Supporting Unhealthy Substance use care Through a whole person Approach and user centered INtegration into primary care (SUSTAIN) - PROJECT SUMMARY Over a third of American adults engage in unhealthy substance use (USU), which includes a spectrum ranging from any illicit drug use or alcohol consumption above guideline-recommended levels through more severe substance use disorder. USU results in increased mortality through overdose and substantial morbidity including reduced functioning, poorer chronic disease outcomes and increased health care utilization. A broad range of biological, psychological and social factors contribute to USU. However, while primary care clinicians frequently encounter patients with USU, they rarely screen for, diagnose, or treat USU using a comprehensive approach that would account for all these factors. Furthermore, existing strategies and models to improve USU care frequently fail to consider practice and community context, and thus have not been widely disseminated. In our study, Supporting Unhealthy Substance use care Through a whole person Approach and user centered INtegration into primary care (SUSTAIN), we propose to engage primary care practices and individuals with lived USU experience in codesigning a whole person USU intervention and collaboratively test the implementation of the SUSTAIN intervention in primary care practices. In phase 1 of our study, we will convene a series of stakeholder groups with practice representatives and individuals with USU who will codesign a change package that includes a menu of interventions that considers the psychological, social, and biological factors that contribute to USU. In phase 2, we will conduct a cluster randomized controlled trial with waitlist control in 24 practices with 50 patients each from 2 practice-based research networks, the WWAMI (Washington, Wyoming, Alaska, Montana and Idaho) region Practice and Research Network and the Virginia Ambulatory Care Outcomes Research Network. Participating practices will join a learning collaborative where they will be supported in implementing their customized approach to identifying and treating USU by selecting from the menu of interventions developed in Phase 1. The primary outcome will be patient functioning (measured by the PROMIS-29-v2) and secondary outcomes will include unhealthy substance use (TAPS-1), recovery (RAS), health care utilization and process outcomes. Guided by the Consolidated Framework for Implementation Research (CFIR), we will evaluate implementation outcomes and conduct qualitative interviews with a subset of patients and clinicians. Our proposed intervention will enhance equity since the intervention is adaptable to the needs and preferences of each practice and individuals served by the practice. It is innovative in that it transcends the current focus on implementing a specific model and recognizes and adapts to the diversity of primary care practices in communities served, organizational structures and payment models. If successful, the SUSTAIN model can transform how primary care practices care for individuals with USU in a sustainable and whole person approach, improving patient outcomes and enhancing communities.