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

Elizabeth F Sutton, PhD

Status: Invitation-only

Conditions: Pregnancy Related; Postpartum

Treatments: Behavioral: Her Health Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06298214

RP-23-019

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

Her Health Program

Experimental group

Description:

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.

Treatment:

Behavioral: Her Health Program