The rate of maternal mortality in the United States is higher than any other developed country and there are significant racial, geographic and socioeconomic disparities in these deaths and in maternal morbidity. The Alliance for Innovation on Maternal Health (AIM) safety bundles for Postpartum Discharge Transition and Reduction of Peripartum Racial and Ethnic Disparities provide a well-established, consistent and standardized approach to delivering evidence-based practices to improve early detection of and timely care for postpartum complications necessary to reduce maternal morbidity and mortality.
The standard of care (SOC) is for healthcare providers is to employ the Reduction of Peripartum Racial and Ethnic Disparities AIM safety bundle throughout prenatal and postpartum care and deliver the content of the Postpartum Discharge Transition AIM safety bundle following delivery and prior to hospital discharge. However, following hospital discharge, these evidence-based safety bundles are not being followed or put into action. Listening to Women and Pregnant and Postpartum People (LTWP) is a patient-and-provider-informed, text-/phone-based complex intervention that supports effective implementation of these AIM safety bundles outside of the hospital and during the early postpartum period. LTWP works by: 1) increasing the identification of early warning signs/symptoms of postpartum complications by employing frequent text-message screenings; 2) utilizing an Obstetric Nurse Navigator (ONN) who can proactively monitor and accurately interpret these screenings, remove barriers to care and quickly connect patients to timely and appropriate resources and treatment; 3) having ONNs employ a shared decision making process to support patient-centered referrals and 4) having an ONN to advocate for patients and provide timely and tailored responses to inequitable and/or disrespectful care.
The long-term goal of this research is to reduce maternal morbidity and mortality associated with undetected and untreated early postpartum complications, particularly for low-income, rural and minority populations. The objective of this current application is to determine the effectiveness of LTWP compared to the SOC in reducing the need for emergency department (ED) visits for neglected or unnecessarily escalated postpartum complications and improving patient-centered patient-reported outcomes (PROs) at six weeks, and 3, 6, 9 and 12 months postpartum.
The study design is a randomized controlled trial and each participant will have a 50/50 chance of receiving LTWP or SOC. The study population includes postpartum women 16-45 years of age, insured by Medicaid, admitted to the Medical University of South Carolina Mother-Baby (postpartum) Unit following the delivering of a live birth and consenting to longitudinal follow-up with plans to continue their residence in South Carolina for the duration of the postpartum year. Both groups will receive the Postpartum Discharge Transition and Reduction of Peripartum Racial and Ethnic Disparities AIM safety bundles in-person as part of the Mother-Baby Unit SOC. The study team hypothesizes that compared to the SOC, those assigned to LTWP will have reduced rates of postpartum ED visits zero to six weeks postpartum (primary outcome) and at 3, 6, 9 and 12 months postpartum (secondary outcomes) as measured by Medicaid claims data. The study team will also determine differences in PROs (i.e., discrimination in health care, maternal well-being and functioning, depressive symptoms and substance use) at six weeks and 3, 6, 9 and 12 months postpartum (secondary outcomes). The anticipated target sample size is n=2,894 (Medicaid claims data) and n=2,170 (PROs) with a 98 percent and 25 percent attrition rate, respectively. LTWP is a complex intervention; therefore, the study team will apply a rigorous process evaluation to determine LTWP reach and fidelity and facilitators and barriers to implementation and capacity for sustainability of LTWP in trial and non-trial delivery hospitals.
Throughout all phases of the study, the study team will include patient partners, community and national organizations, clinicians, scientists, healthcare system representatives, payers and policy makers with vested interests in this work. The study team will convene a Patient Stakeholder Group and Study Advisory Committee to seek input and all opinions about the research and research procedures and ensure that outcomes are meaningful to patients. The study team will determine the intervention that is best for patients and groups of patients as well as characteristics that determine the likelihood that LTWP is successfully used. Results from the study will help patients, providers, hospitals, payers and health systems decide how best to improve early detection and timely care for postpartum complications, particularly for low-income, rural and minority populations.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.