Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 412
- Locations
- 1
- Primary Endpoint
- Perinatal Healthcare Engagement
Study Overview
Brief Summary
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black/African American (AA) birthing people and with medical and community healthcare providers to elicit feedback on how best to integrate community-based doulas and obstetricians into one united model of prenatal care to promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the newly developed model on healthcare engagement, trust, and adverse maternal outcomes using randomized control trial of 412 Black/AA pregnant participants. Phase 3 is dissemination of BUNDLE findings in scholarly and community-based forums, including with healthcare leaders and policy makers in Wisconsin, advocating for doula coverage and health system sustainability of the integrated model.
Detailed Description
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The investigators will pursue the following aims using a multidisciplinary team of experts in health disparities, community engagement, qualitative research, maternal-fetal medicine, and doula support:
Aim 1: Develop an integrated prenatal care model of medical providers and community doulas in Southeastern Wisconsin Approach: The investigators will conduct six focus groups with 30 Black/AA birthing people (currently pregnant or recently postpartum) and 30 prenatal healthcare providers (obstetricians, midwives, doulas, social workers, prenatal care coordinators, nurses, mental health providers, and obstetric unit leaders) to elicit feedback on models of doula/medical provider integration with the overarching aim of building trust and improving maternal health outcomes. Focus group findings will be reviewed with a community advisory panel (CAP) developed as part of the Community Partnership of the MCW U54 center, to gain the CAP's input on intervention development.
Aim 2: Compare the effectiveness of the integrated prenatal care model to standard prenatal care in improving healthcare engagement and trust and reducing adverse maternal outcomes Approach: In a two-arm randomized controlled trial conducted at Froedtert and MCW, the investigators will randomize 412 Black/AA pregnant people to BUNDLE or standard prenatal care. Primary outcome is healthcare engagement (starting prenatal care in 1st trimester, attending at least 70% of the recommended visits, attending the postpartum visit, and receipt of recommended vaccination during pregnancy). Secondary outcomes include medical mistrust measured by trust in provider scale, perceived discrimination, and frequencies of severe maternal morbidity as defined by the Centers for Disease Control.
Aim 3: Disseminate findings to scholarly and community-based forums and actively pursue opportunities for systems- and policy-level change Approach: The investigators will disseminate findings regularly in scholarly (conference, grand rounds) and community-based (listening session, town hall) forums. The investigators will leverage the existing partnerships with policymakers, healthcare organizations, and community leaders to implement strategies to sustain successful program outcomes through policy changes at the system and statewide level by advocating for doula coverage and healthcare system sustainability of the integrated prenatal care model.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Self-reported Black or African American
- •Pregnant with singleton gestation
- •Has an established OBGY at Froedtert & the Medical College of Wisconsin (F&MCW) Health System
Exclusion Criteria
- •Planning to deliver outside of F&MCW Health System
- •Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula
- •Inability or unwillingness to provide informed consent
Arms & Interventions
BUNDLE Intervention
Proposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction.
Intervention: BUNDLE (Other)
Usual Care
Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Perinatal Healthcare Engagement
Time Frame: From study enrollment and until 12 months postpartum
A composite of the following variables to assess perinatal healthcare engagement: 1) Attended at least \~75% of the recommended prenatal visits; 2) Attended postpartum visit; 3) Received recommended vaccination during pregnancy.
Secondary Outcomes
- Perceived Stress(Baseline, third trimester and postpartum)
- Cesarean birth(At study completion)
- Reported Discrimination(Baseline, third trimester and postpartum)
- Depression(Baseline, third trimester and postpartum)
- Unplanned healthcare utilization(Up to 12 months postpartum)
- Group-Based Medical Mistrust Scale(Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum))
- Trust in Provider(Baseline; third trimester, and postpartum)
- Breastfeeding Initiation(Up to 12 months postpartum)
- Severe Maternal Morbidity(Up to 12 months postpartum)
Investigators
Anna Palatnik, MD
Associate Professor
Medical College of Wisconsin