Enhance Trial-Enriched Holistic Care to Eradicate Maternal Morbidity

University Of Pennsylvania, Philadelphia PA

Investigators

Linked publications, trials & patents

Abstract

This randomized controlled trial addresses social and organizational differences to reduce severe maternal morbidity (SMM) and maternal mortality in the most at-risk patients). 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 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. Our study will test our central hypothesis that a patient-centered MCHM will address the gap in social, organizational, and health system factors that contribute to differences in outcomes between low and high risk individuals, thereby reducing SMM. To test the effectiveness of this MCHM and ensure timely implementation 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 organizational 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 high-risk 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, the results of the proposed study will provide actionable evidence to support effective maternity care delivery that results in optimal and balanced 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 we are evaluating) and we will have therefore collected valuable information to inform the implementation of this model into clinical practice.