Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts

Sponsor
Providence Health & Services (Other)
Overall Status
Terminated
CT.gov ID
NCT00983008
Collaborator
(none)
11
1
1
11
1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Protected time and Dedicated time
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
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
Actual Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Nap
  • Outcome Measures

    Primary Outcome Measures

    1. Fatigue as measured by daytime multiple sleep latency test. [Once, during last week of intervention.]

    Secondary Outcome Measures

    1. Hours slept during protected time [Once, during last week of intervention]

    2. Depression [Once, during last week of intervention]

    3. Burnout [Once, during last week of intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Providence St. Vincent Medical Center Portland Oregon United States 97225

    Sponsors and Collaborators

    • Providence Health & Services

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michelle Schoepflin Sanders, Principal Investigator, Providence Health & Services
    ClinicalTrials.gov Identifier:
    NCT00983008
    Other Study ID Numbers:
    • 09-085B
    First Posted:
    Sep 23, 2009
    Last Update Posted:
    Sep 26, 2019
    Last Verified:
    Sep 1, 2019

    Study Results

    No Results Posted as of Sep 26, 2019