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

Postpartum Depression Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276647
• Other study ID #: 850584
• Secondary ID: R01MD016029
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Micki Burdick, PhD
• Phone: 716-432-2558
• Email: micki.burdick[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: May 31, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression, Postpartum
• Maternal Behavior
• Postpartum Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Columbia University, National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ability to Obtain Needed Services	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"	1-30 days postpartum
Secondary	Depressive Symptoms	A score 11 or higher on the Edinburgh Postnatal Depression Scale (EPDS: a scale that ranges from 0-30), or suicidal ideation as indicated by the EPDS (If the answer to the question "The thought of harming myself has occurred to me" is: "Yes, quite often" or "sometimes," Higher scores indicate worse outcomes.	1 day-6 months postpartum
Secondary	Depressive Symptoms	A score 20 or higher on the Patient Health Questionnaire (PHQ-9: scale ranges from 0-27).; Higher scores indicate worse outcomes.	1 day-6 months postpartum