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

NCT ID: NCT06276647

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2025-12-05

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.

Conditions

Maternal Behavior; Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient Education Pamphlet and Partner Sheet

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.

Group Type: EXPERIMENTAL

HOME

Intervention Type: BEHAVIORAL

The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum patients. The patient navigator will explain this pamphlet at postpartum discharge, then will follow-up with the patients up to 30 days in the postpartum period.

Standard Postpartum Care

These patients will receive Standard postpartum care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HOME

The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum patients. The patient navigator will explain this pamphlet at postpartum discharge, then will follow-up with the patients up to 30 days in the postpartum period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Howell

Chair, Department of Obstetrics & Gynecology, Perelman School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R01MD016029

Identifier Type: NIH

Identifier Source: secondary_id

View Link

850584

Identifier Type: -

Identifier Source: org_study_id