Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-03-17 @ 11:11 PM
Study NCT ID:
NCT06245057
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENHANCED
Brief Summary:
The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients.
The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM.
Participants will be randomized 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 during pregnancy through 1 year postpartum.
The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM.
Participants will be randomized 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 during pregnancy through 1 year postpartum.
Detailed Description:
This randomized controlled trial addresses social and structural inequities to reduce severe maternal morbidity (SMM) and maternal mortality in the most at-risk patients - those that self-identify as Black, indigenous and people of color (BIPOC). Specifically, the 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 previous studies have evaluated single social determinants (e.g. education and insurance) or single solutions (e.g. care navigator), these approaches lack a comprehensive, integrated approach that is responsive to all patient needs.
The study will test the central hypothesis that a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable BIPOC patients, thereby reducing SMM. To test the effectiveness of this MCHM and ensure timely uptake of the results, the investigators 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, the investigators 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), the investigators 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). The investigators 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, the results of the proposed study will provide actionable evidence to support effective maternity care delivery that results in optimal and equitable outcomes, thereby revolutionizing the way in which prenatal, intrapartum 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 being evaluated) and the investigators will have therefore collected valuable information to inform the implementation of this model into clinical practice.
The study will test the central hypothesis that a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable BIPOC patients, thereby reducing SMM. To test the effectiveness of this MCHM and ensure timely uptake of the results, the investigators 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, the investigators 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), the investigators 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). The investigators 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, the results of the proposed study will provide actionable evidence to support effective maternity care delivery that results in optimal and equitable outcomes, thereby revolutionizing the way in which prenatal, intrapartum 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 being evaluated) and the investigators will have therefore collected valuable information to inform the implementation of this model into clinical practice.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01NR020975-01 | NIH | None | https://reporter.nih.gov/quic… | View |