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

NCT06298214 | Enrolling By Invitation

• 1 other identifier: RP-23-019
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Postpartum visit attendance

  Visit attended between 6-12 weeks of delivery (yes/no)

  12 weeks postpartum

Secondary Outcomes (4)

• Medical trust

  12 months postpartum

• Health literacy

  12 months postpartum

• Self-efficacy

  12 months postpartum

• Healthcare costs

  12 months postpartum

Study Arms (2)

Usual Care

NO INTERVENTION

Subjects will see doctors as normal during first year postpartum with no assistance.

Her Health Program

EXPERIMENTAL

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

Interventions

Her Health Program BEHAVIORAL

Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.

Her Health Program

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elizabeth F Sutton, PhD: lead
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Location

Study Officials

• Elizabeth Sutton, PhD

  Woman's Hospital, Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Scientific Research

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 7, 2024
• Study Start: May 29, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (1)