Overview of trial design
overdose, OUD
BLIND, PCP
The STOP trial is a cluster randomized controlled trial that tests the efficacy of the STOP intervention to reduce opioid use and overdose risk, and to prevent progression of OUD in adult patients with risky opioid use over the course of 12 months, as compared to EUC. It is being conducted within the NIDA Clinical Trials Network, as part of the NIH Helping to End Addiction Long-term (HEAL) Initiative.[The STOP intervention is a collaborative care model consisting of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports the PCP in engaging and monitoring patients who have risky opioid use; (2) brief advice delivered to patient participants by their PCP and/or prerecorded video message from a study investigator (LG) about health risks of opioid misuse; and (3) at least 2 sessions, and up to 6 sessions, of telephone health coaching to motivate and support behavior change amongst patient participants.Prior to enrollment, patients are informed that their PCP is participating in a “healthy living study” and are blinded to both the study condition of their PCP and the focus of the study (risky opioid use). After enrollment it is possible that they may be able to deduce their PCP’s assignment, but this information will not be volunteered by clinical or research staff. To assess the success of the blind, patient participants will be asked at their last study visit what they considered to be the goal of the research. Patient participants are assessed through multiple modalities, including monthly brief surveys sent via text message and email, structured questionnaires delivered over the phone and via a web-based portal at baseline and quarterly for 12 months, and urine drug screens at baseline, 6 and 12 months. PCP prescribing and monitoring behaviors are assessed from the electronic health record (EHR) as well as self-administered questionnaires regarding attitudes and behaviors on opioid prescribing. An independent commercial Institutional Review Board (IRB) approved the study, and all sites ceded to this central IRB Fig. Basic Study Schema