Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial

Background: >1 in 3 of the 9 million individuals engaged in opioid medication misuse obtain legitimate opioid prescriptions and fill these in community pharmacies, which are subsequently misused. This study is testing the efficacy of a pharmacist-led intervention-Brief Intervention-Medication Therapy Management (BI-MTM)- compared to standard medication counseling (SMC) to address opioid medication misuse. Methods: Design. This study is a single-blinded 2-group parallel randomized trial within 13 community pharmacies that will enroll 350 individuals. Participant Recruitment. Pharmacy staff approach patients and ask about interest in completing a brief confidential screening tool, which includes opioid medication misuse assessment. Interested patients who report misuse are asked to provide informed consent. Enrolled patients are assessed for behavioral and physical health at enrollment, 2-months post-enrollment, and 6-months post-enrollment. Interventions. Following baseline assessment, participants are randomized (1:1 ratio) to: SMC, a medication information/counseling intervention or BI-MTM, an intervention comprised by 4 evidence-based components: medication therapy management, brief intervention, naloxone dispensing, and patient navigation. Analyses. Primary analyses involve estimating 3-level generalized linear mixed models to relate repeated assessments across time of opioid medication misuse (i.e., the Prescription Opioid Misuse Index) to the intervention. Conclusion: Study results will provide the first critical step towards integrating a highly accessible, low-cost approach to managing risks related to opioid use. Community pharmacies provide an incredibly important setting in which patients can receive high quality care to support health behavior change. Successfully completing this project sets the stage for a large-scale effectiveness study. (NCT#: NCT05141266).