The Labor and Delivery Teamwork Intervention Trial
This study has been completed.
Sponsor:
Beth Israel Deaconess Medical Center
Collaborators:
Dynamics Research Corporation
Armed Forces Institute of Pathology
TRICARE Management Activity
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
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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 |
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
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
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 May 21, 2013