Contemporary clinical trials communications · 2022
Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol.
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Cucciare Michael A, Hagedorn Hildi J, Bounthavong Mark, Abraham Traci H, Greene Carolyn J, Han Xiaotong, Kemp Lakiesha, Marchant Kathy, White Penny, Humphreys Keith
Аннотация
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.
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.