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

NCT06276647 | Completed Results

• 2 other identifiers: 850584R01MD016029
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Maternal Behavior; Postpartum Depression

Keywords

Postpartum

Outcome Measures

Primary Outcomes (1)

• Emergency Department (ED) Visits and Readmissions

  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.

  1-30 days postpartum

Secondary Outcomes (2)

• Ability to Obtain Needed Services

  1-30 days postpartum

• Depressive Symptoms

  1 day-6 months postpartum

Study Arms (2)

Patient Education Pamphlet and Partner Sheet

EXPERIMENTAL

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.

Behavioral: HOME

Standard Postpartum Care

NO INTERVENTION

These patients will receive Standard postpartum care.

Interventions

HOME 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.

Patient Education Pamphlet and Partner Sheet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• Columbia University: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Angelina Malenda
• Organization: University of Pennsylvania

angelina.malenda@pennmedicine.upenn.edu

5514823655

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Obstetrics & Gynecology, Perelman School of Medicine

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 26, 2024
• Study Start: February 20, 2024
• Primary Completion: June 6, 2025
• Study Completion: December 5, 2025
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-01

Locations

US (1)