Benzodiazepine Dependence, Prevention
Conditions
Keywords
Polypharmacy, Benzodiazepine use
Brief summary
This study is a cluster randomized control trial aimed to measure the effectiveness of an educational knowledge transfer intervention to prescribers on the discontinuation of two targeted classes: Benzodiazepines andNon-benzodiazepine hypnotics.
Detailed description
The investigators intend to develop an electronic decision support tool based on the best evidence available. This electronic deprescribing tool provides the rationale on the indications of prescribing or deprescribing Benzodiazepines or/and Non-benzodiazepine hypnotics and also provides interactive tapering suggestion integrated on a calendar. It is designed to help family doctors with the goal of improving health outcomes for the elderly.
Interventions
OTHERElectronic Deprescribing tool
Each GP of the intervention group will have exclusive access to an electronic tool that will guide them on deprescribing. The innovative electronic tool created by the researchers provide the rationale on indications for prescribing or deprescribing Benzodiazepines or/and Non-benzodiazepine hypnotics and also provides an interactive tapering suggestion integrated on a calendar. The tool emphasizes that any decision to continue or discontinue a drug remains a shared decision between GP and the patient. The electronic Deprescribing tool is designed to support clinical decisions
Sponsors
University of Beira Interior
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomization
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients ≥65 years who have been taking Benzodiazepines or/and Non-benzodiazepine hypnotics for at least 3 months and who do not meet any exclusion criterion
Exclusion criteria
* incapacity or unwillingness to provide written informed consent. Patient with dementia, psychotic disorder, a severe personality disorder; institutionalization; terminal illness, seizure disorders, rapid eye movement sleep disorders, benzodiazepine withdrawal, ethanol withdrawal, severe generalized anxiety disorder, epilepsy and periprocedural anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 3 months | 3 months | The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation |
| Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 6 months | 6 months | The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation |
| Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 12 months | 12 Months | The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| motor vehicle crashes of patients | At baseline, 3 months, 6 months, 12 months | Accidents recorded |
| Patients Beliefs about Medicines | At baseline, 3 months, 6 months, 12 months | Beliefs about Medicines Questionnaire (BMQ) |
| GPs level satisfaction regarding deprescribing | At baseline, 12 months | Questionnaire with multiple choice, and open text format questions |
| Adverse drug withdrawal effects | At baseline, 3 months, 6 months, 12 months | Any clinical effect |
| Health-related quality of life of patients | At baseline, 3 months, 6 months, 12 months | EQ-5D is a self-report questionnaire for measuring health-related quality of life |
| number of falls of patients | At baseline, 3 months, 6 months, 12 months | Number of falls |
Countries
Portugal
Outcome results
None listed