跳至主要内容
临床试验/NCT05993689
NCT05993689招募中不适用

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2025年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
412
试验地点
2
主要终点
Perinatal Healthcare Engagement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

BUNDLE Intervention

Experimental

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.

干预措施: BUNDLE (Other)

Usual Care

Active Comparator

Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.

干预措施: Usual Care (Other)

结局指标

主要结局

Perinatal Healthcare Engagement

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Palatnik, MD

Associate Professor

Medical College of Wisconsin

研究点 (2)

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