Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.

BACKGROUND: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. METHODS: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

Leveraging technology to address unhealthy drug use in primary care: Effectiveness of the Substance use Screening and Intervention Tool (SUSIT).

Background: Screening for unhealthy drug use is now recommended for adult primary care patients, but primary care providers (PCPs) generally lack the time and knowledge required to screen and deliver an intervention during the medical visit. To address these barriers, we developed a tablet computer-based 'Substance Use Screening and Intervention Tool (SUSIT)'. Using the SUSIT, patients self-administer screening questionnaires prior to the medical visit, and results are presented to the PCP at the point of care, paired with clinical decision support (CDS) that guides them in providing a brief intervention (BI) for unhealthy drug use. Methods: PCPs and their patients with moderate-risk drug use were recruited from primary care and HIV clinics. A pre-post design compared a control 'screening only' (SO) period to an intervention 'SUSIT' period. Unique patients were enrolled in each period. In both conditions, patients completed screening and identified their drug of most concern (DOMC) before the visit, and completed a questionnaire about BI delivery by the PCP after the visit. In the SUSIT condition only, PCPs received the tablet with the patient's screening results and CDS. Multilevel models with random intercepts and patients nested within PCPs examined the effect of the SUSIT intervention on PCP delivery of BI. Results: 20 PCPs and 79 patients (42 SO, 37 SUSIT) participated. Most patients had moderate-risk marijuana use (92.4%), and selected marijuana as the DOMC (68.4%). Moderate-risk use of drugs other than marijuana included cocaine (15.2%), hallucinogens (12.7%), and sedatives (12.7%). Compared to the SO condition, patients in SUSIT had higher odds of receiving any BI for drug use, with an adjusted odds ratio of 11.59 (95% confidence interval: 3.39, 39.25), and received more elements of BI for drug use. Conclusions: The SUSIT significantly increased delivery of BI for drug use by PCPs during routine primary care encounters.