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

Not Applicable

Active, not recruiting

• Conditions: Maternal Behavior; Postpartum Depression

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

Brief Summary

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.

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
• Primary Completion: 2025-06-06
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-08
• Study Completion: 2025-12-05

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

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
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.
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"

Trial Locations

Locations (1)

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