Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk (HOME)

University of Pennsylvania

Status: Active, not recruiting

Conditions: Maternal Behavior; Postpartum Depression

Treatments: Behavioral: HOME

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06276647

850584

R01MD016029 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this educational clinical trial is to identify high-need women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for these high-need patients.

The main question[s] it aims to answer are:

1. How can the investigators help postpartum patients who have poor outcomes by decreasing the number of ED visits/readmissions for these patients within the first 30 days postpartum?
2. How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?

Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum.

Enrollment: 214 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postpartum patients who have delivered a baby at the Hospital of University of Pennsylvania
• Ages 18 or older
• Self-identify as Black (listed on chart)
• Speak English
• Able to read
• Other characteristics defined by our risk prediction model (algorithm)

Exclusion criteria

• Unable to provide informed consent
• Speaks a language other than English

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Patient Education Pamphlet and Partner Sheet

Experimental group

Description:

The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources.

Treatment:

Behavioral: HOME

Standard Postpartum Care

No Intervention group

Description:

These patients will receive Standard postpartum care.