# Enhance Trial-Enriched Holistic Care to Eradicate Maternal Morbidity

> **NIH NIH R01** · UNIVERSITY OF PENNSYLVANIA · 2024 · $776,006

## Abstract

Project Summary
This randomized controlled trial
(SMM)
people
 addresses social and structural inequities to reduce severe maternal morbidity
 and maternal mortality in the most at-risk patients – those that self-identify as Black, indigenous and
 of color (BIPOC). Specifically, our intervention will implement and evaluate an integrated, multi-level
maternity care home model (MCHM) that incorporates maternity care navigation, benefits navigation, social
work, doula and mental health resources all within one care-delivery model. While
evaluated
these
 previous studies have
 single social eterminants (e.g. education and insurance) or single solutions (e.g. care navigator),
approaches lack a comprehensive, integrated approach that is responsive to all patient needs.
d
Our study will test our central hypothesis that a patient-centered MCHM will address the gap in social, structural,
and health system factors that contribute to disparities for our most vulnerable BIPOC patients, thereby reducing
SMM. Totest the effectiveness of this MCHM and ensure timely uptake of the results, we propose a type 1 hybrid
effectiveness-implementation trial to evaluate the effectiveness and implementation of an integrated MCHM that
provides a comprehensive approach by partnering a unified model of social and structural service delivery with
medical service delivery in all prenatal offices affiliated with the two largest birthing hospitals in Philadelphia.
Within this study we will determine the effectiveness of an integrated MCHM in reducing SMM among BIPOC
patients (Aim 1). Patients will be randomized (n=2300) to a MCHM (office-based prenatal care that is integrated
with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced
social services referrals) and followed throughout pregnancy and for 1 year postpartum. To determine
mechanisms by which this integrated MCHM impacts SMM (Sub-Aim 1a), we will evaluate numerous factors that
could plausibly mitigate the effects of health system failures, provider bias and adverse social conditions (e.g.
improved health system access, care coordination). We will also characterize patient, provider and organizational
implementation determinants relevant to an integrated MCHM and identify barriers and facilitators to
implementation and sustainability (Aim 2) as well as determine resource utilization and total cost/cost savings
associated with the MCHM (Sub-Aim 2a) by partnering with commercial and Medicaid payers.
Importantly,
delivery
intrapartum
the results of the proposed study will provide actionable evidence to support effective maternity care
 that results in optimal and equitable outcomes, thereby revolutionizing the way in which prenatal,
 and postpartum care is delivered and experienced. Additionally, even if the trial is negative in
reducing SMM, there are still numerous other potential benefits to an integrated MCHM (including many of the
secondary outcomes we are evalua...

## Key facts

- **NIH application ID:** 10828385
- **Project number:** 5R01NR020975-02
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** LISA Danielle LEVINE
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $776,006
- **Award type:** 5
- **Project period:** 2023-04-13 → 2028-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10828385

## Citation

> US National Institutes of Health, RePORTER application 10828385, Enhance Trial-Enriched Holistic Care to Eradicate Maternal Morbidity (5R01NR020975-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10828385. Licensed CC0.

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