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

Empowering Women for Postpartum Care and Reproductive Health in Mississippi Delta

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.

Study Overview

• Status: Recruiting
• Conditions: Contraception; Maternal Behavior; Health Literacy; Family Dynamics; Postpartum Mood Disturbance; Trust in Healthcare System; Family Structure
• Intervention / Treatment: Behavioral: The PEN-3 Intervention Model

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Shaw, PhD; Phone Number: 601-979-3103; Email: mary.shaw@jsums.edu
• Study Contact Backup: Name: Girmay Berhie, PhD; Phone Number: 601-979-1184; Email: girmay.berhie@jsums.edu

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39213
      • Recruiting
      • Jackson State University/Department of Behavioral & Environmental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PEN-3 Assessment Model; Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve trust in the healthcare system	Mixed methods approach using Trust in Physician Scale & Researcher developed qualitative tool	12 months from consent to participate
Increase maternal health literacy (patient and provider perspectives)	Brief literacy screening tool to evaluate health literacy in the health system (Qualitative and Quantitative Measures	12 months from consent to participate in the intervention
Increase engagement in the maternal health care system (patient-clinic linkages)	Contraceptive Counseling measure tool to evaluate the patient experiences with provider care and vice-versa; minimally 2 post-partum clinec visits in postpartum period	12 month from consent to participation in the intervention
Strengthen structuring of family support systems	Family crisis coping response (F-COPES) measure to determine patient (mother) and family perceptions and experiences with structuring family support fo postpartum care period.	12 months from consent to participation in the intervention

Collaborators and Investigators

• Sponsor: Jackson State University
• Collaborators: Harvard School of Public Health (HSPH); University of Mississippi Medical Center; Mississippi State Department of Health
• Investigators: Principal Investigator: Mary Shaw, PhD, Jackson State University; Study Director: Mary Shaw, PHD, M.ED, Jackson State University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1U54HD113238-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No