- Purpose and Goals of the Trial
- Program Responsibilities
- Frequently-asked Questions
- Assess Eligibility / Request Application
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PURPOSE AND GOALS OF THE TRIAL
We are proposing to conduct a systematic, large-scale cluster randomized trial comparing the current duty-hour regimen (16 hour maximum) against a regimen with a longer shift length that includes a protected night sleep period (28 hour maximum). The goal of iCOMPARE is to provide evidence to help policy makers evaluate whether the duty hour standards that limit consecutive work hours for interns should be changed.
Click Here For Details DESIGN SUMMARY
iCOMPARE is a two-year crossover study that will randomly assign approximately 40 ACGME-accredited Internal Medicine training programs to one of two duty-hour regimens:
- 16 for year 1, followed by 28PS for year two; or
- 28PS for year 1, followed by 16 for year two
16 is a duty-hour regimen that conforms to current ACGME requirements including a 16-hour maximum shift length
28PS is a new duty-hour regimen with a 28-hour maximum shift length that includes a mandated 4-hour period of protected sleep at night
Outcomes include measures of trainee sleep, trainee education, and patient safety. Planned substudies will include actigraphy and time-in-motion analyses conducted in a subset of the enrolled training programs.
Click Here For Details RECRUITMENT
The iCOMPARE team will recruit Internal Medicine training programs that meet certain pre-specified eligibility criteria for participation. Interested programs may check whether they appear to meet these eligibility criteria by visiting the iCOMPARE Request an Application page (link below). Interested programs that do not appear to meet those criteria may still complete the Request an Application form, providing as much information as possible, so that the iCOMPARE team can reassess eligibility. Eligiblity criteria are based on program size, hospital resident-to-bed ratio, and hospital patient volumes in diagnosis groups being measured.
|Apr 06, 2014:||Begin soliciting interested programs; assess eligibility|
|May 01, 2014:||Begin distributing applications to interested and eligible programs|
|Jul 01, 2014:||Last date for programs to apply|
|Aug 01, 2014:||Programs selected for participation notified|
|Sep 15, 2014:||Participation agreements finalized|
|Oct 01, 2014:||Programs notified of duty-hour regimen order|
|Jul 01, 2015:||Programs begin first duty-hour regimen (Year 1)|
|Jul 01, 2016:||Programs begin second duty-hour regimen (Year 2)|
|Jun 30, 2017:||Program participation ends|
Click Here For Details PROGRAM RESPONSIBILITIES
Training programs that participate in the iCOMPARE study will agree to a number of important responsibilities, including:
- Commitment to participate for both study years (2015-16 and 2016-17)
- Adhere to the assigned duty-hour schedule
- Designate an iCOMPARE coordinator
- Provide iCOMPARE fatigue and sleep management programs to trainees
- Provide or permit access to necessary data to assess eligibility, adherence, and outcomes
- Participate in regular iCOMPARE conference calls
- Encourage timely completion of surveys by trainees, core faculty, and Program Directors
Participating programs will be provided stipends to help offset iCOMPARE expenses. Trainees at participating programs will be provided small incentives for completion of surveys.
Programs that agree to participate in the Sleep Substudy or the Time-In-Motion Substudy will have additional responsibilities and will recieve additional financial support.
iCOMPARE is led by investigators from the University of Pennsylvania, Johns Hopkins University, and the Brigham and Women's Hospital/Harvard Medical School. The study is contingent upon receiving funding, with a decision expected during the summer of 2014.
The ACGME has approved waivers of the duty-hour standards for programs that participate in iCOMPARE.
Click Here For Details FREQUENTLY ASKED QUESTIONS
Click here for a list of detailed questions-and-answers about the iCOMPARE study.
Request an Application ASSESS ELIGIBILITY / REQUEST APPLICATION
iCOMPARE will select training programs to participate from a list of eligible programs that apply to join the study. Elgibility may be determined in two ways:
- Many programs have been pre-determined to be eligible based on data available from the ACGME and CMS
- Some programs that have not be pre-determined to be eligible may still request an eligibility assessment by providing more recent data to the iCOMPARE team
In both cases, interested programs should request an application by visiting the Request an Application page and supplying as much information as possible. Ideally, this request will be supplied by the Program Director.
The Request an Application page also contains information about which programs have been pre-determined to be eligible.