NCT03529214

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

May 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2025

Completed
Last Updated

May 14, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 16, 2018

Results QC Date

September 30, 2020

Last Update Submit

April 26, 2025

Conditions

Keywords

Quality ImprovementProgram EvaluationQuality AssuranceFeasibilityAcceptability

Outcome Measures

Primary Outcomes (2)

  • Percent of Clinicians Recommending TeamBirth Project

    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.

  • Percent of Patients With the Role They Wanted in Decision-Making

    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). Patients were only offered the survey once within the window.

Study Arms (1)

Implemented Health Facility

OTHER

Health facility that has piloted the "Team Birth Project"

Behavioral: Exposed study site

Interventions

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.

Implemented Health Facility

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All clinicians who have practice privileges at a study site

You may not qualify if:

  • None
  • Champions, super-users and others who have been involved in the implementation of "Team Birth Project" at a study site
  • None
  • 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"
  • Under 18 years old
  • Scheduled cesarean delivery
  • Experienced intrapartum, stillbirth, or neonatal death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Saint Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Overlake Medical Center

Bellevue, Washington, 98004, United States

Location

EvergreenHealth Medical Center

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Pregnancy ComplicationsCommunication

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavior

Results Point of Contact

Title
Dr. Amber Weiseth
Organization
Ariadne Labs

Study Officials

  • Amber Weiseth, DNP, RN

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 18, 2018

Study Start

May 29, 2018

Primary Completion

September 30, 2019

Study Completion

December 31, 2019

Last Updated

May 14, 2025

Results First Posted

May 14, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations