Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester

Not Applicable

• Conditions: Postpartum; Pregnancy Related
• Interventions: Behavioral: Her Health Program

• Registration Number: NCT06298214
• Lead Sponsor: Elizabeth F Sutton, PhD

Brief Summary

The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.

The main question\[s\] the study aims to answer are:

* Can the Her Health program increase access to healthcare in the first year postpartum?

* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?

Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.

Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-07
• Study Start: 2024-05-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• At least 16 years old at the time of consent.
• Gave birth within 7 days before randomization
• Medicaid enrolled
• Address of residence within a disadvantaged area (ADI>5).
• Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent

Exclusion Criteria

• Use of private health insurance exclusively
• Does not speak English.
• Plans to move out of state during the study time period
• Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records.
• Unwilling to provide informed consent
• Unwilling to be randomized.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Her Health Program	Her Health Program	Her Health is a patient navigation intervention delivered by community health workers across the first postpartum year. Her Health has two interspersed components: Navigation and Education. Her Health Navigation is delivered through weekly and monthly check-ins between participant and navigator. Her Health navigators will deliver historically informed and culturally competent education designed to promote self-efficacy and self-advocacy within the healthcare system.

Primary Outcome Measures

Name	Time	Method
Postpartum visit attendance	12 weeks postpartum	Visit attended between 6-12 weeks of delivery (yes/no)

Secondary Outcome Measures

Name	Time	Method
Health literacy	12 months postpartum	Rapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy
Self-efficacy	12 months postpartum	PROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy
Healthcare costs	12 months postpartum	total cost of healthcare from Medicaid Claims Database within the first 12 months after delivery
Medical trust	12 months postpartum	Group-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust

Trial Locations

Locations (1)

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States