Status:
COMPLETED
Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Safety
Education, Medical
Eligibility:
All Genders
18+ years
Phase:
NA
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 rest...
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: Measure...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT02274818
Start Date
July 1 2015
End Date
June 30 2020
Last Update
September 4 2020
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