An Evaluation of the Team Birth Project

Sponsor
Harvard School of Public Health (HSPH) (Other)
Overall Status
Completed
CT.gov ID
NCT03529214
Collaborator
Brigham and Women's Hospital (Other)
5,217
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1
19.1
1304.3
68.3

Study Details

Study Description

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
  • Behavioral: Exposed study site
N/A

Study Design

Study Type:
Interventional
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 :
Sep 30, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability to clinicians [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 South Shore Hospital Weymouth Massachusetts United States 02190
2 Saint Francis Hospital Tulsa Oklahoma United States 74136
3 Overlake Medical Center Bellevue Washington United States 98004
4 EvergreenHealth Medical Center Kirkland Washington United States 98034

Sponsors and Collaborators

  • Harvard School of Public Health (HSPH)
  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Neel T Shah, MD, MPP, Harvard School of Public Health (HSPH)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neel Shah, Principal Investigator, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier:
NCT03529214
Other Study ID Numbers:
  • IRB18-0550
First Posted:
May 18, 2018
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Neel Shah, Principal Investigator, Harvard School of Public Health (HSPH)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2020