An Evaluation of the Team Birth Project

Cesarean Section Complications Clinical Trial

Official title:

A Program Evaluation to Measure the Feasibility of the Team Birth Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529214
• Other study ID #: IRB18-0550
• Status: Completed
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5217
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Communication, Multidisciplinary
• Maternal Complication of Pregnancy
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
United States	Overlake Medical Center	Bellevue	Washington
United States	EvergreenHealth Medical Center	Kirkland	Washington
United States	Saint Francis Hospital	Tulsa	Oklahoma
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days).