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.
Summary of results |
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This project measured whether blended care (having access to an online platform with information, advice and support in addition to the face-to-face treatment provided by the family doctor) is more effective than usual care, i.e. standard treatment (only face-to-face treatment provided by the family doctor), for discontinuing long-term use of sleep medication (benzodiazepines or z-drugs) in primary care. Blended care differed from usual care by offering general practitioners and patients the opportunity to work with an interactive e-learning program. This program was based on cognitive behavioral therapy for insomnia (CBTi), which is a psychotherapeutic approach to treating insomnia. The study compared blended and usual care in a real-world setting, being in the general practitioners’ surgery. General practitioners, and via them their patients, were placed in one of two groups, resulting in having access or not to the interactive e-learning program. Treatment success was determined by the number of patients having stopped their sleep medication use at one year after the start of their discontinuation treatment. Patients using sleep medication for at least six months on a daily basis could enter the study. Between May 23 and December 20, 2019, 1814 individuals were screened for participation, of which 50% qualified and were willing to participate. 99 GPs were assigned by chance to provide one of the two treatments to all of their patients, which globally represented the 916 patients included. Whether patients managed to stop taking their sleep medication was assessed by asking the patients and general practitioners, and by testing if these drugs were present in a urine sample provided by the patient. Patients were followed for one year, during which three urine samples were collected. Urine sample results from the sample at 1 year were obtained from 727 individuals (79%). In both groups, some patients stopped taking their sleep medication. Almost 1 in 5 (19%) of people in the study stopped taking sleep medication after one year (18% in the e-learning program group and 20% in the routine care group). Having access to the interactive e-learning program did not mean that more individuals stopped taking their sleeping medication than in the group with only routine care from their GP. Interviews showed that motivation, but also advice and follow-up by the doctor were important for stopping sleep medication. More details about the study can be found in the clinical report, via the link to the right, once the study has been published. Or in the publication, also available via the link to the right. People who participated in the study will receive a summary of the results directly from their family doctor. |
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) |
Sponsor |
UZ Leuven |
Chief Investigator |
Prof. Dr. Catharina Matheï Academic Centre for General Practice, KU Leuven |
Trial coordinator |
Kristien Coteur |
Participating investigators |
120 GPs |
Protocol | View protocol BMJ Open |
Results | Download report View publication Sleep |
For timelines and recruitment, see dashboard
Investigator-led workstream 2017