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The Labor and Delivery Teamwork Intervention Trial

NCT ID: NCT00381056

Last Updated: 2006-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2004-03-31

Brief Summary

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A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.

Detailed Description

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A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery. The intervention, called the Labor \& Delivery Team Coordination Course, was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index, AOI). Additional outcomes included 11 clinical process measures.

Conditions

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Adverse Maternal and Neonatal Outcomes

Keywords

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labor and delivery care teamwork training crew resource management cluster-randomized trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Labor and Delivery Team Coordination Course

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* delivery at a participating hospital between 12/31/02-03/31/04
* pregnancy of 20-43 weeks gestation

Exclusion Criteria

* delivery at less than 20 weeks or greater than 43 weeks
Minimum Eligible Age

0 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dynamics Research Corporation

INDUSTRY

Sponsor Role collaborator

Armed Forces Institute of Pathology

FED

Sponsor Role collaborator

TRICARE Management Activity

UNKNOWN

Sponsor Role collaborator

Harvard Risk Management Foundation

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Benjamin P Sachs, MB, BS

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Naval Hospital Campe Pendleton

Oceanside, California, United States

Site Status

Naval Medical Center San Diego

San Diego, California, United States

Site Status

Baptist Health South Florda

Miami, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

National Naval Medical Center Bethesda

Bethesda, Maryland, United States

Site Status

Baystate Hospital

Springfield, Massachusetts, United States

Site Status

South Shore Hospital

Weymouth, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Beaumont Hospital

Royal Oaks, Michigan, United States

Site Status

University of Vermont

Burlington, Vermont, United States

Site Status

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, Greenberg P, McNamee P, Salisbury M, Birnbach DJ, Gluck PA, Pearlman MD, King H, Tornberg DN, Sachs BP. Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):48-55. doi: 10.1097/01.AOG.0000250900.53126.c2.

Reference Type DERIVED
PMID: 17197587 (View on PubMed)

Other Identifiers

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DAMD171-C-0052

Identifier Type: -

Identifier Source: secondary_id

2002-P-000044

Identifier Type: -

Identifier Source: org_study_id