Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.
NCT ID: NCT02274818
Last Updated: 2020-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3500 participants
INTERVENTIONAL
2015-07-31
2020-06-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
No interventions assigned to this group
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)
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Brigham and Women's Hospital
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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David Asch, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
References
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Chaiyachati KH, Shea JA, Asch DA, Liu M, Bellini LM, Dine CJ, Sternberg AL, Gitelman Y, Yeager AM, Asch JM, Desai SV. Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations. JAMA Intern Med. 2019 Jun 1;179(6):760-767. doi: 10.1001/jamainternmed.2019.0095.
Basner M, Asch DA, Shea JA, Bellini LM, Carlin M, Ecker AJ, Malone SK, Desai SV, Sternberg AL, Tonascia J, Shade DM, Katz JT, Bates DW, Even-Shoshan O, Silber JH, Small DS, Volpp KG, Mott CG, Coats S, Mollicone DJ, Dinges DF; iCOMPARE Research Group. Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2019 Mar 7;380(10):915-923. doi: 10.1056/NEJMoa1810641.
Silber JH, Bellini LM, Shea JA, Desai SV, Dinges DF, Basner M, Even-Shoshan O, Hill AS, Hochman LL, Katz JT, Ross RN, Shade DM, Small DS, Sternberg AL, Tonascia J, Volpp KG, Asch DA; iCOMPARE Research Group. Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med. 2019 Mar 7;380(10):905-914. doi: 10.1056/NEJMoa1810642.
Shea JA, Silber JH, Desai SV, Dinges DF, Bellini LM, Tonascia J, Sternberg AL, Small DS, Shade DM, Katz JT, Basner M, Chaiyachati KH, Even-Shoshan O, Bates DW, Volpp KG, Asch DA; iCOMPARE Research Group. Development of the individualised Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial: a protocol summary of a national cluster-randomised trial of resident duty hour policies in internal medicine. BMJ Open. 2018 Sep 21;8(9):e021711. doi: 10.1136/bmjopen-2018-021711.
Desai SV, Asch DA, Bellini LM, Chaiyachati KH, Liu M, Sternberg AL, Tonascia J, Yeager AM, Asch JM, Katz JT, Basner M, Bates DW, Bilimoria KY, Dinges DF, Even-Shoshan O, Shade DM, Silber JH, Small DS, Volpp KG, Shea JA; iCOMPARE Research Group. Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2018 Apr 19;378(16):1494-1508. doi: 10.1056/NEJMoa1800965. Epub 2018 Mar 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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