The effectiveness of a blended care program for the discontinuation of benzodiazepines use for sleeping problems in primary care: a clustered randomized trial (KCE-17016)

Summary (French or Dutch)

There is a well-known problem of overuse of sleeping pills (benzodiazepines) in the Belgian population and a large proportion of people taking sleeping pills are doing so on an daily basis. The high consumption of sleeping pills is problematic as it is associated with potentially serious medical complications as well as a high social cost (costs related to the use of health care services, productivity losses, premature mortality and non-financial welfare costs like loss of quality of life). In Belgium, patients need a prescription from their treating physician, which is mostly their general practitioner (GP), in order to get benzodiazepines. Although GPs are aware of the problem of overconsumption, they often encounter difficulties in managing the decrease and stopping of benzodiazepines. This study aims to compare two strategies performed by GPs to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. The first strategy consists of the usual or standard support provided by the GP, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the GP are alternated with web-based self-learning by the patient. Prior research suggested that such blended care might be superior to the usual care e.g. using a discontinuation advice or letter.

Trial Description

 

Title

The effectiveness of a blended care program for the discontinuation of benzodiazepines use for sleeping problems in primary care: a clustered randomized trial (KCE-17016)

Participants (P)

Patients in primary care with chronic benzodiazepine (BZD) use for primarily sleeping indication

Intervention (I)

An interactive e-learning programme delivered through a secured web-based platform for patients and general practitioners (GPs), blended with face-to-face contacts between the involved GP and patient. The e-tool provides psycho-education about sleep and sleeping disorders, sleeping medication and its associated risks, non-pharmacological alternatives and tapering of (z-)BZD.

Control (C)

Patients will receive ‘usual care’ left at the discretion of the treating GP. GPs are expected to follow the Belgian guidelines as described in the most recent online version of “Anxiety, stress and sleeping problems A toolbox for general practitioners.” or “Sleeping pills and sedatives. How to assist your patients in the search for other solutions?” which are available both in French and Dutch. The recommended approach proposed in this toolbox typically involves education of the patient about the harmful effects of chronic (z-)BZD use and the alternatives, and advice to discontinue (z-)BZD use.

Outcome (O)

Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening

Trial Design

Cluster randomised trial at level of GP practice

Sample Size

1182 patients

Trial duration

20 months (FPI-CSR)

Budget

€2.2 million (incl. VAT)

Start date (FPI)

Q2 2019

Status

Open

Study report expected

Q1 2021

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Prof. Dr. Catharina Matheï

Academic Centre for General Practice, KU Leuven

Trial coordinator

Kristien Coteur

Participating investigators

120 GPs
Documents
Protocol  
Report

when available

Publication

when available

References

Clinicaltrials.gov: NCT03937180

Big Bird Trial webpage 

Funding scheme

Investigator-led workstream 2017