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

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
      • 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.

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

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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