Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol

Michael A Cucciare, Hildi J Hagedorn, Mark Bounthavong, Traci H Abraham, Carolyn J Greene, Xiaotong Han, Lakiesha Kemp, Kathy Marchant, Penny White, Keith Humphreys, Michael A Cucciare, Hildi J Hagedorn, Mark Bounthavong, Traci H Abraham, Carolyn J Greene, Xiaotong Han, Lakiesha Kemp, Kathy Marchant, Penny White, Keith Humphreys

Abstract

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.

Keywords: Benzodiazepine dependence; Digital; Protocol; Self-management; Smartphone app; Veterans.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this manuscript.

Figures

Fig. 1
Fig. 1
Flowchart of procedure.
Fig. 2
Fig. 2
Self-assessment of risks associated with long-term benzodiazpine use and education on potential harms.
Fig. 3
Fig. 3
Vignettes of peers who have successfully stopped using benzodiazepines.
Fig. 4
Fig. 4
Evidence-based alternatives to benzodiazepines for helping with sleep or anxiety.

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Source: PubMed

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