Blended Care for the Discontinuation of Benzodiazepine Use

Study Overview
=================
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.

Official Title
-----------------
The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.

Conditions
-----------------
Benzodiazepine Dependence, Benzodiazepine Dependent, Benzodiazepine Withdrawal

Intervention / Treatment
-----------------
* Behavioral: Blended care
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual care<br>Patients will receive 'usual care' left at the discretion of the treating general practitioner (GP). They are expected to follow the Belgian guidelines, which propose education of the patient about the harmful effects of chronic benzodiazepines and z-drugs ((z-)BZD) use, the alternatives, and the advice to discontinue (z-)BZD use. A stepped approach is recommended. First, a minimal intervention strategy such as a discontinuation letter or a short advice is applied. If unsuccessful, a brief intervention, which may span one or more consults, is recommended. During such an intervention, the GP will - based on the principles of motivational interviewing- assess the patient's readiness for change and match the appropriate intervention. A tapering scheme will be developed which typically consists of a 10-20% reduction in the daily dose of the (z-)BZD every 2-4 weeks. | Behavioral: Usual care<br>* 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.<br>|
| Experimental: Blended care<br>Usual care is supported by the use of an interactive e-tool. The e-tool provides psycho-education about sleep and sleep medication, and exercises featuring cognitive behavioural techniques to enhance the self-management of the patient. It's purpose is to motivate patients to discontinue the use of (z-)BZD, to adapt alternative remedies and to support them in this process. The patient can grant the participating GP access to all his answers in the e-tool, making it possible to discuss their findings and experiences face-to-face. During consultations, the GP will also assess the patients' readiness for change and match the appropriate intervention. A tailored gradual taper of the (z-)BZD will be agreed upon, which typically consists of a 10-20% reduction in the daily dose every 2-4 weeks. Follow-up appointments are scheduled depending on the needs of the patient until the end of dose reduction. | Behavioral: Blended care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening | Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening | Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD | 6 months | 
| EQ-5D-3L assessed at week 6, 12, 26 and 52 | 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. | 12 months | 
| Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52 | Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use | 12 months | 
| The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52 | Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benzodiazepines, blended care