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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06828406
Acronym
I'M SPEAKING
Enrollment
2200
Registered
2025-02-14
Start date
2025-04-29
Completion date
2029-07-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALTeamBirth

TeamBirth

Sponsors

Endeavor Health
Lead SponsorOTHER
University of Illinois at Chicago
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Ariadne Labs
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Complete Randomized Stepped Wedge Design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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 * Individuals who have already completed the ILPQC PREM or ILPQC PREM+ survey during the current hospital admission will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Nulliparous Term Singleton Vertex (NTSV) Cesarean Birth (CB)6 months prior to TeamBirth, 3 months post TeamBirth implementationNTSV CB Rate for all birthing people in participating hospitals
Shared Decision Making (SDM)6 months prior to TeamBirth, 3 months post TeamBirth implementationChildbirth Options, Information, and Person-Centered Explanation (CHOICEs) scale, scores range from 14 to 90, high scores indicate higher levels of shared decision making

Secondary

MeasureTime frameDescription
NTSV CB in Black birthing people6 months prior to TeamBirth , 3 months post TeamBirth implementationNTSV CB Rate Black birthing people in participating hospitals
SDM in Black birthing people6 months prior to TeamBirth, 3 months post TeamBirth implementationChildbirth Options, Information, and Person-Centered Explanation (CHOICEs) scale, scores range from 14 to 90, high scores indicate higher levels of shared decision making
Patient Experience6 months prior to TeamBirth, 3 months post TeamBirth implementationIllinois Perinatal Quality Collaborative (ILPQC) Patient-Reported Experience Measure (PREM), there is no numerical value assigned to the ILPQC PREM

Countries

United States

Contacts

CONTACTConstandina Kapogiannis
constandina.kapogiannispolitis@endeavorhealth.org847-570-2832
PRINCIPAL_INVESTIGATORAnn Borders

Endeavor Health

PRINCIPAL_INVESTIGATORBeth Plunkett

Endeavor Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026