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Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial
  1. Kristien Coteur1,
  2. Marc Van Nuland1,
  3. Marc Vanmeerbeek2,
  4. Gilles Henrard2,
  5. Sibyl Anthierens3,
  6. Kris Van den Broeck3,
  7. An De Sutter4,
  8. Hanne Creupelandt4,
  9. Dirk Devroey5,
  10. Roel Van Overmeire5,
  11. Anne-Marie Offermans6,
  12. Nadine Kacenelenbogen6,
  13. Annouschka Laenen7,
  14. Catharina Mathei1
  1. 1Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
  2. 2Department of General Practice, Université de Liège, Liege, Belgium
  3. 3Department of General Practice, University of Antwerp, Antwerpen, Belgium
  4. 4Department of Public Health and Primary Care, Ghent University, Gent, Belgium
  5. 5Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussel, Belgium
  6. 6Department of General Medicine, Université Libre de Bruxelles, Bruxelles, Belgium
  7. 7Interuniversity Institute for Biostatistics and statistical Bioinformatics, Leuven, Belgium
  1. Correspondence to Kristien Coteur; kristien.coteur{at}


Introduction Problematic 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 analysis This 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 dissemination This 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 number NCT03937180.

  • primary care
  • public health
  • sleep medicine
  • telemedicine

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  • Contributors CM and MV are responsible for the original conception of the study and obtaining funding. They also drafted the study protocol, in cooperation with SA, who developed the nested study, and AL, who provided the statistical analysis plan. All authors assisted in finalising the protocol. CM, MVN and KC obtained ethical approval. KC wrote the first draft of the manuscript based on protocol V.1.6 dd. March 2019. CM, MVN, MV, GH, SA, KVdB, ADS, HC, DD, RVO, A-MO, NK and AL contributed to further drafts. All authors read and approved the final draft.

  • Funding This work was supported by Belgian Health Care Knowledge Centre, as part of their KCE Trials program, trial number KCE-17016.

  • Disclaimer This trial consists of independent research funded by Belgian Health Care Knowledge Centre under the Clinical Trials Programme.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (B322201939666) in March 2019 (reference number: S61194).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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