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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Safety, Education, Medical, Sleep

Intervention / Treatment
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* Behavioral: Flexible Duty Hour Schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to: Randomization to one of the two study arms. 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 Allow access and analysis of de-identified resident duty hour adherence data/logs, call schedules, and rotation schedules to the Study Team. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Duty Hour Schedule<br>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<br>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<br>* 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)<br>|

What is the study measuring?
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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 |