Clinical trial NCT00381056: The Labor and Delivery Teamwork Intervention Trial
Official title: The Labor and Delivery Teamwork Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Maternal and Neonatal Outcomes
Keywords: labor and delivery care
teamwork training
crew resource management
cluster-randomized trial
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Dynamics Research Corporation
name: Armed Forces Institute of Pathology
name: TRICARE Management Activity
name: Harvard Risk Management Foundation
First posted: 2006-09-27
Enrollment: 30000
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: 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: 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 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

Primary outcomes:
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 outcomes:
measure: Additional outcomes were eleven process measures that recorded length of care or delay to action.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Oceanside
country: United States
facility: Naval Hospital Campe Pendleton
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Miami
country: United States
facility: Baptist Health South Florda
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Bethesda
country: United States
facility: National Naval Medical Center Bethesda
state: Maryland
city: Springfield
country: United States
facility: Baystate Hospital
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oaks
country: United States
facility: Beaumont Hospital
state: Michigan
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Benjamin P Sachs, MB, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.