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

Study acronym: I'M SPEAKING
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites expanded: 1 → 22 locations
    • Eligibility criteria expanded, about 20 words
    v4
  2. Collaborators: 5 to 6v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2025 to Apr 29, 2025
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06828406
Lead Sponsor Endeavor Health
Collaborators: University of Illinois at Chicago, University of Chicago, Ariadne Labs, University of Michigan, Northwestern University, Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)		 Perinatal Decision Making
Enrollment 2,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov