Work Hour Reductions, Medical Errors, and Intern Well-Bei... | NCT00996320

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

NCT00996320

Sponsor

Providence Health & Services

Status

Completed

Last Update Posted

Oct 16, 2009Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Sleep Deprivation
Depression

Interventions

Reduced work hour schedule

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Aug 28, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2009

Last Update Posted Date

Oct 16, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Providence Health & ServicesOTHER

Collaborators

Name	Class
Providence St. Vincent Department of Medicine	UNKNOWN
Providence Center for Outcomes Research and Education	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Reduced work hour schedule	Other	Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.	Intervention Schedule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Hours slept per night measured by actigraphy		Daily
Pharmaceutical order error rate		Daily
Burnout measured by Maslach Burnout Inventory

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Interns rotating at Providence St. Vincent Medical Center ICU

Exclusion Criteria:

Diagnosis of narcolepsy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michelle L Schoepflin Sanders, MD	Providence St. Vincent Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Providence St. Vincent Medical Center Intensive Care Unit		Portland	Oregon	97225	United States

Condition Browse Module

MeSH Terms

ID	Term
D012892	Sleep Deprivation
D003863	Depression
D002055	Burnout, Professional
D000077062	Burnout, Psychological
D006970	Disorders of Excessive Somnolence

Ancestor Terms

ID	Term
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided