Blended Care for the Discontinuation of Benzodiazepine Use (Big Bird)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03937180|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Benzodiazepine Dependence Benzodiazepine Dependent Benzodiazepine Withdrawal||Behavioral: Blended care Behavioral: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||924 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||cluster randomized controlled trial|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||May 2021|
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
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.
Experimental: Blended care
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
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.
- Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening [ Time Frame: 12 months ]Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
- Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937180