Overview

This trial is active, not recruiting.

Conditions safety, education, medical, sleep
Treatment flexible duty hour schedule
Sponsor University of Pennsylvania
Collaborator Johns Hopkins University
Start date July 2015
End date December 2016
Trial size 3500 participants
Trial identifier NCT02274818, 1U01HL125388, 1U01HL126088, IRB00051227

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
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)
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)
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)

Primary Outcomes

Measure
30-day mortality
time frame: 12 months

Secondary Outcomes

Measure
Rate of prolonged length of stay
time frame: 12 months
Total costs of patient care
time frame: 12 months
Sleep duration (hours of sleep)
time frame: Measured daily for 14 days
Behavioral alertness
time frame: Measured daily for 14 days
Self perceived sleepiness
time frame: Measured daily for 14 days
Time (hours per day) spent in direct patient care
time frame: measured daily over 2-4 wks
Trainee satisfaction with education
time frame: measured at baseline and at end of intervention year
Program director satisfaction with trainee education
time frame: measured at baseline and end of intervention year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
Principal investigator David Asch, MD, MBA
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.