TY - JOUR AU - C. B. Simon AU - J. B. Britz AU - B. Keiser AU - E. M. Brooks AU - A. H. Krist AU - N. Franko AU - B. Webel AU - M. A. Hatch AU - J. I. Tsui AU - K. A. Stephens AU - S. T. Tong A1 - AB - BACKGROUND: Unhealthy substance use (USU) is common and ranges from use above guideline-recommended levels to severe substance use disorder. USU results in substantial morbidity and mortality yet primary care practices rarely systematically screen, diagnose, and treat USU. Supporting Unhealthy Substance use care Through a whole person Approach and user centered INtegration into primary care (SUSTAIN) tests whether the implementation of a co-designed change package for USU improves patient function. The protocol for SUSTAIN is presented here. METHODS: SUSTAIN is a cluster randomized controlled implementation trial of a customized approach to identify and treat USU in primary care. The sample includes 24 primary care clinics in two practice-based research networks (PBRNs). In phase one, primary care practice champions and patients with lived USU experience co-design a change package to identify and treat USU. In phase two, we test the effectiveness of the change package versus usual care and evaluate the implementation of the change package. Data will be collected from 24 clinics (50 patients per clinic for total of 1200 patients) through patient surveys and the electronic health record. Patients surveyed must be 18 or older and screen positive for USU using the Tobacco, Alcohol, Prescription medication and other Substance use part one (TAPS-1) tool. Primary outcomes include mental and physical health patient function scales measured using Patient Reported Outcomes Measurement Information System (PROMIS-29-v2). Secondary outcomes are prevalence of USU, recovery, health care utilization, USU screening rates, provision/referral to behavioral health services and prescription of appropriate medications. We will also evaluate implementation outcomes by surveying 96 practice representatives (4 at each clinic) and conduct qualitative interviews with 20 patients and 20 practice leaders to assess their experience with the intervention and its implementation. CONCLUSIONS: The SUSTAIN trial creates and tests an implementation package approach to address USU in diverse primary care settings. The SUSTAIN change package aims to transform how primary care practices care for individuals with USU to improve patient outcomes and enhance community well-being. AD - Department of Family Medicine, University of Washington, United States of America. Electronic address: clairebs@uw.edu.; Department of Family Medicine and Population Health, Virginia Commonwealth University, United States of America.; Department of Family Medicine, University of Washington, United States of America.; Addictions, Drug & Alcohol Institute, Department of Psychiatry & Behavioral Sciences, University of Washington, United States of America.; Department of Medicine, Division of General Internal Medicine, University of Washington, United States of America.; Department of Family Medicine, University of Washington, United States of America; Department of Biomedical Informatics & Medical Education, University of Washington, United States of America. AN - 39870354 BT - J Subst Use Addict Treat C5 - Opioids & Substance Use DA - Apr DO - 10.1016/j.josat.2025.209626 DP - NLM ET - 20250125 JF - J Subst Use Addict Treat LA - eng N2 - BACKGROUND: Unhealthy substance use (USU) is common and ranges from use above guideline-recommended levels to severe substance use disorder. USU results in substantial morbidity and mortality yet primary care practices rarely systematically screen, diagnose, and treat USU. Supporting Unhealthy Substance use care Through a whole person Approach and user centered INtegration into primary care (SUSTAIN) tests whether the implementation of a co-designed change package for USU improves patient function. The protocol for SUSTAIN is presented here. METHODS: SUSTAIN is a cluster randomized controlled implementation trial of a customized approach to identify and treat USU in primary care. The sample includes 24 primary care clinics in two practice-based research networks (PBRNs). In phase one, primary care practice champions and patients with lived USU experience co-design a change package to identify and treat USU. In phase two, we test the effectiveness of the change package versus usual care and evaluate the implementation of the change package. Data will be collected from 24 clinics (50 patients per clinic for total of 1200 patients) through patient surveys and the electronic health record. Patients surveyed must be 18 or older and screen positive for USU using the Tobacco, Alcohol, Prescription medication and other Substance use part one (TAPS-1) tool. Primary outcomes include mental and physical health patient function scales measured using Patient Reported Outcomes Measurement Information System (PROMIS-29-v2). Secondary outcomes are prevalence of USU, recovery, health care utilization, USU screening rates, provision/referral to behavioral health services and prescription of appropriate medications. We will also evaluate implementation outcomes by surveying 96 practice representatives (4 at each clinic) and conduct qualitative interviews with 20 patients and 20 practice leaders to assess their experience with the intervention and its implementation. CONCLUSIONS: The SUSTAIN trial creates and tests an implementation package approach to address USU in diverse primary care settings. The SUSTAIN change package aims to transform how primary care practices care for individuals with USU to improve patient outcomes and enhance community well-being. PY - 2025 SN - 2949-8767 (Print); 2949-8759 SP - 209626 ST - Supporting Unhealthy Substance use care Through a whole person Approach and user centered INtegration into primary care (SUSTAIN): Study protocol for a type 2 hybrid effectiveness-implementation trial T1 - Supporting Unhealthy Substance use care Through a whole person Approach and user centered INtegration into primary care (SUSTAIN): Study protocol for a type 2 hybrid effectiveness-implementation trial T2 - J Subst Use Addict Treat TI - Supporting Unhealthy Substance use care Through a whole person Approach and user centered INtegration into primary care (SUSTAIN): Study protocol for a type 2 hybrid effectiveness-implementation trial U1 - Opioids & Substance Use U3 - 10.1016/j.josat.2025.209626 VL - 171 VO - 2949-8767 (Print); 2949-8759 Y1 - 2025 ER -