Clinical trial NCT02274818: Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.
Official title: Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety
Education, Medical
Sleep
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Brigham and Women's Hospital
First posted: 2014-10-24
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility 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.

Primary outcomes:
measure: 30-day mortality
timeFrame: 12 months
Secondary outcomes:
measure: Rate of prolonged length of stay
timeFrame: 12 months
measure: Total costs of patient care
timeFrame: 12 months
measure: Sleep duration (hours of sleep)
timeFrame: Measured daily for 14 days
measure: Behavioral alertness
timeFrame: Measured daily for 14 days
measure: Self perceived sleepiness
timeFrame: Measured daily for 14 days
measure: Time (hours per day) spent in direct patient care
timeFrame: measured daily over 2-4 wks
measure: Trainee satisfaction with education
timeFrame: measured at baseline and at end of intervention year
measure: Program director satisfaction with trainee education
timeFrame: measured at baseline and end of intervention year
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: David Asch, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.