NCT00996320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

August 28, 2009

Last Update Submit

October 15, 2009

Conditions

Keywords

Internship and ResidencyMedical ErrorsBurnout, ProfessionalBurnoutDepressionActigraphyPersonnel Staffing and SchedulingSleep DeprivationWorkloadHumansAdultMaleFemaleIntensive Care UnitsProspective StudiesCrossover StudiesWork Schedule ToleranceDisorders of Excessive SomnolenceGuideline AdherenceInternal Medicine Education

Outcome Measures

Primary Outcomes (1)

  • Multiple Sleep Latency Test

    Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle

Secondary Outcomes (5)

  • Hours slept per night measured by actigraphy

    Daily

  • Pharmaceutical order error rate

    Daily

  • Burnout measured by Maslach Burnout Inventory

    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)

    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

    Daily

Study Arms (2)

Intervention Schedule

EXPERIMENTAL

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

Traditional Schedule

NO INTERVENTION

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.

Interventions

Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.

Intervention Schedule

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Interns rotating at Providence St. Vincent Medical Center ICU

You may not qualify if:

  • Diagnosis of narcolepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence St. Vincent Medical Center Intensive Care Unit

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Sleep DeprivationDepressionBurnout, ProfessionalBurnout, PsychologicalDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehaviorOccupational StressOccupational DiseasesStress, PsychologicalSleep Disorders, Intrinsic

Study Officials

  • Michelle L Schoepflin Sanders, MD

    Providence St. Vincent Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2009

First Posted

October 16, 2009

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations