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Completed

NCT Number: NCT06276647

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

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.

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Key information

Conditions

Maternal Behavior Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Emergency Department (ED) Visits and Readmissions

    Time frame: 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 outcomes

  1. Ability to Obtain Needed Services

    Time frame: 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 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." We score never as 1 and always as 4. If access score is greater than or equal to 11, they are considered having high provider access. Percentage of patients reflects those who had high provider access.

  2. Depressive Symptoms

    Time frame: 1 day-6 months postpartum

    The number of participants in the trial who scored an 11 or higher on the Edinburgh Postnatal Depression Scale (EPDS: a ten-item scale that measures minor or major depression and self-harm through 4-point Likert scale responses. Scores can range from 0-30. Higher scores indicate worse outcomes). The score was ascertained from a Redcap survey including EPDS. For more information see Cox et al. 1987

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk: a Pilot Randomized Control Trial

Acronym: HOME

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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