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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy Related; Postpartum
• Intervention / Treatment: Behavioral: Her Health Program

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Woman's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Subjects will see doctors as normal during first year postpartum with no assistance.
Experimental: 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.	Behavioral: Her Health Program; Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum visit attendance	Visit attended between 6-12 weeks of delivery (yes/no)	12 weeks postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Elizabeth F Sutton, PhD
• Collaborators: Donaghue Medical Research Foundation
• Investigators: Principal Investigator: Elizabeth Sutton, PhD, Woman's Hospital, Louisiana

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RP-23-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No