This K01 award application is for Dr. Elizabeth Siantz, a PhD-trained social worker whose overarching career goal is to become an independent clinical investigator who uses implementation science to promote the adoption and integration of evidence-based Chronic Disease Self-Management programs for persons with chronic disease, primarily opioid use disorder (OUD) and serious mental illness (SMI). This K01 will support four key areas of career development: 1) intervention adaptation as it relates to the mental health and primary care needs of persons with OUD; 2) training in clinical trial design and management in real-world settings; 3) advanced skills for qualitatively evaluating intervention implementation; and 4) strengthening research leadership with a focus on gender equity and diversity in science. Dr. Siantz has assembled an interdisciplinary mentoring team comprised of Adam Gordon, MD (Primary Mentor), who is an expert dissemination and implementation (D&I) researcher focused on improving quality of care to vulnerable patient populations with OUD; and Leopoldo Cabassa, PhD, MSW (co-mentor), an expert mixed-methods D&I researcher focused on promoting the physical health of persons with SMI. Additional advisors include: Gerald Cochran, PhD, MSW, a clinical trialist with OUD expertise; Lawrence Palinkas, PhD, an expert in mixed-method designs for D&I research; Angela Presson, PhD, an expert in clinical trials statistical analyses; and Angela Fagerlin, PhD, an expert in patient decision support interventions and in gender equity and diversity in research leadership. People with OUD have a high co-occurrence of serious mental illness (SMI) and other chronic diseases, and are often challenged by their clinical symptoms and social vulnerabilities. While primary care settings frequently treat patients with OUD and SMI, primary care providers have few tools to support this population in self-managing these complex health conditions. Chronic Disease Self-Management programs (CDSMPs) can improve disease management skills and behaviors, but have not been adapted for primary care patients with OUD and SMI. Un-adapted versions might lack relevance to this population and setting. Dr. Siantz will address this implementation gap. This research will support a future hybrid-effectiveness study to test the adapted CDSMP for primary care patients with OUD and SMI. This study’s Specific Aims include: 1) Adapt the CDSMP for adults with OUD and SMI for implementation in a primary care setting using the Collaborative Intervention Planning Framework; 2) Test the feasibility, acceptability, and initial impact of the adapted CDSMP for persons with SMI and OUD in a primary care setting; and 3) Evaluate implementation process and context of the adapted CDSMP using Rapid Assessment Method Informed Clinical Ethnography. This proposed research is significant because it will develop a health education resource for a population at high risk for early mortality. The proposed research is innovative because it will extend an existing CDSMP to a new patient population (persons with OUD and SMI) and novel setting (primary care).

The Chronic Disease Self-Management program (CDSMP) is shown to improve disease self-management skills and behaviors in a range of clinical populations. I propose to adapt the CDSMP for primary care patients with opioid use disorder (OUD) and serious mental illness (SMI), assess its feasibility and acceptability in a small randomized trial, qualitatively evaluate its implementation in a primary care environment using the Rapid Assessment Procedure Informed Clinical Ethnography procedure. I will also engage in career development and training activities that will enhance my expertise in adapting, implementing, and testing of a CDSMP for persons with OUD and SMI.