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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HL125388 | U.S. NIH Grant/Contract | View source | |
| 1U01HL126088 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Brigham and Women's Hospital | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Duty Hour Schedule | No Intervention | 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. | |
| Flexible Duty Hour Schedule | Experimental | IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexible Duty Hour Schedule | Behavioral | IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:
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| 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 |
| 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 |
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Inclusion Criteria:
Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Asch, MD, MBA | University of Pennsylvania | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985861 | Derived | 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. | |
| 30855741 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2015 | Oct 3, 2018 | Prot_SAP_000.pdf |
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| 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 |
| 30855740 | Derived | 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. |
| 30244209 | Derived | 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. |
| 29557719 | Derived | 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. |