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An Evaluation of the Team Birth Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529214
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Neel Shah, Harvard School of Public Health

Brief Summary:
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States

Condition or disease Intervention/treatment Phase
Pregnancy Complications Cesarean Section Complications Maternal Complication of Pregnancy Communication, Multidisciplinary Behavioral: Exposed study site Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5217 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Program Evaluation to Measure the Feasibility of the Team Birth Project
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Implemented Health Facility
Health facility that has piloted the "Team Birth Project"
Behavioral: Exposed study site
The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys.




Primary Outcome Measures :
  1. Acceptability to clinicians [ Time Frame: The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). If clinicians complete more than one survey in the window, we will use the first one. ]
    At the project midline, percent of clinicians (physicians, midwives, and nurses) who would definitely or probably recommend the Team Birth project tools for use in other labor and delivery units.

  2. Acceptability to patients [ Time Frame: The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). ]
    At the project midline, percent of patients who definitely or somewhat had the role they wanted in making decisions about their labor, among patients who wanted to make collaborative decisions with clinicians.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Clinician Participant Inclusion Criteria:

  • All clinicians who have practice privileges at a study site

Clinician Participant Exclusion Criteria:

  • None

Implementation Team Participant Inclusion Criteria:

  • Champions, super-users and others who have been involved in the implementation of "Team Birth Project" at a study site

Implementation Team Participant Exclusion Criteria:

  • None

Patient Participant Inclusion Criteria:

  • 18 years or older
  • Live birth. Includes: spontaneous or induction of labor; Vaginally, with an instruments (forceps / vacuum), or unscheduled cesarean delivery
  • Patient at a study site piloting "Team Birth Project"

Patient Participant Exclusion Criteria:

  • Under 18 years old
  • Scheduled cesarean delivery
  • Experienced intrapartum, stillbirth, or neonatal death

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529214


Locations
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United States, Massachusetts
South Shore Hospital
Weymouth, Massachusetts, United States, 02190
United States, Oklahoma
Saint Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Washington
Overlake Medical Center
Bellevue, Washington, United States, 98004
EvergreenHealth Medical Center
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Harvard School of Public Health
Brigham and Women's Hospital
Investigators
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Principal Investigator: Neel T Shah, MD, MPP Harvard School of Public Health
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Responsible Party: Neel Shah, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03529214    
Other Study ID Numbers: IRB18-0550
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neel Shah, Harvard School of Public Health:
Quality Improvement
Program Evaluation
Quality Assurance
Feasibility
Acceptability
Additional relevant MeSH terms:
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Pregnancy Complications