Clinical trial NCT06245057: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
Official title: The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Morbidity;Perinatal
Keywords: Prenatal care
Disparity
Maternity care home model
Pregnancy home
Severe maternal morbidity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-02-07
Enrollment: 2300
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC)
* Ages 16-55
* Presentation to the hospital in pregnancy - this includes prenatal care or the emergency department
* Plan to deliver at the 2 Penn hospital sites
* Patients must be able to read and understand English or Spanish
* Participants must be willing and able to sign the informed consent form

Exclusion Criteria:

* Unable to provide written consent by being unable to read or sign informed consent.
* Enrolled in ENHANCED Trial in a prior pregnancy
* Already participating in Maternity Care Home Model (MCHM)

Primary outcomes:
measure: Severe Maternal Morbidity (SMM)
timeFrame: Delivery to one year postpartum
Secondary outcomes:
measure: Obstetric outcomes: Mode of delivery
timeFrame: At delivery
measure: Obstetric outcomes: Preterm birth less than 37 weeks
timeFrame: At delivery
measure: Obstetric outcomes: Preterm birth less than 34 weeks
timeFrame: At delivery
measure: Obstetric outcomes: Hypertensive disorders of pregnancy
timeFrame: During pregnancy through 6 weeks postpartum
measure: Composite adverse neonatal outcome
timeFrame: From birth until 4 months after birth
measure: Postpartum visit attendance
timeFrame: From delivery discharge up to 12 weeks postpartum
measure: Edinburgh Postnatal Depression Scale (EPDS) Screening
timeFrame: At delivery and at 3-6 months postpartum
measure: Unscheduled Emergency room/pregnancy triage visits
timeFrame: Post-randomization to 1 year postpartum
measure: Perceived stress scale
timeFrame: Post-randomization to 1 year postpartum
measure: Person centered prenatal care survey for people of color
timeFrame: After delivery up to 6 weeks postpartum
measure: Rate of Lactation initiation and continuation
timeFrame: From delivery through 1 year postpartum
measure: Perceived discrimination
timeFrame: At randomization
measure: Birth satisfaction (BSS-R survey)
timeFrame: After delivery up to 6 weeks postpartum
Other outcomes:
Locations:
city: Phialdelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sindhu K Srinivas, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: