by Hallie Butler, Doctor of Pharmacy Candidate, University of Mississippi School of Pharmacy
Review and Analysis of: Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of Inappropriate Benzodiazepine Prescriptions Among Older Adults Through Direct Patient Education: The EMPOWER Cluster Randomized Trial. JAMA Intern Med. 2014;174(6):890–898.
Shared decision making has been encouraged because it not only uses evidence but also considers the patient’s preferences and values to help choose the most effective therapy. The American Board of Internal Medicine initiated the Choosing Wisely campaign to assist providers and patients when deciding which therapies should be discontinued. The idea is that we need to de-escalate or discontinue therapies in older adults, those older than 65 years of age, that are unnecessary or may cause harm. The American Geriatrics Society took part in this campaign and they recommend against the use of benzodiazepines as a treatment for insomnia in older adults. The reason: benzodiazepines cause cognitive impairment and drastically increase the risk of falls and fractures. Unfortunately, benzodiazepines are commonly prescribed. While research has consistently shown that the risks of benzodiazepines in the elderly far outweigh their benefits, older adults are more likely to be prescribed medications from this class than younger adults.2 Even though physicians are aware of the risks of benzodiazepines, more than 50% of them continue to prescribe them to their older patients. The objective of the EMPOWER trial was to implement and measure the effectiveness of a direct-to-patient education program for older adults receiving long-term benzodiazepine therapy. In this study, they assessed rates of dose reduction and cessation of benzodiazepine use.1
This study was a 2-arm, parallel-group, pragmatic cluster randomized control trial. Thirty community pharmacies participated. These pharmacies had at least 20% or more of their patients age 65 or older. There were 303 participants in this study ranging in age from 65 to 95 years old. The pharmacies were randomly assigned to either the intervention or control groups. All of the participants including the pharmacists, patients, evaluators, and prescribers were all blinded to the outcome assessment. To be eligible for this study, the patient had to have at least 5 active prescriptions with at least one being a benzodiazepine. They also had to receive a refill of a benzodiazepine for three consecutive months prior to study enrollment. Patients that had a diagnosis of severe mental illness or dementia, had a current prescription for an antipsychotic and/or cholinesterase inhibitor or memantine in the previous three months, or who were a resident of a long term care facility, were excluded. 1
The educational intervention included a booklet on self-efficacy and social learning theory. Each of the participants completed a self-assessment about their opinions on benzodiazepine use and then received information on the harms associated with their use. Knowledge statements were presented with the purpose of creating a cognitive dissonance regarding the safety of benzodiazepine use. The participants were also educated on certain drug interactions and listened to peer champion stories to promote self-efficacy. The study team discussed with the patients about treatment options that were equally or more effective substitutions and educated them on how to taper off their benzodiazepine. The taper schedule was based on a 21-week protocol. The protocol was picture-based and showed the diminishing dose from a full pill to half pill, and finally a quarter pill. The participants were encouraged to speak with their providers and/or pharmacist about deprescribing. All of the reading material was written at a sixth-grade level and in 14 point font.1 This should make it accessible to nearly all participants. The control group received usual care and there was no active effort to educate these participants about the risks of benzodiazepine use.
The complete cessation of benzodiazepine use in six months was the primary outcome. In order to be classified as complete cessation, the patient must have had no benzodiazepine prescriptions or renewals at the time of the six-month follow-up and sustained for at least three consecutive months. The investigators verified this using pharmacy profiles. The study team defined a dose reduction as at least 25% or more reduction in dose compared to baseline for at least three consecutive months. Every participant had a complete follow-up at their pharmacy in six months. One research nurse and one investigator, who was blinded to group allocation, used a protocol to independently assess the outcomes.1
Complete cessation was achieved in 27% of participants vs 5% in controls. There was an 8-fold higher probability of participants who received the intervention to discontinue benzodiazepine therapy. In addition, 11% of the intervention group reduced their benzodiazepine dose. This study suggests that teaching adults with an evidence-based approach, in a way that makes them question the safety and necessity of benzodiazepine use, is a safe and effective method to address over-prescribing. In previous studies that did not include a direct patient educational program, efforts to have physicians deprescribe benzodiazepine had a smaller impact.
Systematically recruiting participants through community pharmacies is just one of the many strengths of this study.1 Some other strengths would be the blinding of all participants and how they objectively assessment of drug discontinuation rates. I believe one weakness of this study was the six-month time frame for patient follow-up. With a longer follow-up period, the intervention could have proven to be more or less effective — there might have been a higher discontinuation rate or, perhaps, there might have been a high relapse rate.
Educators should pay attention to this particular study for several reasons. The patient education techniques these researchers used had a significant impact on patient behavior. This is a major accomplishment as many older adults are very reluctant to stop benzodiazepine use.2 The educational intervention was well designed. It included different forms of instruction and promoted self-efficacy. Promoting self-efficacy can help patients improve other chronic illnesses as well such as hypertension and diabetes. Patients must believe that they can make a difference in their health outcomes. A picture-based drug-tapering protocol is a great instructional tool because it is friendly to all ages, languages, and health literacy levels. A larger font should also be used when distributing materials to older adults as many of them have visual impairments. The strategies employed in this study can be used in a wide array of disease states and can be used as a model to get patients more involved in their care.
- Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of Inappropriate Benzodiazepine Prescriptions Among Older Adults Through Direct Patient Education: The EMPOWER Cluster Randomized Trial. JAMA Intern Med.2014;174(6):890–898.
- Pereto A. Data: Seniors prescribed benzodiazepines most often. Athena Health. Accessed November 25, 2020.
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