Benzodiazepine Dependence, Benzodiazepine Dependent, Benzodiazepine Withdrawal
Conditions
Keywords
benzodiazepines, blended care
Brief summary
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.
Interventions
BEHAVIORALBlended care
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.
BEHAVIORALUsual care
General practitioners offering usual care 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 both available in French and Dutch.
Sponsors
Belgium Health Care Knowledge Centre
Universiteit Antwerpen
University Ghent
Vrije Universiteit Brussel
Université Libre de Bruxelles
Université de Liège
Kristien Coteur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 and older capable of giving informed consent, * Having his/her Global Medical File managed by one of the participating general practitioners * Receiving prescriptions of (z-)BZDs from participating GP for use on a daily basis * Reporting daily intake (≥ 80% of days) of (z-)BZDs in the last 6 months for a primary indication of sleeping problems
Exclusion criteria
* Presence of any severe psychiatric and neurologic condition that in the judgment of the treating GP implies a contraindication for (z-)BZD withdrawal * Presence of terminal illness * Any cases where stopping of (z-)BZDs might be harmful * Unwillingness or inability to provide informed consent * Not having e-literacy (being familiar with email and internet use) * Patients with a substance use disorder (other than (z-)BZD) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)BZD dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening | 12 months | Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening | 6 months | Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD |
| EQ-5D-3L assessed at week 6, 12, 26 and 52 | 12 months | Effect of a blended care approach versus usual care on the quality of life. The EQ-5D-3L is the three-level version of the EuroQol five dimension scale measuring quality of life. |
| Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52 | 12 months | Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use |
| The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52 | 12 months | Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed |
Countries
Belgium
Outcome results
None listed