NCT02274818|CompletedDMC
Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.
iCOMPARE
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iCOMPARE
Sponsor study identifier
Secondary identifiers
NIH
NIH
interventional
3,500
0 countries
N/A
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
June 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2014
Actual (reported)October 24, 2014
Actual (reported)July 2015
Date type not reportedThis date has not been verified as actual or estimated.
December 2016
Actual (reported)June 30, 2020
Actual (reported)30-day mortality
The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year
12 months
Rate of prolonged length of stay
12 months
Total costs of patient care
12 months
Sleep duration (hours of sleep)
Measured daily for 14 days
Behavioral alertness
Measured daily for 14 days
Self perceived sleepiness
Measured daily for 14 days
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.
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)
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
David Asch, MD, MBA
University of Pennsylvania
3,500 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2014
First Posted
October 24, 2014
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
Contact the study team to confirm eligibility.
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.
Primary Completion
December 2016
Actual (reported)Study Completion
June 30, 2020
Actual (reported)Last Updated
September 4, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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