Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk (HOME)
Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk: a Pilot Randomized Control Trial
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:
- 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?
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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No Intervention: Standard Postpartum Care
These patients will receive Standard postpartum care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Emergency Department (ED) Visits and Readmissions
Time Frame: 1-30 days postpartum
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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.
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1-30 days postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability to Obtain Needed Services
Time Frame: 1-30 days postpartum
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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. |
1-30 days postpartum
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Depressive Symptoms
Time Frame: 1 day-6 months postpartum
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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
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1 day-6 months postpartum
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 850584
- R01MD016029 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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