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Evaluation of a multicomponent intervention consisting of education and feedback to reduce benzodiazepine prescriptions by general practitioners: The BENZORED hybrid type 1 cluster randomized controll

['Caterina Vicens', 'Balearic Health Service Ibsalut Son Serra-La Vileta Healthcare Centre', 'Palma', 'Illes Balears', 'Research Network On Chronicity', 'Primary Care', 'Health Promotion', 'Ricapps -Balearic Islands Health Research Institute', 'Idisba', 'Mallorca']

Date: 2022-05

A multicomponent intervention that targeted GPs and included educational meeting, feedback about BZD prescriptions, and a support web page led to a statistically significant reduction of BZD prescriptions and fewer long-term users. Although the effect size was small, the high prevalence of BZD use in the general population suggests that large-scale implementation of this intervention could have positive effects on the health of many patients.

Forty-nine GPs (21 intervention group and 28 control group) were lost to follow-up. However, all GPs were included in the ITT analysis. After 12 months, there were a statistically significant decline in total BZD prescription in the intervention group compared to the control group (mean difference: −3.24 DDDs per 1,000 inhabitants per day, 95% confidence interval (CI): −4.96, −1.53, p < 0.001). The intervention group also had a smaller number of long-term users. The adjusted absolute difference overall was −0.36 (95% CI: −0.55, −0.16, p > 0.001), and the adjusted absolute difference in long-term users over age 65 years was −0.87 (95% CI: −1.44, −0.30, p = 0.003). A key limitation of this clustered design clinical trial is the imbalance of some baseline characteristics. The control groups have a higher rate of baseline BZD prescription, and more GPs in the intervention group were women, GPs with a doctorate degree, and trainers of GP residents.

We conducted a multicenter two-arm, cluster randomized controlled trial in 3 health districts in Spain (primary health centers [PHCs] in Balearic Islands, Catalonia, and Valencian Community) from September 2016 to May 2018. The 81 PHCs were randomly allocated to the intervention group (n = 41; 372 GPs) or the control group (n = 40; 377 GPs). GPs were not blinded to the allocation; however, pharmacists, researchers, and trial statisticians were blinded to the allocation arm. The intervention consisted of a workshop about the appropriate prescribing of BZDs and tapering-off long-term BZD use using a tailored stepped dose reduction with monthly BZD prescription feedback and access to a support web page. The primary outcome, based on 700 GPs (351 in the control group and 349 in the intervention group), compared changes in BZD prescriptions in defined daily doses (DDDs) per 1,000 inhabitants per day after 12 months. The 2 secondary outcomes were the proportion of long-term users (≥6 months) and the proportion of long-term users over age 65 years.

Current benzodiazepine (BZD) prescription guidelines recommend short-term use to minimize the risk of dependence, cognitive impairment, and falls and fractures. However, many clinicians overprescribe BZDs and chronic use by patients is common. There is limited evidence on the effectiveness of interventions delivered by general practitioners (GPs) on reducing prescriptions and long-term use of BZDs. We aimed to evaluate the effectiveness of a multicomponent intervention for GPs that seeks to reduce BZD prescriptions and the prevalence of long-term users.

Funding: CV received funding from The Carlos III institute from the Ministry of Economy and Competitiveness (grant number PI15/01480). IS received a grant for completing the Doctoral thesis by the Spanish Society of Family and Community Medicine (semFYC.) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2022 Vicens et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Introduction

Clinicians mainly prescribe benzodiazepines (BZDs) to treat anxiety and insomnia, or as adjuvants for treatment of depression [1]. Clinical guidelines advocate short-term use of BZDs [2,3] because long-term use leads to tolerance and dependence and is associated with many adverse effects, including somnolence, daytime drowsiness, memory disruption [4–6], increased risk of falls resulting in hip fracture [7–9], and motor vehicle accidents [10,11]. Other studies expressed concerns about possible links of long-term BZD use with mortality [12,13]. Long-term BZD use is particularly inappropriate for older people [14]. However, many clinicians overprescribe BZDs and chronic use is common [15,16]. Overall number of prescriptions of BZDs and BZD-like drugs (Z-drugs) has modestly decreased over the last 10 years in Europe [17]. The prevalence of BZD use varies greatly among countries and ranges from less than 15 defined daily doses (DDDs) per 1,000 inhabitants per day in the United Kingdom, the Netherlands, and Germany, to more than 85 DDDs per 1,000 inhabitants per day in countries such as Iceland, Portugal, and Spain [18].

The Spanish Medicine Agency (AEMPS) reported an average of 87.6 DDDs per 1,000 inhabitants per day during 2018 [19]. According to the most recent Spanish health survey, an average of 10% of the population in Spain reported consuming a BZD during the 2 weeks prior to the survey. Women and aged 65 years or more were the highest consumers (36%) [20].

Most BZDs are mainly prescribed by general practitioners (GPs). The high variability in prescribing BZDs among practices [21] can be explained local health policies regarding the prescription of BZDs, internal conditions of the healthcare practices, and beliefs and attitudes of the GPs regarding the benefits and risks of BZDs [22–24].

Some authors consider that discussing benefits and risk with the patient before the first prescription could be considered a key component in preventing long-term prescriptions of BZDs [22,25]. In addition, a patient who develops dependence may pose a significant challenge to a GP [22,23,26,27]. GPs can use various strategies to gradually taper BZD use in long-term users [28–34].

To change the BZD prescribing behaviors of health professionals and taper BZD use by long-term users, it is important to reduce the risk of dependence and related adverse events from BZD use. The most common deprescribing interventions include the identifying appropriate patients for deprescribing, providing education and development training to the GPs and patients, and using tailored stepped dose reduction of BZDs [35,36]. The most common implementation strategies are targeting professional behavioral changes by using printed educational materials, educational meetings, educational outreach, local opinion leaders, audit and feedback, computerized reminders, and tailored interventions [37–40]. Audit and feedback and educational meetings are widely used in clinical practice as quality improvement measures. Two systematic reviews that examined 220 randomized controlled trials showed these had a small to moderate effect on changing the behaviors of health professionals. However, there was wide variation in their impact and the extent to which they were implemented [40,41].

Some authors suggest that blending of the effectiveness and implementation stages during development of an intervention could improve the translation of the research findings into clinical practice [42,43].

The BENZORED Phase IV trial is a hybrid type 1 effectiveness and implementation study that evaluates the effectiveness and the implementation of an intervention using a GP training workshop on the appropriate use of BZDs. The intervention encourages GPs to gradually taper BZDs for long-term users and provides monthly feedback to GPs about their BZD prescriptions and access to a support web page. This study also aims to identify barriers and facilitators that affect the implementation of this intervention in primary care settings. In the present manuscript, we report the results of the effectiveness outcomes.

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[1] Url: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003983

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