Evaluation of a pragmatic c-RCT to discontinue (z)BZD use for insomnia in general practice

Kristien Coteur, Catharina Matheï, Sibyl Anthierens, Kris Van Den Broeck, Marc Van Nuland

Keywords: blended care; primary care; benzodiazepines; z-drugs; pragmatic; cluster randomised controlled trial; process evaluation; mixed method; framework

There is a well-known problem of overuse of sleeping pills, benzodiazepines and z-drugs ((z-)BZD), in the Belgian population. A large proportion of people use this type of medication on a daily basis. High consumption rates of (z-)BZD are problematic as they are associated with potentially serious medical complications as well as a high social cost. In Belgium, patients need a prescription from their treating physician, which is mostly their general practitioner (GP), in order to obtain (z-)BZD. Although GPs are aware of the problem of overconsumption, they often encounter difficulties in managing the decrease and stopping of (z-)BZD. 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.

Research questions:
How can we improve implementation of blended care interventions for the discontinuation of (z-)BZD use in general practice? This study aims to evaluate the effectiveness of a blended care approach for the discontinuation of (z-)BZD use in the long term (12 months) as assessed by toxicological screening, and evaluate the implementation process.

Evaluation of a multicenter, pragmatic, cluster randomized controlled trial, with a mixed method design. Data was collected through an online survey, interviews with patients, focus groups with GPs, and a usage logbook of the online intervention.

Inspired by the framework of Grant et al. (2013), we will present lessons learned from the perspective of patients, GPs, and the managing research team with regard to the processes of recruitment, delivery of the intervention, and response.

Diversity among patients and GPs requires differentiation, for which blended care is an added value. Patients highly appreciated follow-up by the GP.

Points for discussion:
Long-term use of (z-)BZD and patient education: impact? shared-decision making?

Disbelief versus fear: generation gap among GPs

Pragmatic trials in practice: pros and cons