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In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention cohort | Experimental | This cohort will work on the SCS intervention schedule |
|
| Control cohort | No Intervention | This group will work on a traditional schedule |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCS intervention schedule | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| resident-related preventable adverse events and near misses. | PGY2&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule;(primary endpoints: resident-related preventable adverse events and near misses) | Each resident (subject) will be observed for 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU-wide preventable adverse events and near misses | Rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule. | Each participating PICU will be studied for 8 months on each of the schedules (16 months total). |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Landrigan, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Charles A Czeisler, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Colorado | Aurora | Colorado | 80045 | United States | ||
| University of Iowa Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33619044 | Derived | Rahman SA, Sullivan JP, Barger LK, St Hilaire MA, O'Brien CS, Stone KL, Phillips AJK, Klerman EB, Qadri S, Wright KP Jr, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Sanderson AL, Zee PC, Landrigan CP, Czeisler CA, Lockley SW; ROSTERS STUDY GROUP. Extended Work Shifts and Neurobehavioral Performance in Resident-Physicians. Pediatrics. 2021 Mar;147(3):e2020009936. doi: 10.1542/peds.2020-009936. Epub 2021 Feb 22. | |
| 32579812 |
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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 | Jun 12, 2015 | Apr 19, 2019 | Prot_SAP_000.pdf |
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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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| resident neurobehavioral performance. | Resident physicians' risk of neurobehavioral performance failures as assessed through simple visual reaction time tasks [Psychomotor Vigilance Task (PVT) lapses] - will be lower on the SCS intervention schedule than on the traditional schedule. | Subjects will be tested 3-5 times per week for 1 month. |
| Risk of resident motor vehicle crashes (MVC) | Fatigue during the commute to and from work, as assessed by the John's drowsiness scale (JDS), will be lower on the SCS schedule than the traditional schedule, making MVC's less likely during the time on the SCS schedule. | Subjects will be monitored while they drive to/from work for 1 month. |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Childrens Hospital Boston | Boston | Massachusetts | 02115 | United States |
| Cincinnati Childrens Hospital | Cincinnati | Ohio | 45229-3026 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22911 | United States |
| Seattle Children's Hospital | Seattle | Washington | United States |
| Derived |
| Landrigan CP, Rahman SA, Sullivan JP, Vittinghoff E, Barger LK, Sanderson AL, Wright KP Jr, O'Brien CS, Qadri S, St Hilaire MA, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee PC, Lockley SW, Stone KL, Czeisler CA; ROSTERS Study Group. Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts. N Engl J Med. 2020 Jun 25;382(26):2514-2523. doi: 10.1056/NEJMoa1900669. |
| 31106381 | Derived | Barger LK, Sullivan JP, Blackwell T, O'Brien CS, St Hilaire MA, Rahman SA, Phillips AJK, Qadri S, Wright KP, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee P, Sanderson AL, Halbower AC, Lockley SW, Landrigan CP, Stone KL, Czeisler CA; ROSTERS Study Group. Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS). Sleep. 2019 Aug 1;42(8):zsz110. doi: 10.1093/sleep/zsz110. |
| 30885799 | Derived | Blackwell T, Kriesel DR, Vittinghoff E, O'Brien CS, Sullivan JP, Viyaran NC, Rahman SA, Lockley SW, Barger LK, Halbower AC, Poynter SE, Wright KP Jr, Yu PL, Zee PC, Landrigan CP, Czeisler CA, Stone KL; ROSTERS Study Group. Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study. Contemp Clin Trials. 2019 May;80:22-33. doi: 10.1016/j.cct.2019.03.005. Epub 2019 Mar 15. |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |