Education, Medical, Safety, Sleep
Conditions
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
Interventions
BEHAVIORALFlexible 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)
Sponsors
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 12 months | The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep duration (hours of sleep) | Measured daily for 14 days | Sleep duration (hours of sleep) as measured with an actigraph |
| Behavioral alertness | Measured daily for 14 days | Behavioral alertness as measured with Psychomotor vigilance test |
| Self perceived sleepiness | Measured daily for 14 days | Self perceived sleepiness as measured by the Karolinska Sleepiness Score |
| Total costs of patient care | 12 months | Total costs of patient care as measured by total Medicare payments |
| Time (hours per day) spent in direct patient care | 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 | 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 | measured at baseline and end of intervention year | Self-reported satisfaction with trainee education as assessed thru survey questions |
| Rate of prolonged length of stay | 12 months | Prolonged length of stay as measured by Medicare data |
Outcome results
None listed