Perinatal Decision MakingI'M SPEAKINGNCT06828406
Improving Safety, Patient Experience and Equity Through Shared Decision-making Huddles in Labor
A study testing TeamBirth in people with Perinatal Decision Making, run by Endeavor Health at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Decision Making
- What is being tested?
- TeamBirth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 22 sitesUnited States
- Study dates
- 29 Apr 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- English or Spanish speaking
- Gave birth to a live-born infant after laboring
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Endeavor Health Northwest Community Hospital
Arlington Heights, Illinois, 60005
- Recruiting
Rush Copley Medical Center
Aurora, Illinois, 60504
Kaprice Sanchez, 630-499-2309, Kaprice_Sanchez@rush.edu
- Recruiting
Loyola MacNeal Hospital
Berwyn, Illinois, 60402
Elizabeth Marr, 708-783-5721, Elizabeth.Marr@luhs.org
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62901
Mary Jarvis, 618-549-0721 ext. 65252, mary.jarvis@sih.net
- Recruiting
Mount Sinai Hospital
Chicago, Illinois, 60608
Mathura Ananthan, 773-257-4417, Mathura.Ananthan@sinai.org
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Madeline, Doucet, 312-472-1205, Madeline.Kawa@nm.org
- Recruiting
John H Stroger Memorial Hospital
Chicago, Illinois, 60612
Arahany Villasenor, 312-864-6000, arahany.villasenor@cookcountyhhs.org
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Denise Banton, 888-352-7874, Denise_E_Banton@rush.edu
- Recruiting
UI Health
Chicago, Illinois, 60612
Tiana Dunlap, 312-413-4497, tianad@uic.edu
- Recruiting
Saint Mary of Nazareth Hospital
Chicago, Illinois, 60622
Devyani Chawla, 312-770-2147, dchawla2@primehealthcare.com
- Recruiting
Endeavor Health Swedish Hospital
Chicago, Illinois, 60625
- Recruiting
University of Chicago Hospital
Chicago, Illinois, 60637
Caley Schroder, 773-834-2982, Caley.Schroeder@uchicagomedicine.org
- Recruiting
Endeavor Health Elmhurst Hospital
Elmhurst, Illinois, 60126
- Recruiting
Endeavor Health Evanston Hospital
Evanston, Illinois, 60201
- Recruiting
Endeavor Health Highland Park Hospital
Highland Park, Illinois, 60035
- Recruiting
UChicago Medicine AdventHealth Hinsdale
Hinsdale, Illinois, 60521
Rusmea Salah, 630-856-6450, Rusmea.Salah@AdventHealth.com
- Recruiting
Ascension Saint Alexius Medical Center
Hoffman Estates, Illinois, 60169
Britt Solomon, 224-299-6034, britt.solomon@ascension.org
- Recruiting
Riverside Medical Center
Kankakee, Illinois, 60901
Heather Davis, 815-933-1671, hdavis@rhc.net
- Recruiting
Northwestern Medicine Catherine Gratz Griffin Lake Forest Hospital
Lake Forest, Illinois, 60045
Melissa Kelley, 847-535-6326, mkelley@nm.org
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Yara Torres, 708-216-1916, yara.anderson@luhs.org
- Recruiting
Endeavor Health Edward Hospital
Naperville, Illinois, 60540
- Recruiting
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Amy Mehl, 309-683-6754, amy.l.mehl@osfhealthcare.org
About this study
Official title: 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.
- Conditions
- Perinatal Decision Making
- Being tested
- TeamBirth
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeamBirthBehavioural
TeamBirth
| Study group | Role | What they receive |
|---|---|---|
| Intervention TeamBirth | Other | shared decision making in labor using team huddles Receives: Behavioral: TeamBirth |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nulliparous Term Singleton Vertex (NTSV) Cesarean Birth (CB)
NTSV CB Rate for all birthing people in participating hospitals
Measured: 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
Measured: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Secondary outcomes (7)
NTSV CB in Black birthing people
NTSV CB Rate Black birthing people in participating hospitals
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start29 Apr 2025
- Primary completion31 Oct 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Complete Randomized Stepped Wedge Design
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Chicago, University of Chicago, Ariadne Labs, University of Michigan, Northwestern University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Ann Borders, Endeavor Health
- Investigators
- Ann Borders, Principal investigator, Endeavor HealthBeth Plunkett, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828406
- Sponsor's protocol ID
- Study00000033
- Other IDs
- BPS-2023C2-33453
- Acronym
- I'M SPEAKING
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Safety, Patient Experience, and Equity Through Shared Decision-making Huddles in Labor (I'M SPEAKING)
- ClinicalTrials.gov ID
- NCT06828406
- Acronym / sponsor ID
- I'M SPEAKING / Study00000033
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- University of Illinois at Chicago, University of Chicago, Ariadne Labs, University of Michigan, Northwestern University, Patient-Centered Outcomes Research Institute
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Complete Randomized Stepped Wedge Design
| Arm | Type | Receives |
|---|---|---|
| Intervention TeamBirth | Other | Behavioral: TeamBirthshared decision making in labor using team huddles |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- English or Spanish speaking
- Gave birth to a live-born infant after laboring
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeamBirthTeamBirth | Behavioural | Intervention TeamBirth |
Primary outcome
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
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
7 secondary outcomes
NTSV CB in Black birthing people
Time frame: 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
Patient Experience
Time frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience
Time frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience
Time frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience
Time frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Patient Experience
Time frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Borders principal investigator
Endeavor Health
Beth Plunkett principal investigator
Endeavor Health
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeamBirth in people with Perinatal Decision Making, run by Endeavor Health at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Constandina Kapogiannis (847-570-2832, constandina.kapogiannispolitis@endeavorhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nulliparous Term Singleton Vertex (NTSV) Cesarean Birth (CB) (time frame: 6 months prior to TeamBirth, 3 months post TeamBirth implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.