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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Safety; Education, Medical
• Intervention / Treatment: Behavioral: Flexible Duty Hour Schedule

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 Type: Interventional
• Enrollment (Actual): 3500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Johns Hopkins University; National Heart, Lung, and Blood Institute (NHLBI); Brigham and Women's Hospital
• Investigators: Principal Investigator: David Asch, MD, MBA, University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00051227; 1U01HL125388 (U.S. NIH Grant/Contract); 1U01HL126088 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO