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

N/AEnrolling By InvitationNCT06298214

Elizabeth F Sutton, PhD500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

500

Conditions

Postpartum Pregnancy Related

Eligibility

Sex: FEMALEMin age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Postpartum visit attendance

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

Time frame: 12 weeks postpartum

Secondary Outcomes

Medical trust

Group-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust

Time frame: 12 months postpartum

Health literacy

Rapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy

Time frame: 12 months postpartum

Self-efficacy

PROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy

Time frame: 12 months postpartum

Healthcare costs

total cost of healthcare from Medicaid Claims Database within the first 12 months after delivery

Time frame: 12 months postpartum

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes