- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03529214
An Evaluation of the Team Birth Project
A Program Evaluation to Measure the Feasibility of the Team Birth Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States. TeamBirth is a rigorously designed care process to improve care and SDM across the full care team, which includes the patient, their support person(s), nurse and physician or midwife, by ensuring reliability for best practices in communication and teamwork during labor and delivery. TeamBirth aims to operationalize best practices in communication and clinical care from the major professional organizations in obstetrics, including the American College of Obstetricians & Gynecologists (ACOG), Society for Maternal-Fetal Medicine (SMFM), American College of Nurse-Midwives (ACNM), and Association of Women's Health, Obstetric, and Neonatal Nurses (AWHONN), to ensure these practices are occurring consistently throughout labor. Key TeamBirth practices include:
- Promoting the roles of the laboring patient, nurse, and delivering provider as members of the care team with equally valuable input for SDM,
- Eliciting the patient's preferences, symptoms, and subjective experiences and integrating them with clinical data to inform patient care plans,
- Distinguishing statuses and care plans for the mother, fetus, and labor progress, and
- Setting shared expectations for the next planned evaluation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Weymouth, Massachusetts, United States, 02190
- South Shore Hospital
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Saint Francis Hospital
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Washington
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Bellevue, Washington, United States, 98004
- Overlake Medical Center
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Kirkland, Washington, United States, 98034
- EvergreenHealth Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Clinician Participant Inclusion Criteria:
- All clinicians who have practice privileges at a study site
Clinician Participant Exclusion Criteria:
- None
Implementation Team Participant Inclusion Criteria:
- Champions, super-users and others who have been involved in the implementation of "Team Birth Project" at a study site
Implementation Team Participant Exclusion Criteria:
- None
Patient Participant Inclusion Criteria:
- 18 years or older
- Live birth. Includes: spontaneous or induction of labor; Vaginally, with an instruments (forceps / vacuum), or unscheduled cesarean delivery
- Patient at a study site piloting "Team Birth Project"
Patient Participant Exclusion Criteria:
- Under 18 years old
- Scheduled cesarean delivery
- Experienced intrapartum, stillbirth, or neonatal death
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Implemented Health Facility
Health facility that has piloted the "Team Birth Project"
|
The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients).
The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback.
A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of Clinicians Recommending TeamBirth Project
Time Frame: The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). If clinicians complete more than one survey in the window, we will use the first one.
|
At the project midline, percent of clinicians (physicians, midwives, and nurses) who would definitely or probably recommend the Team Birth project tools for use in other labor and delivery units.
|
The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). If clinicians complete more than one survey in the window, we will use the first one.
|
|
Percent of Patients With the Role They Wanted in Decision-Making
Time Frame: The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). Patients were only offered the survey once within the window.
|
At the project midline, percent of patients who definitely or somewhat had the role they wanted in making decisions about their labor, among patients who wanted to make collaborative decisions with clinicians.
|
The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). Patients were only offered the survey once within the window.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amber Weiseth, DNP, RN, Harvard School of Public Health (HSPH)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB18-0550
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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