Analysis
SECONDARY, PCP
A mixed effects negative binomial model with a log link will be fit to estimate the difference in mean number of days of risky opioid use in the past 6 months between treatment and control groups. The model will include random PCP intercepts to account for within-PCP correlation of participant response values, fixed site effects to account for within-site correlation of responses, a fixed treatment effect, and the baseline value of the response variable (days of use within 30 days prior to the baseline assessment timepoint), which may improve precision. Letting YThe primary analysis will be performed on the Intention-to-Treat (ITT) principle, analyzing patient participants according to their randomization assignment regardless of potential exposure to the opposite assignment. The primary analysis will use multiple imputations to account for missingness of the primary outcome variable. The imputation model will incorporate information on days of risky use from the timeline follow back surveys. Further details of the imputation model will be specified in the Statistical Analysis Plan, which will be finalized prior to the primary analysis is performed. A secondary analysis will be performed on the Per Protocol (PP) population. This population will exclude patient participants who had appointments with PCPs in the opposite treatment arm. The primary outcome will be evaluated using a two-sided test with a type I error rate of 5%.Secondary analyses of the primary outcome include the model used in the primary analysis adjusted for individual-level covariates which may be associated with the response.