- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00996320
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
October 15, 2009 updated by: Providence Health & Services
Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97225
- Providence St. Vincent Medical Center Intensive Care Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Interns rotating at Providence St. Vincent Medical Center ICU
Exclusion Criteria:
- Diagnosis of narcolepsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hours slept per night measured by actigraphy
Time Frame: Daily
|
Daily
|
Pharmaceutical order error rate
Time Frame: Daily
|
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
|
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
|
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
|
Daily
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle L Schoepflin Sanders, MD, Providence St. Vincent Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
August 28, 2009
First Submitted That Met QC Criteria
October 15, 2009
First Posted (Estimate)
October 16, 2009
Study Record Updates
Last Update Posted (Estimate)
October 16, 2009
Last Update Submitted That Met QC Criteria
October 15, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
- Depression
- Humans
- Prospective Studies
- Adult
- Female
- Male
- Burnout
- Intensive Care Units
- Sleep Deprivation
- Actigraphy
- Internship and Residency
- Medical Errors
- Burnout, Professional
- Personnel Staffing and Scheduling
- Workload
- Work Schedule Tolerance
- Disorders of Excessive Somnolence
- Guideline Adherence
- Internal Medicine Education
- Crossover Studies
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 08-74B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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