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

Sleep Clinical Trial

— iCOMPARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274818
• Other study ID #: IRB00051227
• Secondary ID: 1U01HL1253881U01
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: June 30, 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Education, Medical
• Safety
• Sleep

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Brigham and Women's Hospital, Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of prolonged length of stay	Prolonged length of stay as measured by Medicare data	12 months
Secondary	Total costs of patient care	Total costs of patient care as measured by total Medicare payments	12 months
Secondary	Sleep duration (hours of sleep)	Sleep duration (hours of sleep) as measured with an actigraph	Measured daily for 14 days
Secondary	Behavioral alertness	Behavioral alertness as measured with Psychomotor vigilance test	Measured daily for 14 days
Secondary	Self perceived sleepiness	Self perceived sleepiness as measured by the Karolinska Sleepiness Score	Measured daily for 14 days
Secondary	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
Secondary	Trainee satisfaction with education	Self-reported satisfaction with education as assessed thru survey questions	measured at baseline and at end of intervention year
Secondary	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