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Cucciare MA, Hagedorn HJ, Bounthavong M, Abraham TH, Greene CJ, Han X, Kemp L, Marchant K, White P, Humphreys K. Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol. Contemporary clinical trials communications. 2022 Oct 1; 29:100994.
BACKGROUND: Long-term benzodiazepine dependence carries significant health risks which might be reduced with low-cost patient self-management interventions. A booklet version of one such intervention (Eliminating Medications Through Patient Ownership of End Results; EMPOWER) proved effective in a Canadian clinical trial with older adults. Digitizing such an intervention for electronic delivery and tailoring it to different populations could expand its reach. Accordingly, this article describes the protocol for a randomized controlled trial to test the effectiveness of an electronically-delivered, direct-to-patient benzodiazepine cessation intervention tailored to U.S. military veterans. METHODS: Design: Two-arm individually randomized controlled trial. SETTING: US Veterans Health Administration primary care clinics. PARTICIPANTS: Primary care patients taking benzodiazepines for three or more months and having access to a smartphone, tablet or desktop computer. INTERVENTION AND COMPARATOR: Participants will be randomized to receive either the electronically-delivered EMPOWER (EMPOWER-ED) protocol or asked to continue to follow provider recommendations regarding their benzodiazepine use (treatment-as-usual). MEASUREMENTS: The primary outcomes are complete benzodiazepine cessation and 25% dose reduction, assessed using administrative and self-report data, between baseline and six-month follow-up. Secondary outcomes are self-reported anxiety symptoms, sleep quality, and overall health and quality of life, measured at baseline and 6-month follow-up, and benzodiazepine cessation at 12-month follow-up. COMMENTS: This randomized controlled trial will evaluate whether the accessibility and effectiveness of a promising intervention for benzodiazepine cessation can be improved through digitization and population tailoring.