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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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This study will consist of a randomized controlled trial in which the investigators test the feasibility and effectiveness of mandatory nap programs for physicians in training. One site will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The other will be the oncology service of the Hospital of the University of Pennsylvania. The primary outcome will be the amount slept while on call. The first year will test the efficacy of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour mandatory nap schedule.
Background: The release of the Institute of Medicine report on resident work hours and patient safety highlighted the risks to patient and resident safety of extended duty on-call shifts.
Objectives: The purpose of this study is to test the feasibility and effectiveness of mandatory naps during extended duty overnight shifts for residents.
Methods: For each site (PVAMC and HUP), every other month residents will be randomized to either work the standard schedule (which involves interns being on duty for 30 continuous hours) vs. the mandatory nap schedule, which involves interns signing out their beepers for 5 hours in the middle of the night to covering night floats and for 3 hours in Year 2. The primary outcome will be the amount slept as measured by actigraphs, with secondary outcomes of cognitive alertness measured by 3-minute psychomotor vigilance testing (PVT), Stanford sleepiness Scale, and other measures of resident and patient well-being.
Status: Recruitment complete, analyses phase only
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Schedule | No Intervention | interns work standard schedule, being on duty for 30 continuous hours | |
| Mandatory Naps | Experimental | interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandatory Naps | Behavioral | As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am |
| Measure | Description | Time Frame |
|---|---|---|
| Hours Slept on Overnight Extended Duty Call Shifts | Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin G. Volpp, MD PhD | VA Medical Center, Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23212498 | Result | Volpp KG, Shea JA, Small DS, Basner M, Zhu J, Norton L, Ecker A, Novak C, Bellini LM, Dine CJ, Mollicone DJ, Dinges DF. Effect of a protected sleep period on hours slept during extended overnight in-hospital duty hours among medical interns: a randomized trial. JAMA. 2012 Dec 5;308(21):2208-17. doi: 10.1001/jama.2012.34490. | |
| 21492159 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Schedule | interns work standard schedule, being on duty for 30 continuous hours |
| FG001 | Mandatory Naps | interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am. Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
| |||||||||||||
| Year 2 |
|
Characteristics of control and intervention groups comprised of medicine interns participating in a randomized trial of a Year 1 5-hour and Year 2 3-hour protected nap period at the Philadelphia Veterans Administration Medical Center ( PVAMC) and the Hospital of the University of Pennsylvania
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Schedule | interns work standard schedule, being on duty for 30 continuous hours |
| BG001 | Mandatory Naps | interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am. Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hours Slept on Overnight Extended Duty Call Shifts | Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2. | Posted | Mean | 95% Confidence Interval | hours | 12 months | Days studied | Participants |
|
Adverse event data was collected from time of first shift of intern or resident through the end of the year study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - Standard Schedule | interns work standard schedule, being on duty for 30 continuous hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Volpp, MD, PhD | Center for Health Incentives and Behavioral Economics | 215.573-0270 | volpp70@exchange.upenn.edu |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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|
| Halpern SD, Kohn R, Dornbrand-Lo A, Metkus T, Asch DA, Volpp KG. Lottery-based versus fixed incentives to increase clinicians' response to surveys. Health Serv Res. 2011 Oct;46(5):1663-74. doi: 10.1111/j.1475-6773.2011.01264.x. Epub 2011 Apr 14. |
| 24448046 | Result | Shea JA, Dinges DF, Small DS, Basner M, Zhu J, Norton L, Ecker AJ, Novak C, Bellini LM, Dine CJ, Mollicone DJ, Volpp KG. A randomized trial of a three-hour protected nap period in a medicine training program: sleep, alertness, and patient outcomes. Acad Med. 2014 Mar;89(3):452-9. doi: 10.1097/ACM.0000000000000144. |
| 28329124 | Derived | Basner M, Dinges DF, Shea JA, Small DS, Zhu J, Norton L, Ecker AJ, Novak C, Bellini LM, Volpp KG. Sleep and Alertness in Medical Interns and Residents: An Observational Study on the Role of Extended Shifts. Sleep. 2017 Apr 1;40(4):zsx027. doi: 10.1093/sleep/zsx027. |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | Arm 2 - Mandatory Naps | interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am. Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am | 0 | 172 | 0 | 172 |
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| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |