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Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996320
First Posted: October 16, 2009
Last Update Posted: October 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Providence St. Vincent Department of Medicine
Providence Center for Outcomes Research and Education
Information provided by:
Providence Health & Services
  Purpose
The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.

Condition Intervention
Sleep Deprivation Depression Other: Reduced work hour schedule

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors

Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Multiple Sleep Latency Test [ Time Frame: Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle ]

Secondary Outcome Measures:
  • Hours slept per night measured by actigraphy [ Time Frame: Daily ]
  • Pharmaceutical order error rate [ Time Frame: Daily ]
  • Burnout measured by Maslach Burnout Inventory [ Time Frame: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation ]
  • Beck Depression Inventory, Second Edition (BDI-II) [ Time Frame: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation ]
  • Hours worked per shift on the traditional and intervention schedules [ Time Frame: Daily ]

Enrollment: 22
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Schedule
Interns on the intervention schedule work the a modified ICU schedule averaging about 60 hours per week over 4 weeks, with maximum scheduled shift length 16 hours.
Other: Reduced work hour schedule
Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.
No Intervention: Traditional Schedule
Interns on the traditional schedule work the usual ICU schedule averaging about 80 hours per week over 4 weeks, with maximum shift length 30 hours.

Detailed Description:
Each intern enrolled will complete three 4-week rotations in the intensive care unit (ICU) at Providence St. Vincent Medical Center. Each intern will complete at least one traditional schedule and one intervention schedule. The traditional schedule consists of an 80-hour work week with overnight call every third night. The longest shift on the traditional schedule is 30 hours. The intervention schedule consists of a 60-hour work week which eliminates overnight call by assigning a variety of shifts ranging from 8 to 16 hours in length.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Interns rotating at Providence St. Vincent Medical Center ICU

Exclusion Criteria:

  • Diagnosis of narcolepsy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996320


Locations
United States, Oregon
Providence St. Vincent Medical Center Intensive Care Unit
Portland, Oregon, United States, 97225
Sponsors and Collaborators
Providence Health & Services
Providence St. Vincent Department of Medicine
Providence Center for Outcomes Research and Education
Investigators
Principal Investigator: Michelle L Schoepflin Sanders, MD Providence St. Vincent Medical Center
  More Information

Responsible Party: Michelle Schoepflin Sanders MD, Providence St. Vincent Department of Medicine
ClinicalTrials.gov Identifier: NCT00996320     History of Changes
Other Study ID Numbers: IRB 08-74B
First Submitted: August 28, 2009
First Posted: October 16, 2009
Last Update Posted: October 16, 2009
Last Verified: October 2009

Keywords provided by Providence Health & Services:
Internship and Residency
Medical Errors
Burnout, Professional
Burnout
Depression
Actigraphy
Personnel Staffing and Scheduling
Sleep Deprivation
Workload
Humans
Adult
Male
Female
Intensive Care Units
Prospective Studies
Crossover Studies
Work Schedule Tolerance
Disorders of Excessive Somnolence
Guideline Adherence
Internal Medicine Education

Additional relevant MeSH terms:
Depression
Sleep Deprivation
Behavioral Symptoms
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders