Improving Safety, Patient Experience and Equity Through Shared Decision-making Huddles in Labor (I'M SPEAKING)

Improving Safety, Patient Experience, and Equity Through Shared Decision-making Huddles in Labor (I'M SPEAKING)

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.

Study Overview

• Status: Recruiting
• Conditions: Perinatal Decision Making
• Intervention / Treatment: Behavioral: TeamBirth

• Study Type: Interventional
• Enrollment (Estimated): 2200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Constandina Kapogiannis; Phone Number: 847-570-2832; Email: constandina.kapogiannispolitis@endeavorhealth.org

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • Endeavor Health Evanston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Other: Intervention TeamBirth; shared decision making in labor using team huddles	Behavioral: TeamBirth; TeamBirth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NTSV CB in Black birthing people	NTSV CB Rate Black birthing people in participating hospitals	6 months prior to TeamBirth , 3 months post TeamBirth implementation
SDM in Black birthing people	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
Patient Experience	Illinois Perinatal Quality Collaborative (ILPQC) Patient-Reported Experience Measure (PREM), there is no numerical value assigned to the ILPQC PREM	6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience	Mother's Autonomy in Decision Making (MADM), scores range from 7 to 42, higher scores indicate the women had greater agency and autonomy when engaging in a shared decision making process with a maternity care provider	6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience	Person-Centered Maternity Care Scale for use in the United States (PCMC-US), scores range from 0 to 100, higher scores indicate more person-centered maternity care	6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience	CollaboRATE, scores range from 0 to 100, a higher score means the number of core dimensions of shared decision making are met	6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience	Acceptability of Intervention Measure (AIM), scores range from 3 to 15, the lower the score, the more satisfied the patient was with their care	6 months prior to TeamBirth, 3 months post TeamBirth implementation

Collaborators and Investigators

• Sponsor: Endeavor Health
• Collaborators: Patient-Centered Outcomes Research Institute; Northwestern University; University of Chicago; University of Michigan; University of Illinois at Chicago; Ariadne Labs
• Investigators: Principal Investigator: Ann Borders, Endeavor Health; Principal Investigator: Beth Plunkett, Endeavor Health

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Shared Decision Making; Labor and Delivery; Quality Improvement; Cesarean Birth; Nulliparous Term Singleton Vertex; Illinois Perinatal Quality Collaborative; Promoting Vaginal Birth; Birth Equity; Severe Maternal Morbidity
• Other Study ID Numbers: Study00000033; BPS-2023C2-33453 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data to be banked may include:

• De-identified transcripts of clinician, birthing person, partner/support person focus groups or interviews
• De-identified ethnographic field notes
• De-identified birthing person, partner/support person survey data
• De-identified administrative data on birth outcomes for Illinois hospitals

• IPD Sharing Time Frame: 7 years post completion of the final research report. We anticipate the final research report to be completed 7/1/2030.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No