Electronic Intervention for Patient-Managed Benzodiazepine Tapering: A Randomized Clinical Trial.

Abstract

More than 30 million people in the US take prescribed benzodiazepines, which, when taken long-term, carry risks of falls, cognitive decline, and dependence. A previous trial showed that a patient-focused self-management intervention (Eliminating Medications Through Patient Ownership of End Results; EMPOWER) can reduce long-term benzodiazepine dependence use and the risks that accompany it. To replicate the finding of the EMPOWER trial after converting the intervention from printed materials to electronic format. This 2-arm, individually randomized clinical trial with a 6-month follow-up was conducted at US Veterans Health Administration primary care clinics in 2 Veterans Affairs health care systems. Participants included 161 primary care patients taking benzodiazepines for 3 or more months and having access to a smartphone, tablet, or desktop computer. Recruitment occurred from June 1, 2022, to January 31, 2024. Participants were randomized to either the electronically delivered EMPOWER (EMPOWER-ED) protocol or asked to continue to follow clinician recommendations regarding their benzodiazepine use (treatment as usual). Preregistered primary outcomes were complete benzodiazepine cessation and at least 25% dose reduction at 6-month follow-up, assessed using pharmacy data. Secondary outcomes were self-reported anxiety symptoms, sleep quality, and overall health and quality of life. Analysis was performed on an intent-to-treat basis. The 161 participants had a mean (SD) age of 61.9 (13.7) years and were mostly male (134 [83.2%]). Individuals assigned to the EMPOWER-ED group had a significantly greater likelihood of complete benzodiazepine cessation (odds ratio [OR], 5.31 [95% CI, 1.12-25.12]). There was no likelihood of at least a 25% dose reduction in the EMPOWER-ED group relative to the control group (OR, 2.51 [95% CI, 0.91-6.90]). No statistically significant difference was found between the 2 groups for the secondary outcomes. This randomized clinical trial found a large effect of a low-cost, self-administered electronic intervention for reducing benzodiazepine use among long-term users. Findings from this replicated clinical trial are encouraging given the prevalence of benzodiazepine dependence and the constraints on clinician time available to address it. Dissemination of this intervention-which is in the public domain-by health care and public health systems seems warranted. ClinicalTrials.gov Identifier: NCT04572750.