Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Pregnancy Related Clinical Trial

— BUNDLE  

Official title:

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05993689
• Other study ID #: PRO00047801
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: June 30, 2030

Study information

• Verified date: May 2024
• Source: Medical College of Wisconsin
• Contact: Anna Palatnik, MD
• Phone: (414) 805-6624
• Email: apalatnik[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 412
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• BUNDLE
An integrated model of community-based doulas and clinical obstetric providers
• Usual Care
Standard of care for pregnancy and pregnancy-related issues by the obstetric provider

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal Healthcare Engagement	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.	From study enrollment and until 12 months postpartum
Secondary	Trust in Provider	A validated 11-item instrument used to measure patients' trust in the provider regarding dependability, confidence, and confidentiality of information.	Baseline; third trimester, and postpartum
Secondary	Reported Discrimination	Measured with a validated survey of patient self-report on how often in the past 12 months, individuals felt treated poorly due to race.	Baseline, third trimester and postpartum
Secondary	Perceived Stress	Measured with Cohen's Perceived Stress Scale	Baseline, third trimester and postpartum
Secondary	Depression	Measured with the Patient Health Questionnaire-9 (PHQ-9)	Baseline, third trimester and postpartum
Secondary	Cesarean birth	Cesarean birth for any indication other than prior cesarean	At study completion
Secondary	Unplanned healthcare utilization	Prenatal or postpartum (up to 12 weeks postpartum) unplanned emergency room visits or hospitalizations.	Up to 12 months postpartum
Secondary	Severe Maternal Morbidity	Composite outcome of the following diagnoses using ICD-10 codes: acute myocardial infarction, aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, disseminated intravascular coagulation, eclampsia, heart failure, puerperal cerebrovascular disorders, pulmonary edema, severe anesthesia complications, sepsis, shock, sickle cell disease with crisis, air and thrombotic embolism blood products transfusion, hysterectomy, temporary tracheostomy, ventilation.	Up to 12 months postpartum
Secondary	Breastfeeding Initiation	Rates of breastfeeding initiation prior to discharge from the hospital	Up to 12 months postpartum
Secondary	Group-Based Medical Mistrust Scale	A 12-item validated survey focused on healthcare provided in the social context of racism and discrimination.	Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum)