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
  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

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Fatigue as measured by daytime multiple sleep latency test. [ Time Frame: Once, during last week of intervention. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983008

Contacts
Contact: Michelle Sanders, M.D. 503-216-2229 michelle.sanders@providence.org
Contact: Gerald Dunlap, M.D. 503-216-2229 gerald.dunlap@providence.org

Locations
United States, Oregon
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
  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:
Signs and Symptoms
Fatigue
Sleep Deprivation
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:
Depression
Depressive Disorder
Fatigue
Sleep Deprivation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations

ClinicalTrials.gov processed this record on September 22, 2014