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.
Background Efforts to address health literacy should favour a system-based approach with the dual aim both of fostering the material conditions and creating a work culture inside health care organisations that makes it easier for people to use information. The Vienna Health Literate Organisation (V-HLO) self-assessment tool is a German-speaking questionnaire for quality managers of health care organisations. Its objective is to provide a diagnostic of the strengths and weaknesses of the organisation in terms of health literacy. Our goal was to translate and culturally adapt this questionnaire for the French-speaking part of Belgium. Methods We followed the Translation, Review, Adjudication, Pretesting, and Documentation (TRAPD) team model for cross-cultural translation of questionnaires. We used cognitive interviews with quality experts to pre-test the translation. Results Cognitive interviews allowed us to improve the translation by removing certain ambiguities, providing contextual clarifications or rephrasing some items in such a way as to render them more culturally appropriate. Local experts generally judged the tool to be relevant and applicable to their context. The insight gained with regard to their cognitive process when completing the V-HLO allowed us to identify possible barriers to the adoption of the tool (such as difficulties in considering staff literacy as a relevant target for the tool, fear of overwhelming staff, a feeling that some items fell outside the scope of health literacy and lack of attention for integration of services with primary care) and could contribute to the future development of the tool. Conclusion We translated and adapted the V-HLO self-assessment tool for French. The French version of the V-HLO will now be implemented in our local context to assess whether it can make it easier for people to deal with the complexities of health care organisations. Electronic supplementary material The online version of this article (10.1186/s12913-019-3955-y) contains supplementary material, which is available to authorized users.
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 Strengthening the capacity of hospitals to take into account the level of health literacy of their public is a necessity to improve the quality of care. One way to develop adequate health literacy responsive policy and strategies in hospitals is the use of self-assessment tools to raise awareness, help prioritise action and mobilise stakeholders. The Vienna Health Literate Organisation (V-HLO) questionnaire, recently translated and adapted into French, is designed to meet this objective. In this study we have piloted the French version of the V-HLO (V-HLO-fr) tool in the main hospitals of Liège (Belgium) to explore its feasibility and gain a first insight into the strengths and weaknesses of the health literacy responsiveness of the participating hospitals. Methods We performed explorative case studies in three hospitals. Our mode of application of the V-HLO-fr was inspired by the ‘RAND Appropriateness’ method: first, individual members of an internal multidisciplinary panel filled out the questionnaire and then the results were discussed collectively in each hospital during a ‘round table’ meeting. The feasibility of the process was assessed by direct observation of the round tables and with semi-structured phone interviews. Results The V-HLO-fr tool was fully applied in the three targeted hospitals and the process seems to be acceptable, practicable and integrable. Strengths (e.g. the facilitation of patient navigation to the hospital) and weaknesses (e.g. the provision of easy to read, understand and act on health information materials) in terms of health literacy responsiveness have been highlighted. Conclusion V-HLO-fr can be a suitable tool for a needs assessment that allows hospitals to create awareness and formulate targeted actions to further strengthen their health literacy responsiveness. Its mode of application, formalised by taking inspiration from the RAND method, could be further improved by paying more attention to recruiting and supporting participants. The V-HLO-fr and its added value in real-world projects should now be further tested in a larger number of hospitals.
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