Implementation of a Digitally Enhanced Intervention to Retain Pregnant and Postpartum People with Opioid Use Disorder in Buprenorphine Treatment - Opioid-related overdose is the leading cause of maternal mortality, despite availability of lifesaving treatments. Opioid agonist medications, such as buprenorphine, effectively treat opioid use disorder (OUD) and prevent overdose. Yet, over half of pregnant women who receive buprenorphine discontinue in the postpartum year. Multiple challenges hinder buprenorphine engagement among pregnant and postpartum women (PPW). No known intervention directly targets buprenorphine retention in PPW and such an intervention is urgently needed. Dr. Witcraft’s pilot data, including feedback from PPW with OUD, informed the development of an intervention explicitly designed to enhance buprenorphine retention in PPW: EMPWR (EMpowering Pregnant Women Receiving medications for OUD). The complementary research and training plans proposed in this K23 application will advance Dr. Witcraft towards her long-term goal to develop adaptable, scalable, and sustainable interventions to reduce opioid-related overdoses among PPW. The overall objective of this research project is to evaluate feasibility and implementation of EMPWR into routine practice, and to preliminarily characterize clinical outcomes. This objective will be achieved through two specific aims: (1) evaluate feasibility of EMPWR and (2) measure EMPWR implementation outcomes. Under the first aim, a randomized controlled feasibility trial of EMPWR vs. medication monitoring (N=30) with a hybrid type I effectiveness-implementation approach will be conducted with baseline (prenatal), 3-, and 6-month postpartum assessments. For the second aim, implementation outcomes will be assessed via mixed methods, including synthesis of qualitative interviews guided by the Consolidated Framework for Implementation Research (CFIR) determinant framework, and quantitative signals for implementation outcomes evaluated with the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework. The research plan directly corresponds with Dr. Witcraft’s training goals in: 1) implementation science; 2) clinical trial methodology; 3) buprenorphine retention barriers; 4) clinical trial, longitudinal, and mixed methods data analysis; and 5) advancement of grantsmanship and scientific skills. Several activities will ensure training goals are met, including mentorship from nationally recognized experts across each of the training domains, participation in didactic and applied training activities, and application of skills through the research project. Dr. Witcraft’s faculty appointment is at the Medical University of South Carolina, which has an excellent research environment and robust facilities and resources that are ideally suited for mentored career development in substance use disorder research. This K23 award would allow Dr. Witcraft to establish expertise in each of these intersecting research areas, represents a clear progression from previous training, and serves as the next logical step in her research. This award would equip her with a range of critical skills necessary to achieve a high-impact and federally funded research portfolio, and lead to a follow-on R01 multisite hybrid effectiveness-implementation trial of EMPWR in varied practice settings.
