Clinical trial NCT06481631: Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare
Official title: Empowering Women for Postpartum Care and Reproductive Health in Mississippi Delta
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Family Dynamics
Trust in Healthcare System
Family Structure
Health Literacy
Contraception
Maternal Behavior
Postpartum Mood Disturbance
Lead sponsor: Jackson State University
Sponsor class: OTHER
Collaborators: name: Mississippi State Department of Health
name: University of Mississippi Medical Center
name: Harvard School of Public Health (HSPH)
First posted: 2024-07-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trial with one arm.
Primary purpose: PREVENTION

Brief summary: Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities.

These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.

Detailed description: Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This research center will conduct two multi-layered research projects. Research Project 1 will determine the effectiveness of an evidenced-based community health worker home visiting program grounded in extensive patient and community participation. Research Project 2 will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity care.

Eligibility criteria: Inclusion Criteria:

* Identified as high risk pregnancy
* Postpartum mothers/parents 18-45 years
* Resident of the one of 5 target counties (Washington, Bolivar, Scott, Humphreys, and Carroll)
* Maternal healthcare providers in target counties
* Maternal community health leaders

Exclusion Criteria:

* not identified as high risk pregnancy
* 18 years of age postpartum
* cesarean birth
* non-resident of the 5 target counties

Primary outcomes:
measure: Improve trust in the healthcare system
timeFrame: 12 months from consent to participate
measure: Increase maternal health literacy (patient and provider perspectives)
timeFrame: 12 months from consent to participate in the intervention
measure: Increase engagement in the maternal health care system (patient-clinic linkages)
timeFrame: 12 month from consent to participation in the intervention
measure: Strengthen structuring of family support systems
timeFrame: 12 months from consent to participation in the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jackson State University
name: Mary Shaw, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jackson State University
name: Girmay Berhie, PhD
role: STUDY_DIRECTOR
References: