Improving Safety, Patient Experience and Equity Through Shared Decision-making Huddles in Labor

NCT06828406 | Recruiting DMC

• 2 other identifiers: Study00000033BPS-2023C2-33453
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of an existing quality improvement (QI) training program known as TeamBirth, using a randomized stepped-wedge hybrid type II study design, to (a) decrease nulliparous term singleton vertex (NTSV) cesarean birth (CB) across all birthing people, and specifically for Black birthing people, and (b) increase shared decision-making (SDM), (c) improve patient experience of respectful care. TeamBirth uses a train-the-trainer model to implement patient-participatory shared decision-making on Labor and Delivery (L\&D) units, with the goal of decreasing unwanted and unnecessary interventions and improving patient experiences and outcomes for labor and birth.

Conditions

Perinatal Decision Making

Keywords

Shared Decision Making; Quality Improvement; Cesarean Birth; Labor and Delivery; Nulliparous Term Singleton Vertex; Illinois Perinatal Quality Collaborative; Promoting Vaginal Birth; Birth Equity; Severe Maternal Morbidity

Outcome Measures

Primary Outcomes (2)

• Nulliparous Term Singleton Vertex (NTSV) Cesarean Birth (CB)

  NTSV CB Rate for all birthing people in participating hospitals

  6 months prior to TeamBirth, 3 months post TeamBirth implementation

• Shared Decision Making (SDM)

  Childbirth Options, Information, and Person-Centered Explanation (CHOICEs) scale, scores range from 14 to 90, high scores indicate higher levels of shared decision making

  6 months prior to TeamBirth, 3 months post TeamBirth implementation

Secondary Outcomes (7)

• NTSV CB in Black birthing people

  6 months prior to TeamBirth , 3 months post TeamBirth implementation

• SDM in Black birthing people

  6 months prior to TeamBirth, 3 months post TeamBirth implementation

• Patient Experience

  6 months prior to TeamBirth, 3 months post TeamBirth implementation

• Patient Experience

  6 months prior to TeamBirth, 3 months post TeamBirth implementation

• Patient Experience

  6 months prior to TeamBirth, 3 months post TeamBirth implementation

Study Arms (2)

Intervention TeamBirth

OTHER

shared decision making in labor using team huddles

Behavioral: TeamBirth

Usual Care

NO INTERVENTION

Usual Care

Interventions

TeamBirth BEHAVIORAL

TeamBirth

Intervention TeamBirth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• English or Spanish speaking
• Gave birth to a live-born infant after laboring

You may not qualify if:

• Speaks a language other than English or Spanish
• Under the age of 18
• Gave birth to a nonliving infant
• Cesarean delivery without labor

Sponsors & Collaborators

• Endeavor Health: lead
• University of Illinois at Chicago: collaborator
• University of Chicago: collaborator
• Ariadne Labs: collaborator
• University of Michigan: collaborator
• Northwestern University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Endeavor Health Evanston Hospital

Evanston, Illinois, 60201, United States

RECRUITING

Study Officials

• Ann Borders

  Endeavor Health

  PRINCIPAL INVESTIGATOR

• Beth Plunkett

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constandina Kapogiannis

CONTACT

847-570-2832; constandina.kapogiannispolitis@endeavorhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Complete Randomized Stepped Wedge Design

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 14, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 7 years post completion of the final research report. We anticipate the final research report to be completed 7/1/2030.
• Access Criteria: Data collected from this study will be de-identified and banked for further use as required by the funder's Policy for Data Management and Data Sharing policy accessible here: https://www.pcori.org/about/governance/pcoris-policy-data-management-and-data-sharing. According to the funder's policy, the full de-identified, cleaned dataset must be maintained for at least 7 years following completion of the final research report to the funder.

Locations

US (1)