Introduction

Benzodiazepines and sedative-hypnotics are classes of medications that have been used for decades to treat various psychiatric conditions. However, despite their efficacy, their use has been associated with a number of adverse events. The use of benzodiazepines and sedative-hypnotics (eg, zolpidem, zaleplon) in the elderly increases the risk of adverse events due to the multiple medical comorbidities, pharmacokinetic changes, and polypharmacy typically present in this population.¹ The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults² recommends that all short- and long-acting benzodiazepine and sedative-hypnotic drugs used for the treatment of insomnia be avoided in older adults due to an excessive risk of delirium, falls, fractures, and motor vehicle accidents. The use of benzodiazepines in the elderly is associated with an increased risk of amnestic and nonamnestic cognitive impairment and impaired short-term memory.³ Long-term benzodiazepine use may also increase the risk of dementia although this association remains controversial.^4,5 In 2016, a prospective population-based cohort study⁶ on patients 65 years and older without dementia did not find an association between the highest level of benzodiazepine use and dementia or cognitive decline. The use of sedative-hypnotics has been associated with an increased risk of dementia and fall-related injuries, including traumatic brain injury and hip fractures in elderly patients.^7,8 Despite the adverse events associated with and guidance against benzodiazepine and sedative-hypnotic use in the elderly, their use is not uncommon. Benzodiazepines represent one of the most prevalent inappropriately prescribed medication classes in the United States. A recent population-level retrospective observational study⁹ of benzodiazepine use in the United States revealed that 31.4% of adults aged 65–80 reported chronic use. Given the aforementioned risks associated with benzodiazepine and sedative-hypnotic use, the Department of Veterans Affairs Psychotropic Drug Safety Initiative has issued guidance to minimize the exposure of elderly patients to the side effects and adverse events associated with use of benzodiazepines and sedative-hypnotics. Academic detailing programs have been implemented to inform providers of the risks associated with benzodiazepine and sedative-hypnotic use in elderly veterans.¹⁰

Many efforts have been made to reduce the use of benzodiazepines in the elderly. A meta-analysis of trials detailing interventions for reducing benzodiazepine use in the elderly revealed that both a medication review with consultation as well as a supervised withdrawal schedule augmented with psychotherapy were effective.¹¹ Although effective, these strategies can prove resource-intensive and impractical to implement in all practice settings. In 2014, a randomized controlled trial conducted on older adults (ages 54–72, median age 65) compared the efficacy of structured interventions with follow-up visits versus structured interventions with written instructions. The trial revealed that both interventions led to significant reductions in long-term benzodiazepine use without significant adverse effects.¹² In an effort to increase patient participation in the reduction of their benzodiazepine use, a direct-to-patient education program was developed and studied by Tannenbaum et al.¹³ The EMPOWER trial employed the use of an 8-page booklet based on social constructivist learning and self-efficacy therapy. Unique design elements incorporated into the intervention included self-assessment regarding risks, presentation of evidence, knowledge statements designed to create cognitive dissonance, education regarding drug interactions, peer champion stories, suggestions for substitutes, and stepwise tapering recommendations. This direct-to-consumer education led to either discontinuation or dose reduction in more than a third of patients who received the empowerment intervention.¹³ Despite the success of this intervention, it was conducted on Canadian citizens and may not be generalizable to an elderly veteran population.

The purpose of this pilot project was to determine the effectiveness of a direct-to-consumer educational intervention in reducing benzodiazepine and/or sedative-hypnotic use in an elderly veteran sample. Compared to the EMPOWER trial intervention, this project utilized a more concise, 2-page, tailored intervention written on a 6th grade reading level. It was designed to highlight the negative consequences of benzodiazepine and sedative-hypnotic use while encouraging communication with providers regarding alternatives. The project explored the effect this intervention had on the facilitation of a therapeutic conversation between provider and patient regarding the need to reduce exposure to benzodiazepines and/or sedative-hypnotics and the development of a specific taper plan to achieve this goal. The intervention was designed to facilitate the adaptation and ultimate utilization of this intervention by other providers. This project was approved by the local pharmacy and therapeutics committee and determined to be a quality improvement project.

Methods

Based on the intervention utilized in the EMPOWER trial, a 2-page letter detailing the risks of benzodiazepine and sedative-hypnotic use was developed and approved by the local patient education committee. Specific to veterans, the letter described the Department of Veterans Affairs Psychotropic Drug Safety Initiative and the risks associated with the patient's specific benzodiazepine and/or sedative-hypnotic. The veteran was encouraged to speak to his provider about alternatives. To ensure patient safety, the letter encouraged veterans not to abruptly stop taking their medication without discussion with their provider. The letter was sent to veterans aged 75 or older (Figure 1) with an appointment scheduled with their mental health provider within the next month. After the scheduled appointment, the providers of these patients were contacted via encrypted e-mail (Figure 2) within 1 week after the appointment and asked to complete a follow-up survey. Providers were asked whether the educational material prompted the patient to initiate a conversation regarding his medication. They were also asked if they discussed tapering the patient's benzodiazepine and/or sedative-hypnotic therapy and whether a specific taper plan was developed. After the appointment, the computerized patient record system was accessed to verify dose reduction via medication order.

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Veterans were included in the study if they were aged 75 or older and filled a 30-day supply of a benzodiazepine and/or a sedative-hypnotic by a mental health provider as identified by the Psychotropic Drug Safety Initiative database. Scheduled appointments between the dates of November 1, 2016, and April 30, 2017, were analyzed. Patients were excluded if their medication was being used to treat a seizure disorder.

Results

Fifty-nine patients met inclusion criteria and received letters, and none were excluded based on indication. Fifteen patients either cancelled or did not show for their scheduled appointments. Forty-four follow-up e-mails were sent to providers per protocol, and 27 responses were received.

All patients were male with ages ranging from 75 to 90 years with an average age of 81 years. Medication utilization by this cohort included 12 patients prescribed alprazolam, 16 prescribed clonazepam, 3 prescribed diazepam, 13 prescribed lorazepam, 1 prescribed oxazepam, 2 prescribed temazepam, and 12 prescribed zolpidem.

Of the 27 e-mail responses received, the intervention resulted in a dose reduction in 6 patients (22%). Two of the patients who experienced a dose reduction were prescribed clonazepam, 2 prescribed zolpidem, 1 prescribed lorazepam, and 1 prescribed alprazolam. Based on the responses received from providers, 67% of patients initiated a conversation about their medication. Providers reported that they discussed reducing the dose in 74% of the patient cases. A specific plan to taper the dose was developed in 56% of the cases.

Discussion

Upon receipt of the intervention, 22% of patients experienced a dose reduction in either their benzodiazepine or sedative-hypnotic. This reduction was observed after 1 visit with their provider after having received the intervention. Data suggests that the intervention enhanced communication between provider and patient. Two thirds of patients who received the intervention discussed their use of benzodiazepines and/or sedative-hypnotics with their provider, resulting in a specific plan to taper being developed in over half. Compared to the EMPOWER trial intervention, this intervention was abbreviated in length and focused on adverse event education and the fostering of communication between provider and patient. Furthermore the end points were measured at 1 month as opposed to 6. The results observed in this project are similar to the 38% reduction in dose that was observed in the EMPOWER trial.¹³ Given the adverse events associated with the use of benzodiazepines and sedative-hypnotics in the elderly, a dose reduction in one-fifth of patients is meaningful for clinical practice.

Limitations of this project include the reliance on provider responses to a follow-up survey. Approximately 40% of providers did not respond, and the impact of the intervention could not be determined in those patients. Also, providers may have answered in ways to cast the best light on their practices, given that the responses to surveys were not anonymous. Before the initiation of the project, providers were made aware that the study would begin, possibly influencing their behavior with their elderly patients. Another limitation to this study involves the lack of longitudinal data on the effectiveness of this intervention. As observed in the EMPOWER trial, dose reductions have occurred as far out as 6 months postintervention.¹³

Future projects should incorporate an expansion of this intervention to include a larger sample size with a more diverse group of prescribers. Studies to identify the specific aspect of the intervention that generates the greatest response could allow for the design of a more efficient intervention. Additional studies comparing the effectiveness of adjunctive direct-to-consumer educational interventions would assist in the development of a comprehensive strategy to reduce patient exposure to benzodiazepines and sedative-hypnotics.

Direct-to-consumer interventions have a role to play in efforts to reduce exposure to benzodiazepines and sedative-hypnotics in elderly populations. Future research into their utility will further clarify this role.