IMPORTANCE: 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.
OBJECTIVE: To replicate the finding of the EMPOWER trial after converting the intervention from printed materials to electronic format.
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTION: 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).
MAIN OUTCOMES AND MEASURES: 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.
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04572750.
| Discipline Area | Score |
|---|---|
| Family Medicine (FM)/General Practice (GP) |  |
| General Internal Medicine-Primary Care(US) | |
| Psychiatry | |
| FM/GP/Mental Health | |
Good study but unclear how this would work in a different patient population.
This is an important study. The State where I practice has a definite problem with benzo prescribing; however, as the Medical Examiner for one of the largest counties for OD deaths in the State (accidental or intentional), I feel I would have a biased assessment.
I have two methodologic concerns: 1. there is no information on the indications for the participants who had been prescribed benzodiazepines (anxiety, insomnia, muscle pain, restless leg syndrome, etc). 2. My bigger concern though is that the control group was not appropriately chosen. The experimental group are advised about risk of continuing the meds and how to taper off. The control group are provided neither. So, of course more participants in the experimental group tapered off! A fairer control group would be participants advised by their usual prescriber how to taper off. Otherwise, we cannot judge whether the outcome was specific to the particular intervention.
