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Recruiting NCT06828406

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

No phase Interventional Perinatal Decision Making

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TeamBirth.
Who it may be relevant to
Registry conditions: Perinatal Decision Making. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral TeamBirth
    TeamBirth

Primary outcome measures

  • Nulliparous Term Singleton Vertex (NTSV) Cesarean Birth (CB) [Time frame: 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]
Secondary outcome measures (7)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 22 centers
  • Endeavor Health Northwest Community Hospital — Arlington Heights
  • Rush Copley Medical Center — Aurora
  • Loyola MacNeal Hospital — Berwyn
  • Memorial Hospital of Carbondale — Carbondale
  • Mount Sinai Hospital — Chicago
  • Northwestern Memorial Hospital — Chicago
  • John H Stroger Memorial Hospital — Chicago
  • Rush University Medical Center — Chicago
  • … and 14 more centers

Identifiers

NCT: NCT06828406 · Study00000033 · BPS-2023C2-33453

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗