The Telehealth MOM Study: Protocol for a randomized controlled trial of the Telehealth Multi-component Optimal Model (MOM) of postpartum care

Background

A substantial proportion of maternal morbidity and mortality occurs in the postpartum period. In 2018, the American College of Obstetricians and Gynecologists (ACOG) published new guidelines recommending that all women have contact with a maternity care provider by 3 weeks postpartum. Although this revised schedule addresses the evident need for enhanced postpartum care, it has not been tested in a clinical trial and implementation has been hampered by logistical and financial constraints. The goal of this study is to evaluate the effect on postpartum outcomes of the Telehealth Multi-Component Optimal Model (MOM) of postpartum care, which delivers the early postpartum visit through telehealth.

Design

We will conduct a type 1 hybrid effectiveness-implementation trial of the Telehealth MOM postpartum care model. This randomized-controlled trial will enroll 1500 diverse pregnant women at five obstetric clinics across Arkansas. We will randomize participants 1:1 to receive enhanced standard of care or the Telehealth MOM model, with remote monitoring of blood pressure and temperature for 14 days postpartum and a telehealth screening for complications between 6 and 14 days after birth. Outcomes are obtained from health records (postpartum visit completion, early detection of complications, readmissions) and surveys at 9 weeks, 6 months, and 13 months postpartum. Qualitative interviews with patients, providers, and study staff will inform development of an implementation blueprint.

Conclusion

This study will contribute much needed evidence regarding the effectiveness of telehealth and remote monitoring in the early postpartum period and can inform policies and strategies for implementing the 2018 postpartum care guidelines.