Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Morbidity;Perinatal Clinical Trial

— ENHANCED  

Official title:

The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245057
• Other study ID #: 853430
• Secondary ID: 1R01NR020975-01
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Sindhu K Srinivas, MD, MSCE
• Phone: 215-662-2982
• Email: ssrinivas[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Morbidity;Perinatal

Intervention

Other:
• Maternity care home model (MCHM)
The maternity care home model is defined as office based prenatal care integrated with comprehensive social services.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe Maternal Morbidity (SMM)	The CDC definition of SMM. We will also include postpartum hemorrhage, infection, thrombosis, readmission and maternal mortality within this definition	Delivery to one year postpartum
Secondary	Obstetric outcomes: Mode of delivery	Vaginal or cesarean	At delivery
Secondary	Obstetric outcomes: Preterm birth less than 37 weeks	Preterm delivery defined as less than 37 weeks	At delivery
Secondary	Obstetric outcomes: Preterm birth less than 34 weeks	Preterm delivery defined as less than 34 weeks.	At delivery
Secondary	Obstetric outcomes: Hypertensive disorders of pregnancy	Diagnosis of Gestational hypertension, preeclampsia with or without severe features	During pregnancy through 6 weeks postpartum
Secondary	Composite adverse neonatal outcome	Made up of one or more of the following: severe respiratory distress syndrome, Culture proven/presumed neonatal sepsis, Neonatal blood transfusion, Hypoxic ischemic encephalopathy, Intraventricular hemorrhage grade 3 or 4, Necrotizing enterocolitis, Need for head cooling,	From birth until 4 months after birth
Secondary	Postpartum visit attendance	Whether or not the patient attended their routine postpartum visit up to 12 weeks postpartum mark.	From delivery discharge up to 12 weeks postpartum
Secondary	Edinburgh Postnatal Depression Scale (EPDS) Screening	Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items. A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen	At delivery and at 3-6 months postpartum
Secondary	Unscheduled Emergency room/pregnancy triage visits	Record number of unscheduled visits, reason for visit, whether or not patient was admitted to hospital.	Post-randomization to 1 year postpartum
Secondary	Perceived stress scale	Scores from the validated Perceived Stress Scale (PSS-4) will be calculated using standard scoring criteria for each of the 4 items. Higher scores are correlated with more perceived stress.; Survey to be completed at randomization, at delivery, at 3 months post partum, and at 1 year post partum.	Post-randomization to 1 year postpartum
Secondary	Person centered prenatal care survey for people of color	Scores from this 34-item scale will be calculated using standard scoring criteria. This scale measures person-centered prenatal care that reflects the experiences of people of color.	After delivery up to 6 weeks postpartum
Secondary	Rate of Lactation initiation and continuation	Initiation of breastfeeding; Continuation of breastfeeding through 1 year postpartum. To be assessed by EMR documentation and patient report at 3-months and 1 year postpartum.	From delivery through 1 year postpartum
Secondary	Perceived discrimination	Perceived discrimination will be assessed using the Experiences of Discrimination measure (Krieger et al, 2005). The measure lists 9 situations in which respondent may have experienced racial discrimination. Responses options are Yes/No. It is scored by counting the number of situations in which participant reported experiencing racial discrimination. Score ranges from 0 to 9, higher being more experiences of discrimination.	At randomization
Secondary	Birth satisfaction (BSS-R survey)	Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction	After delivery up to 6 weeks postpartum