The Labor and Delivery Teamwork Intervention Trial

This study has been completed.
Sponsor:
Collaborators:
Dynamics Research Corporation
Armed Forces Institute of Pathology
TRICARE Management Activity
Harvard Risk Management Foundation
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00381056
First received: September 26, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Adverse Maternal and Neonatal Outcomes
Behavioral: Labor and Delivery Team Coordination Course

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: The Labor and Delivery Teamwork Intervention Trial

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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:
  • Additional outcomes were eleven process measures that recorded length of care or delay to action.

Estimated Enrollment: 30000
Study Start Date: July 2000
Estimated Study Completion Date: March 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381056

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States
United States, California
Naval Hospital Campe Pendleton
Oceanside, California, United States
Naval Medical Center San Diego
San Diego, California, United States
United States, Florida
University of Miami
Miami, Florida, United States
Baptist Health South Florda
Miami, Florida, United States
United States, Hawaii
Tripler Army Medical Center
Honolulu, Hawaii, United States
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States
National Naval Medical Center Bethesda
Bethesda, Maryland, United States
United States, Massachusetts
Baystate Hospital
Springfield, Massachusetts, United States
South Shore Hospital
Weymouth, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
Beaumont Hospital
Royal Oaks, Michigan, United States
United States, Vermont
University of Vermont
Burlington, Vermont, United States
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dynamics Research Corporation
Armed Forces Institute of Pathology
TRICARE Management Activity
Harvard Risk Management Foundation
Investigators
Principal Investigator: Benjamin P Sachs, MB, BS Beth Israel Deaconess Medical Center
  More Information

No publications provided by Beth Israel Deaconess Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00381056     History of Changes
Other Study ID Numbers: 2002-P-000044, DAMD171-C-0052
Study First Received: September 26, 2006
Last Updated: September 26, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
labor and delivery care
teamwork training
crew resource management
cluster-randomized trial

ClinicalTrials.gov processed this record on August 21, 2014