Alabama Womb 2 Heart Solution (AW2H): A Community Health Worker Intervention to Improve Short- and Long-term Outcomes in Black Patients With Adverse Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Acceptability
研究概览
简要总结
United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.
详细描述
The investigators will adapt a current perinatal community health worker intervention, lead by a leading community health worker organization, Connection Health, to the unique needs of Black postpartum patients with preeclampsia and other adverse pregnancy outcomes. The investigators will conduct a pilot trial to assess the feasibility and acceptability of the intervention. The hypothesis is that it is possible to randomize eligible patients to the feasibility trial, and the intervention will be acceptable to participants. The investigators will randomize Black postpartum patients with preeclampsia or other adverse pregnancy outcomes to either 1) usual care - cardiovascular disease-prevention education before discharge, or 2) intervention - cardiovascular disease prevention education before discharge plus an adapted Connection Health community health worker intervention. Following the completion of this project, the investigators intend to conduct a larger postpartum community health worker intervention trial in patients with preeclampsia or other adverse pregnancy outcomes powered to detect a difference in clinically meaningful outcomes, as informed by our existing community advisory board.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 56 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self Identifies as Black
- •Between 16-56 years old
- •Experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant
- •Planning to deliver at UAB Hospital
- •Speaks and writes in English
排除标准
- •Declines Randomization
- •Speaks or writes in languages other than English
- •Currently incarcerated
- •Previously enrolled in P3OPPY
研究组 & 干预措施
Usual Care
Usual postpartum care
干预措施: usual postpartum care (Behavioral)
Usual care and community health worker intervention
Usual postpartum care and community health worker visits and support
干预措施: usual postpartum care + community health worker intervention (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 12 weeks
Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10).
Participant Satisfaction With Postpartum Support
时间窗: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.
Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10). Participant satisfaction with postpartum support received as part of the study, measured on a 1 to 10 scale where 1 = lowest satisfaction and 10 = highest satisfaction. Higher scores represent greater satisfaction (a better outcome).
次要结局
- Patient satisfaction with CHW intervention(6-12 weeks postpartum)
- Secondary Outcome Measure: Primary Care Visit Scheduled(6-12 weeks postpartum)
- Secondary Outcome Measure: Mean Blood Pressure(6-12 weeks postpartum)
- Patient Satisfaction With CHW Intervention(Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.)
- Primary Care Visit Scheduled(Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.)
- Mean Blood Pressure(Measured at the in-person postpartum clinic visit, occurring anytime between 6 and 12 weeks postpartum.)
研究者
Jesse Rattan
Principal Investigator
University of Alabama at Birmingham