Back to resultsWork Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
Primary Purpose
Sleep Deprivation, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduced work hour schedule
Sponsored by
About this trial
This is an interventional prevention trial for Sleep Deprivation focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Interns rotating at Providence St. Vincent Medical Center ICU
Exclusion Criteria:
- Diagnosis of narcolepsy
Sites / Locations
- Providence St. Vincent Medical Center Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Schedule
Traditional Schedule
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Multiple Sleep Latency Test
Secondary Outcome Measures
Hours slept per night measured by actigraphy
Pharmaceutical order error rate
Burnout measured by Maslach Burnout Inventory
Beck Depression Inventory, Second Edition (BDI-II)
Hours worked per shift on the traditional and intervention schedules
Full Information
NCT ID
NCT00996320
First Posted
August 28, 2009
Last Updated
October 15, 2009
Sponsor
Providence Health & Services
Collaborators
Providence St. Vincent Department of Medicine, Providence Center for Outcomes Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT00996320
Brief Title
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
Official Title
Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Providence Health & Services
Collaborators
Providence St. Vincent Department of Medicine, Providence Center for Outcomes Research and Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Depression
Keywords
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Schedule
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Schedule
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reduced work hour schedule
Intervention Description
Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Hours slept per night measured by actigraphy
Time Frame
Daily
Title
Pharmaceutical order error rate
Time Frame
Daily
Title
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
Title
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
Title
Hours worked per shift on the traditional and intervention schedules
Time Frame
Daily
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Interns rotating at Providence St. Vincent Medical Center ICU
Exclusion Criteria:
Diagnosis of narcolepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle L Schoepflin Sanders, MD
Organizational Affiliation
Providence St. Vincent Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence St. Vincent Medical Center Intensive Care Unit
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
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