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.

backgroundUnhealthy 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.

methodsSUSTAIN 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.

conclusionsThe 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.