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An Evaluation of the Team Birth Project

Primary Purpose

Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposed study site
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Complications focused on measuring Quality Improvement, Program Evaluation, Quality Assurance, Feasibility, Acceptability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Shore Hospital
  • Saint Francis Hospital
  • Overlake Medical Center
  • EvergreenHealth Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Implemented Health Facility

Arm Description

Health facility that has piloted the "Team Birth Project"

Outcomes

Primary Outcome Measures

Acceptability to clinicians
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.
Acceptability to patients
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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2018
Last Updated
March 18, 2020
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03529214
Brief Title
An Evaluation of the Team Birth Project
Official Title
A Program Evaluation to Measure the Feasibility of the Team Birth Project
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy, Communication, Multidisciplinary
Keywords
Quality Improvement, Program Evaluation, Quality Assurance, Feasibility, Acceptability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implemented Health Facility
Arm Type
Other
Arm Description
Health facility that has piloted the "Team Birth Project"
Intervention Type
Behavioral
Intervention Name(s)
Exposed study site
Intervention Description
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 Measure Information:
Title
Acceptability to clinicians
Description
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.
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.
Title
Acceptability to patients
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neel T Shah, MD, MPP
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Shore Hospital
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Saint Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Overlake Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
EvergreenHealth Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Evaluation of the Team Birth Project

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