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The effectiveness of a blended care program for the discontinuation of benzodiazepines use for sleeping problems in primary care: a clustered randomized trial.
Introduction Problematic benzodiazepine use is a global health issue. Although the adverse side effects of longtermuse of benzodiazepines are well known, it remains difficult to implement interventions for discontinuationin primary care. Considering the success of blended care for the treatment of sleeping disorders and thesupport of substance use disorders, evidence suggests that a blended care approach, combining face-to-faceconsultations with the general practitioner with web-based self-learning by the patient, is beneficial for thediscontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim ofthis study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zdrugs((z-)BZD) use in the long term and evaluate the implementation process.Methods and analysis This study is a multicenter, pragmatic, cluster randomized controlled trial with 1200patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of thegeneral practice in a 1:1 ratio using a block randomization system stratified per language. The study populationconsists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for atleast six months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12months 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 becollected using a study-specific online platform and analyzed using the intention-to-treat approach. Theprocess of implementing blended care will be evaluated in a nested study.
Date:3 Apr 2019 → 31 Dec 2021
Keywords:RANDOMIZED CONTROLLED TRIAL (RCT)
Disciplines:Behavioural sciences, Other clinical sciences not elsewhere classified, Social medical sciences not elsewhere classified
Project type:Collaboration project