The Labor and Delivery Teamwork Intervention Trial

September 26, 2006 updated by: Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

30000

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University Of Alabama
    • California
      • Oceanside, California, United States
        • Naval Hospital Campe Pendleton
      • San Diego, California, United States
        • Naval Medical Center San Diego
    • Florida
      • Miami, Florida, United States
        • University of Miami
      • Miami, Florida, United States
        • Baptist Health South Florda
    • Hawaii
      • Honolulu, Hawaii, United States
        • Tripler Army Medical Center
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Hospital
      • Bethesda, Maryland, United States
        • National Naval Medical Center Bethesda
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Baystate Hospital
      • Weymouth, Massachusetts, United States
        • South Shore Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
      • Royal Oaks, Michigan, United States
        • Beaumont Hospital
    • Vermont
      • Burlington, Vermont, United States
        • University of Vermont
    • Virginia
      • Portsmouth, Virginia, United States
        • Naval Medical Center Portsmouth
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

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

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).

Secondary Outcome Measures

Outcome Measure
Additional outcomes were eleven process measures that recorded length of care or delay to action.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Harvard Risk Management Foundation
Dynamics Research Corporation
Armed Forces Institute of Pathology
TRICARE Management Activity

Investigators

  • Principal Investigator: Benjamin P Sachs, MB, BS, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2000

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 27, 2006

Last Update Submitted That Met QC Criteria

September 26, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2002-P-000044
  • DAMD171-C-0052

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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