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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06481631
• Lead Sponsor: Jackson State University

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Study Start: 2025-01-01
• Primary Completion: 2029-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEN-3 Assessment Model	The PEN-3 Intervention Model	Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes

Primary Outcome Measures

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