Health TrialsbyHealthPanel

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

ConditionPregnancy Related
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BUNDLE

    Other intervention

    An integrated model of community-based doulas and clinical obstetric providers

  • Usual Care

    Other intervention

    Standard of care for pregnancy and pregnancy-related issues by the obstetric provider

Treatment groups

412 Participants
are divided into 2 treatment groups
Group A: BUNDLE InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From study enrollment and until 12 months postpartum

Secondary outcomes

1

Trust in Provider

A validated 11-item instrument used to measure patients' trust in the provider regarding dependability, confidence, and confidentiality of information.

Time frame
Baseline; third trimester, and postpartum
2

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.

Time frame
Baseline, third trimester and postpartum
3

Perceived Stress

Measured with Cohen's Perceived Stress Scale

Time frame
Baseline, third trimester and postpartum
4

Depression

Measured with the Patient Health Questionnaire-9 (PHQ-9)

Time frame
Baseline, third trimester and postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
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