Clinical trial NCT06828406: Improving Safety, Patient Experience and Equity Through Shared Decision-making Huddles in Labor
Official title: Improving Safety, Patient Experience, and Equity Through Shared Decision-making Huddles in Labor (I'M SPEAKING)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: University of Chicago
name: Ariadne Labs
name: University of Michigan
name: Northwestern University
First posted: 2025-02-14
Enrollment: 2200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Complete Randomized Stepped Wedge Design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nulliparous Term Singleton Vertex (NTSV) Cesarean Birth (CB)
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
measure: Shared Decision Making (SDM)
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Secondary outcomes:
measure: NTSV CB in Black birthing people
timeFrame: 6 months prior to TeamBirth , 3 months post TeamBirth implementation
measure: SDM in Black birthing people
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
measure: Patient Experience
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
measure: Patient Experience
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
measure: Patient Experience
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
measure: Patient Experience
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
measure: Patient Experience
timeFrame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Other outcomes:
Locations:
Study officials:
affiliation: Endeavor Health
name: Ann Borders
role: PRINCIPAL_INVESTIGATOR
affiliation: Endeavor Health
name: Beth Plunkett
role: PRINCIPAL_INVESTIGATOR
References: