Blended care to discontinue benzodiazepine receptor agonists use in patients with chronic insomnia disorder: a pragmatic cluster randomized controlled trial in primary care.
Kristien Coteur, Gilles Henrard, Birgitte Schoenmakers, Annouschka Laenen, Kris Van den Broeck, An De Sutter, Sibyl Anthierens, Dirk Devroey, Nadine Kacenelenbogen, Anne-Marie Offermans, Marc Van Nuland
Author Information
Kristien Coteur: Department of Public Health and Primary Care, Academic Centre for General Practice, KU Leuven, Leuven, Belgium. ORCID
Gilles Henrard: Department of General Practice, Research Unit Primary Care & Health, Liège Université, Liège, Belgium.
Birgitte Schoenmakers: Department of Public Health and Primary Care, Academic Centre for General Practice, KU Leuven, Leuven, Belgium.
Annouschka Laenen: Department of Public Health and Primary Care, Leuven Biostatistics and Statistical Bioinformatics Centre (L-Biostat), KU Leuven, Leuven, Belgium.
Kris Van den Broeck: Department of Family Medicine and Population Health, University of Antwerp, Antwerp, Belgium. ORCID
An De Sutter: Department of Public Health and Primary Care, Centre for Family Medicine, Ghent University, Ghent, Belgium.
Sibyl Anthierens: Department of Family Medicine and Population Health, University of Antwerp, Antwerp, Belgium.
Dirk Devroey: Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, Belgium.
Nadine Kacenelenbogen: Department of General Practice, Université libre de Bruxelles, Brussels, Belgium.
Anne-Marie Offermans: Department of General Practice, Université libre de Bruxelles, Brussels, Belgium.
Marc Van Nuland: Department of Public Health and Primary Care, Academic Centre for General Practice, KU Leuven, Leuven, Belgium.
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 6 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. CLINICAL TRIAL: Big Bird trial; KCE-17016. This trial is registered at clinicaltrials.gov (NCT03937180).
