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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Providence Health & Services.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00983008
First received: September 22, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 22, 2009
September 22, 2009
October 2009
November 2010   (final data collection date for primary outcome measure)
Fatigue as measured by daytime multiple sleep latency test. [ Time Frame: Once, during last week of intervention. ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
A Prospective Cohort Study on the Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts

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.

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).

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Fatigue
  • Sleep Deprivation
  • Depression
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
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.
Intervention: Behavioral: Protected time and Dedicated time

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
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
 
NCT00983008
09-085B
No
Gerald Dunlap, M.D., Internal Medicine Resident Program, Providence St. Vincent Medical Center
Providence Health & Services
Not Provided
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
Providence Health & Services
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP