Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: BUNDLE, Usual Care.
- Кому может быть актуально
- Состояния в реестре: Pregnancy Related. Базовые параметры: 18 лет — 65 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое BUNDLE
An integrated model of community-based doulas and clinical obstetric providers - Другое Usual Care
Standard of care for pregnancy and pregnancy-related issues by the obstetric provider
Первичные конечные точки
- Perinatal Healthcare Engagement [Срок оценки: From study enrollment and until 12 months postpartum]
Вторичные конечные точки (9)
- Trust in Provider [Срок оценки: Baseline; third trimester, and postpartum]
- Reported Discrimination [Срок оценки: Baseline, third trimester and postpartum]
- Perceived Stress [Срок оценки: Baseline, third trimester and postpartum]
- Depression [Срок оценки: Baseline, third trimester and postpartum]
- Cesarean birth [Срок оценки: At study completion]
- Unplanned healthcare utilization [Срок оценки: Up to 12 months postpartum]
- Severe Maternal Morbidity [Срок оценки: Up to 12 months postpartum]
- Breastfeeding Initiation [Срок оценки: Up to 12 months postpartum]
- Group-Based Medical Mistrust Scale [Срок оценки: Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Medical College of Wisconsin — Milwaukee
Идентификаторы
NCT: NCT05993689 · PRO00047801