Deconstructing Maternal Burdens: Doulas and the Community Unite for Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Evaluating the Effectiveness of UNITE Intervention
研究概览
简要总结
This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more frequently, and continues through the first year after birth, versus the standard doula care currently covered by Medicaid in Florida.
The study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services.
The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety symptoms compared to standard doula support, while gathering data on real-world implementation. The study also evaluates the effectiveness of Medicaid-covered doula services more broadly, with findings intended to inform state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.
详细描述
Women in the US have not reaped the benefits of the decline in worldwide maternal mortality (MM) rates (maternal deaths per 100,000 live births) as pregnancy-related deaths (death of a woman while pregnant or within 1 year of the end of a pregnancy) have increased steadily for the past 3 decades. The incidence of perinatal depression and anxiety disorders is high in the US. An estimated 1 out of 7 to 10 pregnant women and 1 out of 5 to 8 postpartum women will develop depressive and/or anxiety disorder.
A doula is a non-medical person who provides informational, physical and emotional support to patients and their support persons. The support doulas provide may be instrumental in supporting maternal wellbeing and navigation of the healthcare system to obtain needed medical care. However, research on doulas have focused primarily on pregnancy and birth. Evidence as to the effectiveness of doula care in the postpartum is scant. This proposal will contribute to the sparse high-level evidence to support the use and expansion of doula services to improve health for low-income families.
This is a pragmatic, two-arm, Type 1 Effectiveness-Implementation Hybrid randomized controlled trial evaluating an enhanced doula support model, UNITE, against standard Medicaid covered doula care, in a socially high-risk population. Pregnant individuals in the study catchment area will be randomized to one of two groups: standard Medicaid doula care, or UNITE doula care, which adds more visits starting earlier in pregnancy, more frequent visits near the due date, several extended home visits in the first two months postpartum, and continued check-ins through the first year after birth. UNITE participants will be engaged in clinic or home settings, in person and/or virtually, and will receive emotional and physical support, education, referrals to community resources, and screening for risk factors for adverse outcomes.
The study also builds the doula workforce it depends on. Through the UNITE Doula Collective, doulas are trained, supported to bill Medicaid, and mentored by an experienced doula network.
Participants in both arms will complete surveys at five time points from pregnancy through one year postpartum to assess the intervention's effectiveness. The primary outcome is a composite measure of perinatal depressive and anxiety symptoms. Secondary outcomes include psychosocial measures, maternal morbidity and mortality, clinical and birth outcomes, and knowledge of pregnancy warning signs. Implementation outcomes include reach, adoption, fidelity, and adaptation, will also be assessed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •15-49 years old
- •14-28 weeks pregnant
- •Medicaid Eligible
- •Resides in North Central Florida
排除标准
- •Severe physical or mental health conditions that Interfere with participation
研究组 & 干预措施
Enhanced Doula Support
Participants with Medicaid insurance will receive an enhanced doula support, which adds more visits starting earlier in pregnancy, more frequent visits near the due date, several extended home visits in the first two months postpartum, and continued check-ins through the first year after birth.
干预措施: Doula (Other)
Standard Medicaid Doula Support
Participants with Medicaid insurance will receive standard Medicaid doula support only.
干预措施: Standard (non-enhanced) Medicaid doula support (Other)
结局指标
主要结局
Evaluating the Effectiveness of UNITE Intervention
时间窗: 4-6 weeks postpartum
The primary outcome is a composite measure of perinatal depressive and/or anxiety symptoms. Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), with a score greater than 9 indicating clinically significant symptoms; the EPDS ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms. As well as the Generalized Anxiety Disorder 7-item Scale (GAD-7), ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
次要结局
- Perinatal Depressive Symptoms(Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum)
- Perinatal Anxiety Symptoms(Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum)
- Perceived Stress(Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum)
- Social Support(Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum)
- Medical Mistrust(Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum)
- Birth Experience(4-6 weeks postpartum)
- Breastfeeding Rates(4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum)