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

NCT02274818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2020-09-04

No results posted yet for this study

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.

Conditions

  • Safety
  • Education, Medical
  • Sleep

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • David Asch, MD, MBA · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-12-31
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02274818 on ClinicalTrials.gov