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IntroductionProblematic benzodiazepine use is a global health issue. Although the adverse side effects of long-term use of benzodiazepines are well known, it remains difficult to implement interventions for discontinuation in primary care. Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim of this study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD) use in the long term and evaluate the implementation process.Methods and analysisThis study is a multicentre, pragmatic, cluster randomised controlled trial with 1200 patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of the general practice in a 1:1 ratio using a block randomisation system stratified per language. The study population consists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6 months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine. Secondary outcomes include discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach. The process of implementing blended care will be evaluated in a nested study.Ethics and disseminationThis trial was approved by the Ethics Committee for Research of UZ/KU Leuven (ref. S61194). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations.Trial registration numberNCT03937180.

Summary Study Objectives International guidelines recommend using benzodiazepine receptor agonists (BZRA) for maximally four weeks. Nevertheless, long-term use for chronic insomnia disorder remains a common practice. This study aimed to test the effectiveness of blended care for discontinuing long-term BZRA use in general practice. Methods A pragmatic cluster randomized controlled superiority trial compared blended care to usual care through urine toxicology screening. In the intervention, care by the general practitioner (GP) was complemented by an interactive e-learning program, based on cognitive behavioral therapy for insomnia. Adults using BZRA daily for minimally six months were eligible. Participants were clustered at the level of the GP surgery for allocation (1:1). Effectiveness was measured as the proportion of patients who had discontinued at one-year follow-up. Data analysis followed intention-to-treat principles. Results In total, 916 patients in 86 clusters, represented by 99 GPs, were randomized. Primary outcome data was obtained from 727 patients (79%). At one-year follow-up, 82 patients (18%) in blended care, compared to 91 patients (20%) in usual care, had discontinued. There was no statistically significant effect for the intervention (OR: 0·924; 95% CI: 0·60, 1·43). No adverse events were reported to the research team. Conclusions The findings did not support the superiority of blended care over usual care. Both strategies showed clinical effectiveness, with an average of 19% of patients having discontinued at one-year follow-up. Further research is important to study the effect of structurally implementing digital interventions in general practice.

Background Depression is a common mental disorder in family practice with an impact on global health. The aim of this study is to provide insight in the trends of epidemiological measures as well as pharmacological treatments and comorbidities of depression. Methods A study using data from INTEGO, a family practice registration network in Flanders, Belgium. Trends in age-standardized prevalence and incidence of depression from 2000 to 2019 as well as antidepressant prescriptions in prevalent depression cases were analyzed with join point regression. Comorbidity profiles were explored using the Cochran-Armitage test and the Jonckheere-Terpstra test. Results We identified 538 299 patients older than 15 years during the study period. We found an increasing trend in the age-standardized prevalence of depression from 6.73 % in 2000 to 9.20 % in 2019. For the incidence of depression, a decreasing trend was observed from 2000 to 2015 with an incidence of 9.42/1000 in 2000 and 6.89/1000 in 2015, followed by an increasing trend from 2015 to 2019 (incidence of 13.64/1000 in 2019). The average number of chronic diseases per patient with depression increased significantly during the study period (from 1.2 to 1.8), and the proportion of patients relative to the whole study population that received at least one antidepressant prescription per year increased between 2000 and 2019 from 26.44% to 40.16%. Conclusions The prevalence of depression increases while the incidence sharply rises, but only in recent years. Patients with depression tend to have more comorbidities, making a multi-faceted approach to these patients more important.

BackgroundContrary to most European guidelines, benzodiazepine receptor agonists (BZRA) are often used continuously at a low dosage, being the most common form of long-term use. In Belgium, BZRA use is monitored by analyzing self-report data about medication use in the last 24 h. This method provides insufficient insight into the terms of use of these psychoactive drugs.AimTo describe trends in BZRA prescribing in Flanders, Belgium, between 2000 and 2019.Design and settingPopulation-based trend analysis and a case-control study for the year 2019 were done with data from a morbidity registry in general practice.MethodsRepeated cross-sectional and joinpoint regression analyses revealed trends in sex- and age-standardized prescription rates among adult patients (18+).ResultsOverall, BZRA prescriptions increased. The highest overall increase was found among male patients 18–44 years old, with an average annual percentage change of 2.5 (95% CI: 0.9, 4.3). Among 65+ female patients, a decrease was found since 2006, with an annual percentage change of −0.7 (95% CI: −1.3, −0.1). In 2019, 12% of registered patients received minimally one prescription, long-term use was observed in 5%, back pain was the most common morbidity significantly associated with a rise in BZRA prescriptions, and zolpidem was the most prescribed BZRA (22%).ConclusionDespite some statistically significant decreasing trends, an overall increase in BZRA prescriptions was observed throughout the 19-year study period, especially among long-term users of 18–44 years and 65-plus. Zolpidem became the most prescribed BZRA and warrants more attention.

Objective This study aimed to provide recommendations for a personalized electronic informed consent interface that is adapted to research participants’ needs and could enable a longitudinal interaction between the participants and the research team. Methods The co-creation process consisted of three co-creation workshops, one focus group discussion, and four semi-structured interviews. In total, 24 participants, who had taken part in four disparate clinical studies in Belgium, were involved. Descriptive statistics and qualitative content analysis were applied to analyze the survey data and audio recordings. Results Varying perceptions on the type and amount of information described in an informed consent form were reported. Other findings were related to the structure and presentation of information, setting preferences for data sharing, and electronically signing new informed consent versions. Regarding the long-term interaction, most of the participants wanted to receive progress updates, including the results, of the study in which they had taken part. They proposed to receive a notification, preferably via email, in case new information is made available on the electronic informed consent interface. Conclusions To optimally support the design of an electronic informed consent interface, it is key to understand the research participants’ needs. Study findings suggest that an electronic informed consent interface may be a promising technological application to interactively provide study-related information and to keep participants informed during and after the clinical study.

Background Long-term use of benzodiazepine receptor agonists (BZRAs) remains common despite European guidelines advising that these drugs be used in the lowest possible dose and for the shortest possible duration. Half of all BZRAs are prescribed in family practice. This creates a window of opportunity for discontinuation in primary care. Therefore, the effectiveness of blended care for the discontinuation of long-term BZRA use in adult primary care patients with chronic insomnia disorder was tested in a multicenter, pragmatic, and cluster randomized controlled superiority trial in Belgium. In the literature, information on implementing blended care in a primary care setting is scarce. Objective The study aimed to contribute to a framework for the successful implementation of blended care in a primary care setting by increasing our understanding of this complex intervention through an evaluation of e-tool use and views and ideas of participants in a BZRA discontinuation trial. Methods Based on a theoretical framework, this study evaluated the processes of recruitment, delivery, and response using 4 components: a survey on recruitment (n=76), semistructured in-depth interviews with patients (n=18), web-based asynchronous focus groups with general practitioners (GPs; n=19), and usage data of the web-based tool. Quantitative data were analyzed descriptively, and qualitative data were analyzed thematically. Results For recruitment, the most common barriers were refusal by the patient and the lack of digital literacy, while facilitators were starting the conversation and the curiosity of patients. The delivery of the intervention to the patients was diverse, ranging from GPs who never informed the patient about their access to the e-tool to GPs consulting the e-tool in between consultations to have discussion points when the patient visited. Concerning response, patients’ and GPs’ narratives also showed much variety. For some GPs, daily practice changed because they received more positive reactions than expected and felt empowered to talk more often about BZRA discontinuation. Conversely, some GPs reported no changes in practice or among patients. In general, patients found follow-up by an expert to be the most important component in blended care, whereas GPs deemed the intrinsic motivation of patients to be the key element of success. An important barrier to implementation by the GP was time. Conclusions Overall, the participants who had used the e-tool were positive about its structure and content. Nevertheless, many patients desired a more tailored application with feedback from an expert and personal tapering schedules. Strict pragmatic implementation of blended care seems to only reach GPs with an interest in digitalization. Although not superior to usual care, blended care could be a complementary tool that allows tailoring the discontinuation process to the personal style of the GP and the needs of the patient. Trial Registration ClinicalTrials.gov NCT03937180; https://clinicaltrials.gov/ct2/show/NCT03937180

BACKGROUND Long-term use of benzodiazepine receptor agonists (BZRAs) remains common despite European guidelines advising that these drugs be used in the lowest possible dose and for the shortest possible duration. Half of all BZRAs are prescribed in family practice. This creates a window of opportunity for discontinuation in primary care. Therefore, the effectiveness of blended care for the discontinuation of long-term BZRA use in adult primary care patients with chronic insomnia disorder was tested in a multicenter, pragmatic, and cluster randomized controlled superiority trial in Belgium. In the literature, information on implementing blended care in a primary care setting is scarce. OBJECTIVE The study aimed to contribute to a framework for the successful implementation of blended care in a primary care setting by increasing our understanding of this complex intervention through an evaluation of e-tool use and views and ideas of participants in a BZRA discontinuation trial. METHODS Based on a theoretical framework, this study evaluated the processes of recruitment, delivery, and response using 4 components: a survey on recruitment (n=76), semistructured in-depth interviews with patients (n=18), web-based asynchronous focus groups with general practitioners (GPs; n=19), and usage data of the web-based tool. Quantitative data were analyzed descriptively, and qualitative data were analyzed thematically. RESULTS For recruitment, the most common barriers were refusal by the patient and the lack of digital literacy, while facilitators were starting the conversation and the curiosity of patients. The delivery of the intervention to the patients was diverse, ranging from GPs who never informed the patient about their access to the e-tool to GPs consulting the e-tool in between consultations to have discussion points when the patient visited. Concerning response, patients’ and GPs’ narratives also showed much variety. For some GPs, daily practice changed because they received more positive reactions than expected and felt empowered to talk more often about BZRA discontinuation. Conversely, some GPs reported no changes in practice or among patients. In general, patients found follow-up by an expert to be the most important component in blended care, whereas GPs deemed the intrinsic motivation of patients to be the key element of success. An important barrier to implementation by the GP was time. CONCLUSIONS Overall, the participants who had used the e-tool were positive about its structure and content. Nevertheless, many patients desired a more tailored application with feedback from an expert and personal tapering schedules. Strict pragmatic implementation of blended care seems to only reach GPs with an interest in digitalization. Although not superior to usual care, blended care could be a complementary tool that allows tailoring the discontinuation process to the personal style of the GP and the needs of the patient. CLINICALTRIAL ClinicalTrials.gov NCT03937180; https://clinicaltrials.gov/ct2/show/NCT03937180