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NCT Number: NCT06828406

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Endeavor Health Northwest Community Hospital, Arlington Heights, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TeamBirth

Behavioral

TeamBirth

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Constandina Kapogiannis

CONTACT

[email protected]

847-570-2832

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Ariadne Labs
  • Northwestern University
  • Patient-Centered Outcomes Research Institute
  • University of Chicago
  • University of Illinois at Chicago
  • University of Michigan

Registry information

Official study title

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

Acronym: I'M SPEAKING

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 14, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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