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

Not Applicable

Active, not recruiting

• Conditions: Maternal Behavior; Postpartum Depression
• Interventions: Behavioral: HOME

• Registration Number: NCT06276647
• Lead Sponsor: University of Pennsylvania

Brief Summary

The goal of this educational clinical trial is to identify Black 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 high-risk women. The main question\[s\] it aims to answer are:

* How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?

* 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study Start: 2024-02-20
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Education Pamphlet and Partner Sheet	HOME	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.

Primary Outcome Measures

Name	Time	Method
Emergency Department (ED) Visits and Readmissions	1-30 days postpartum	To obtain data for the primary outcome of postpartum morbidity and mortality as measured by Emergency Department (ED) visits and hospital readmissions in the 30-day post discharge period. Investigators will use chart reviews to obtain this ED/Readmission information.

Secondary Outcome Measures

Name	Time	Method
Ability to Obtain Needed Services	1-30 days postpartum	To detect the ability of participants to "obtain needed services" in the 30-day post discharge period as one of the main pathways of unnecessary ED visits. Investigators will measure this outcome by number of times patient is able to reach their doctor or healthcare provider by email, phone, or in-person.; Investigators ask patients three weeks postpartum: "Please rate your ability to do the following on a scale of never-sometimes-often-always: Your ability to get through to the doctor's or midwife's office by phone,Your ability to speak to your provider by phone, Your ability to see your provider if you felt you needed to"
Depressive Symptoms	1 day-6 months postpartum	A score 20 or higher on the Patient Health Questionnaire (PHQ-9: scale ranges from 0-27).; Higher scores indicate worse outcomes.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States