Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education. (iCOMPARE)
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ClinicalTrials.gov Identifier: NCT02274818 |
Recruitment Status :
Completed
First Posted : October 24, 2014
Last Update Posted : September 4, 2020
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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 or disease | Intervention/treatment | Phase |
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Safety Education, Medical Sleep | Behavioral: Flexible Duty Hour Schedule | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 3500 participants |
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). |
Study Start Date : | July 2015 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | June 30, 2020 |

Arm | Intervention/treatment |
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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.
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Experimental: Flexible Duty Hour Schedule
IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:
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Behavioral: Flexible Duty Hour Schedule
IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:
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- 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
- 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

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

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
Principal Investigator: | David Asch, MD, MBA | University of Pennsylvania |
Documents provided by University of Pennsylvania:
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT02274818 |
Other Study ID Numbers: |
IRB00051227 1U01HL125388 ( U.S. NIH Grant/Contract ) 1U01HL126088 ( U.S. NIH Grant/Contract ) |
First Posted: | October 24, 2014 Key Record Dates |
Last Update Posted: | September 4, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |