Clinical trial NCT05993689: Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
Official title: Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 412
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perinatal Healthcare Engagement
timeFrame: From study enrollment and until 12 months postpartum
Secondary outcomes:
measure: Trust in Provider
timeFrame: Baseline; third trimester, and postpartum
measure: Reported Discrimination
timeFrame: Baseline, third trimester and postpartum
measure: Perceived Stress
timeFrame: Baseline, third trimester and postpartum
measure: Depression
timeFrame: Baseline, third trimester and postpartum
measure: Cesarean birth
timeFrame: At study completion
measure: Unplanned healthcare utilization
timeFrame: Up to 12 months postpartum
measure: Severe Maternal Morbidity
timeFrame: Up to 12 months postpartum
measure: Breastfeeding Initiation
timeFrame: Up to 12 months postpartum
measure: Group-Based Medical Mistrust Scale
timeFrame: Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: