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

July 13, 2026 updated by: Ann Borders, Endeavor Health

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Recruiting
        • Endeavor Health Northwest Community Hospital
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush Copley Medical Center
        • Contact:
      • Berwyn, Illinois, United States, 60402
        • Recruiting
        • Loyola MacNeal Hospital
        • Contact:
      • Carbondale, Illinois, United States, 62901
        • Recruiting
        • Memorial Hospital of Carbondale
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
      • Chicago, Illinois, United States, 60608
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • UI Health
        • Contact:
      • Chicago, Illinois, United States, 60625
        • Recruiting
        • Endeavor Health Swedish Hospital
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60622
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Endeavor Health Elmhurst Hospital
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health Evanston Hospital
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • Endeavor Health Highland Park Hospital
      • Hinsdale, Illinois, United States, 60521
      • Hoffman Estates, Illinois, United States, 60169
        • Recruiting
        • Ascension Saint Alexius Medical Center
        • Contact:
      • Kankakee, Illinois, United States, 60901
        • Recruiting
        • Riverside Medical Center
        • Contact:
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Catherine Gratz Griffin Lake Forest Hospital
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Endeavor Health Edward Hospital
      • Peoria, Illinois, United States, 61637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nulliparous Term Singleton Vertex (NTSV) Cesarean Birth (CB)
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
NTSV CB Rate for all birthing people in participating hospitals
6 months prior to TeamBirth, 3 months post TeamBirth implementation
Shared Decision Making (SDM)
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NTSV CB in Black birthing people
Time Frame: 6 months prior to TeamBirth , 3 months post TeamBirth implementation
NTSV CB Rate Black birthing people in participating hospitals
6 months prior to TeamBirth , 3 months post TeamBirth implementation
SDM in Black birthing people
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
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
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
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
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
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
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
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
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
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
Time Frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endeavor Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Northwestern University
University of Chicago
University of Michigan
University of Illinois at Chicago
Ariadne Labs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann Borders, Endeavor Health
  • Principal Investigator: Beth Plunkett, Endeavor Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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