Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE (BUNDLE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: BUNDLE; Other: Usual Care

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 Type: Interventional
• Enrollment (Estimated): 412
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Palatnik, MD; Phone Number: (414) 805-6624; Email: apalatnik@mcw.edu
• Study Contact Backup: Name: Joni S Williams, MD, MPH; Phone Number: (414) 955-8827; Email: jswilliams@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: BUNDLE; An integrated model of community-based doulas and clinical obstetric providers
Active Comparator: Usual Care; Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.	Other: Usual Care; Standard of care for pregnancy and pregnancy-related issues by the obstetric provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Perceived Stress	Measured with Cohen's Perceived Stress Scale	Baseline, third trimester and postpartum
Depression	Measured with the Patient Health Questionnaire-9 (PHQ-9)	Baseline, third trimester and postpartum
Cesarean birth	Cesarean birth for any indication other than prior cesarean	At study completion
Unplanned healthcare utilization	Prenatal or postpartum (up to 12 weeks postpartum) unplanned emergency room visits or hospitalizations.	Up to 12 months postpartum
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
Breastfeeding Initiation	Rates of breastfeeding initiation prior to discharge from the hospital	Up to 12 months postpartum
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)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PRO00047801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No