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

TL;DR

An electronic tool helped patients stop using benzodiazepines more effectively than usual care, showing promise for reducing long-term use of these drugs.

Contribution

Demonstrated that a patient-directed electronic intervention can replicate the success of a paper-based approach in reducing benzodiazepine dependence.

Findings

The electronic intervention increased benzodiazepine cessation odds by 5.31 times compared to usual care.

The intervention did not significantly increase the odds of a 25% dose reduction.

The tool is low-cost, self-administered, and freely accessible.

Abstract

Could the benefits of a patient-focused self-management intervention promoting benzodiazepine cessation be replicated in a second trial that converted it from paper and pencil to electronic format?

In this randomized clinical trial of 161 primary care patients, the odds of benzodiazepine cessation at 6-month follow-up was 5.31 times higher among those who received the intervention than those not receiving the intervention, a significant difference, and the odds of at least a 25% reduction in benzodiazepine dose was 2.51 times higher in the intervention group, a nonsignificant difference.

This study suggests that a freely accessible, patient-directed website tool can aid benzodiazepine cessation.

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

This randomized clinical trial examines whether the benefits of a patient-focused self-management intervention promoting benzodiazepine cessation could be replicated when the intervention was converted from paper and pencil to electronic format.

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