Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare

NCT ID: NCT06481631

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2030-06-30

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.

Conditions

Family Dynamics; Trust in Healthcare System; Family Structure; Health Literacy; Contraception; Maternal Behavior; Postpartum Mood Disturbance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PEN-3 Assessment Model

Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes

Group Type: OTHER

The PEN-3 Intervention Model

Intervention Type: BEHAVIORAL

The PEN-3 Model is a sociocultural model for planning and assessing participant behavior within the context a cultural phenomenon. It will be used to assess intervention impact on patient-clinical linkages in the Mississippi Delta.

Interventions

The PEN-3 Intervention Model

The PEN-3 Model is a sociocultural model for planning and assessing participant behavior within the context a cultural phenomenon. It will be used to assess intervention impact on patient-clinical linkages in the Mississippi Delta.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mississippi State Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Jackson State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Shaw, PhD

Role: PRINCIPAL_INVESTIGATOR

Jackson State University

Mary Shaw, PHD, M.ED

Role: STUDY_DIRECTOR

Jackson State University

Locations

Jackson State University/Department of Behavioral & Environmental Health

Jackson, Mississippi, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Shaw, PhD

Role: CONTACT

mary.shaw@jsums.edu

601-979-3103

Girmay Berhie, PhD

Role: CONTACT

girmay.berhie@jsums.edu

601-979-1184

Other Identifiers

1U54HD113238-02

Identifier Type: NIH

Identifier Source: org_study_id

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