healthy opioid prescription engagement

Conditions: Opioid Misuse; Opioid-Related Disorders; Pharmacist-Patient Relations

Summary: this study is a randomized controlled trial across 14 community pharmacies to test the efficacy of the brief intervention-medication therapy management intervention (bi-mtm). the establishment of the bi-mtm model will result in a major impact for addressing the opioid epidemic, preventing opioid use disorder and overdose, and safeguarding patient health in a novel community-based service setting.

this study examines a community pharmacy-based intervention to reduce opioid medication misuse. despite a recent national decline in opioid prescribing, 10.3 million americans in 2018 reported misusing a prescribed opioid, and within this population, \>36% of those who misused obtained the opioid medication by filling a prescription. the point of medication dispensing, namely, the community pharmacy, is an untapped resource to address prescription opioid misuse-especially when considering the \>60,000 pharmacies employing \>170,000 pharmacists in the us. this study aims to conduct a fully-powered rct of the bi-mtm intervention in community pharmacy settings that will accomplish 3 specific aims. the first aim will demonstrate the pharmacist-led bi-mtm intervention is superior to standard medication counseling (smc) for mitigating opioid medication misuse. this will be accomplished by conducting a powered single-blinded randomized trial to test the efficacy of bi-mtm (n=175) vs. smc (n=175). participants will be screened/recruited for eligibility at point of dispensing in 14 community pharmacies in utah, a high opioid prescribing and opioid-adverse event state. participants will be assessed at baseline, 2, and 6 months for opioid medication misuse. participant-level state prescription drug monitoring data will also be linked with patient outcomes to assess objective changes in medication misuse behaviors (e.g., early refills and doctor/pharmacy shopping). the second aim will identify the pathway by which bi-mtm results in improvements for depression, pain, and subsequently opioid misuse. to accomplish this, a path analysis will assess relationships of bi-mtm: (1) on depression, pain, and misuse, (2) depression on misuse, and (3) pain on misuse. the final aim will explore latent transitions of baseline to post-intervention misuse classes by intervention group. this will be accomplished by using mixture modeling, specifically multi-group latent transition analysis. the observed misuse indicators will be used to estimate latent class transitions across time, grouping by treatment condition and adjusting for baseline covariates. completing sa1- 3 advance the understanding of bi-mtm efficacy and set the stage for a national multisite trial.

Eligibility criteria:
inclusion criteria: * adult (≥18 years) * english speaking * not receiving cancer treatment * who have a positive opioid misuse screen on the pomi will be eligible to learn about this study exclusion criteria: * are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring * can-not provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up) * do not have a reliable land line or mobile phone to be contacted by study staff * are filling only buprenorphine (given some formulations are not indicated for pain) * plan to leave the area for an extended period of time in the next 6 months * have had a psychotic and/or manic episode in the last 30 days (before consent, patients will be asked to screen for psychosis * do not provide permission to access their state prescription drug monitoring data.

Keywords: community pharmacies patient navigation opioid intervention