500
Study Start Date: July 2015
Estimated Study Completion Date: June 2019
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274818


Sponsors and Collaborators
University of Pennsylvania
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Investigators
Principal Investigator: David Asch, MD, MBA University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02274818     History of Changes
Other Study ID Numbers: IRB00051227
1U01HL125388 ( U.S. NIH Grant/Contract )
1U01HL126088 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2014
First Posted: October 24, 2014
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No


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