A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
- Conditions
- Preeclampsia PostpartumAdverse Pregnancy Outcomes
- Interventions
- Behavioral: usual postpartum care + community health worker interventionBehavioral: usual postpartum care
- Registration Number
- NCT06353256
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
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.
- Detailed Description
The investigators will adapt a current perinatal community health worker intervention 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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, gestational diabetes, small for gestational infant
- Planning to deliver at UAB Hospital
- Speaks and writes in English
- No indication for delivery at the time of enrollment
- Declines Randomization
- Speaks or writes in languages other than English
- Currently incarcerated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care and community health worker intervention usual postpartum care + community health worker intervention Usual postpartum care and community health worker visits and support Usual Care usual postpartum care Usual postpartum care
- Primary Outcome Measures
Name Time Method Acceptability 12 weeks Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10).
- Secondary Outcome Measures
Name Time Method Patient satisfaction with CHW intervention 6-12 weeks postpartum Patient satisfaction with CHW intervention using Sekhon Questionnaire to Assess the Acceptability of Healthcare Interventions, 1-5 scale with 1 being the lowest acceptability to 5 being the highest acceptability.
Secondary Outcome Measure: Primary Care Visit Scheduled 6-12 weeks postpartum Participant reports at least one visit is scheduled with a primary care provider
Secondary Outcome Measure: Mean Blood Pressure 6-12 weeks postpartum Mean blood pressure at 6-12 weeks postpartum
Trial Locations
- Locations (2)
UAB Medicine
🇺🇸Birmingham, Alabama, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States