Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
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Purpose
This study will test the feasibility and effectiveness of protected time for physicians in training during 30 hour shifts in a medical intensive care unit. The primary outcome will be fatigue. Secondary outcomes include the amount slept while on call, depression, and burnout.
| Condition | Intervention | Phase |
|---|---|---|
|
Fatigue Sleep Deprivation Depression |
Behavioral: Protected time and Dedicated time |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | A Prospective Cohort Study on the Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts |
- Fatigue as measured by daytime multiple sleep latency test. [ Time Frame: Once, during last week of intervention. ] [ Designated as safety issue: Yes ]
- Hours slept during protected time [ Time Frame: Once, during last week of intervention ] [ Designated as safety issue: No ]
- Depression [ Time Frame: Once, during last week of intervention ] [ Designated as safety issue: No ]
- Burnout [ Time Frame: Once, during last week of intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Protected Time Group
Interns working 30 hour shifts every 3rd night and an average of 80 hours per week in a medical intensive care unit.
|
Behavioral: Protected time and Dedicated time
On Sunday through Thursday nights medical intensive care unit interns will have a 5 hour protected period from 2 to 7 am. During this time they will relinquish their pager and cell phone to the Night Float PGY2 or PGY3 who is already responsible for the ICU patients. The four hours between 2 and 6 am are entirely protected. 6 AM to 7 AM is dedicated time during which the interns will be expected to start pre-rounding on the ICU patients and to begin progress notes for the remaining members of the ICU team but still have no pager, cell phone, or cross coverage duties. On Friday and Saturday nights there will be no protected time but these interns will have 42 consecutive hours off following their extended shifts.
Other Name: Nap
|
Detailed Description:
Background: The Institute of Medicine has proposed 5 hour naps for residents on extended overnight call-duty shifts citing resident and patient safety. Concerns raised about this recommendation include increased handoffs, truncated continuity, and if residents would be able to effectively use the protected time for sleep.
Objectives: The purpose of this study is to test if protected time for sleep during extended duty overnight shifts improves resident fatigue and if they actually utilize the time for sleep.
Methods: All interns rotating through the medical intensive care unit from October 2009 through October 2010 will work extended shifts every 3rd night. On Sunday through Thursday nights they will have a 5 hour protected period from 2 AM to 7 AM. During this time they will relinquish their pager and cell phone to the Night Float PGY2 or PGY3 who is already responsible for the ICU patients. The four hours between 2 and 6 am are entirely protected. From 6 AM to 7 AM, interns will be expected to start computer rounding on the ICU patients and to begin progress notes for the remaining members of the ICU team but still have no pager, cell phone, or cross coverage duties. On Friday and Saturday nights there will be no protected time but these interns will have 42 consecutive hours off following their extended shift.
Results from the October 2009 to October 2010 protected time cohort of interns will be compared with two comparison groups from the same institution and the same medical intensive care unit during the academic year June 2008 to June 2009. The first comparison group is interns working 30 hour shifts every 3rd night without any protected time and an average of 80 hours per week. The second comparison group is interns working a maximum shift length of 16 hours and an average of 60 hours per week.
The primary outcome will be measurement of fatigue (daytime multiple sleep latency tests). Secondary outcomes include the amount slept as measured by actigraphy, assessment of burnout (Maslach Burnout Inventory) and depression (Beck Depression Inventory-II).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Interns in the Providence St. Vincent Medical Center Internal Medicine Residency Program who are rotating through the medical intensive care unit.
Exclusion Criteria:
- Refusal to consent to participate
Contacts and Locations| Contact: Michelle Sanders, M.D. | 503-216-2229 | michelle.sanders@providence.org |
| Contact: Gerald Dunlap, M.D. | 503-216-2229 | gerald.dunlap@providence.org |
| United States, Oregon | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| Principal Investigator: | Gerald Dunlap, M.D. | Internal Medicine Resident Program, Providence St. Vincent Medical Center |
| Study Director: | Michelle Sanders, M.D. | Internal Medicine Resident Program, Providence St. Vincent Medical Center |
| Principal Investigator: | Jay B Ham, M.D. | Internal Medicine Resident Program, Providence St. Vincent Medical Center |
| Study Director: | Jeffrely Bluhm, M.D. | Oregon Pulmonology Associates, Portland, Oregon |
More Information
Publications:
| Responsible Party: | Gerald Dunlap, M.D., Internal Medicine Resident Program, Providence St. Vincent Medical Center |
| ClinicalTrials.gov Identifier: | NCT00983008 History of Changes |
| Other Study ID Numbers: | 09-085B |
| Study First Received: | September 22, 2009 |
| Last Updated: | September 22, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Providence Health & Services:
|
Sleep Deprivation Signs and Symptoms Fatigue Internship and Residency Depression Medical Errors Burnout, Professional Burnout Actigraphy Personnel Staffing and Scheduling Workload |
Humans Adult Male Female Intensive Care Units Prospective Studies Work Schedule Tolerance Disorders of Excessive Somnolence Guideline Adherence Internal Medicine Education |
Additional relevant MeSH terms:
|
Sleep Deprivation Depression Depressive Disorder Fatigue Behavioral Symptoms Mood Disorders |
Mental Disorders Signs and Symptoms Dyssomnias Sleep Disorders Nervous System Diseases Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 21, 2013