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

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ClinicalTrials.gov Identifier: NCT02274818

Recruitment Status : Completed

First Posted : October 24, 2014

Last Update Posted : September 4, 2020

Sponsor:

Collaborators:

Johns Hopkins University

National Heart, Lung, and Blood Institute (NHLBI)

Brigham and Women's Hospital

Information provided by (Responsible Party):

University of Pennsylvania

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Safety Education, Medical Sleep	Behavioral: Flexible Duty Hour Schedule	Not Applicable

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: 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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
Study Start Date :	July 2015
Actual Primary Completion Date :	December 2016
Actual Study Completion Date :	June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety Safety

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 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.
Experimental: 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)	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)

Outcome Measures

Primary Outcome Measures :

30-day mortality [ Time Frame: 12 months ]
The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year

Secondary Outcome Measures :

Rate of prolonged length of stay [ Time Frame: 12 months ]
Prolonged length of stay as measured by Medicare data
Total costs of patient care [ Time Frame: 12 months ]
Total costs of patient care as measured by total Medicare payments
Sleep duration (hours of sleep) [ Time Frame: Measured daily for 14 days ]
Sleep duration (hours of sleep) as measured with an actigraph
Behavioral alertness [ Time Frame: Measured daily for 14 days ]
Behavioral alertness as measured with Psychomotor vigilance test
Self perceived sleepiness [ Time Frame: Measured daily for 14 days ]
Self perceived sleepiness as measured by the Karolinska Sleepiness Score
Time (hours per day) spent in direct patient care [ Time Frame: measured daily over 2-4 wks ]
Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern
Trainee satisfaction with education [ Time Frame: measured at baseline and at end of intervention year ]
Self-reported satisfaction with education as assessed thru survey questions
Program director satisfaction with trainee education [ Time Frame: measured at baseline and end of intervention year ]
Self-reported satisfaction with trainee education as assessed thru survey questions

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274818

Sponsors and Collaborators

University of Pennsylvania

Johns Hopkins University

National Heart, Lung, and Blood Institute (NHLBI)

Brigham and Women's Hospital

Investigators

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Principal Investigator:	David Asch, MD, MBA	University of Pennsylvania

Study Documents (Full-Text)

Documents provided by University of Pennsylvania:

Study Protocol and Statistical Analysis Plan [PDF] December 22, 2015

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: JAMA Intern Med. 2019 Jul 1;:null.

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.

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Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT02274818
Other Study ID Numbers:	IRB00051227 1U01HL125388 ( U.S. NIH Grant/Contract ) 1U01HL126088 ( U.S. NIH Grant/Contract )
First Posted:	October 24, 2014 Key Record Dates
Last Update Posted:	September 4, 2020
Last Verified:	September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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