Electronic Deprescribing Tool for the Prevention of PIP

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

Official Title
-----------------
Electronic Deprescribing Tool for the Prevention of Potentially Inappropriate Prescribing for Older Patients: A Protocol for a Cluster Randomized Trial

Conditions
-----------------
Prevention, Benzodiazepine Dependence

Intervention / Treatment
-----------------
* Other: Electronic Deprescribing tool


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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Deprescribing tool<br>GPs of enrolled patients with access to the electronic Deprescribing tool | Other: Electronic Deprescribing tool<br>* 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<br>|
| No Intervention: Usual Care<br>Usual care By GP´s | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 3 months | The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation | 3 months | 
| Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 6 months | The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation | 6 months | 
| Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 12 months | The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life of patients | EQ-5D is a self-report questionnaire for measuring health-related quality of life | At baseline, 3 months, 6 months, 12 months | 
| number of falls of patients | Number of falls | At baseline, 3 months, 6 months, 12 months | 
| motor vehicle crashes of patients | Accidents recorded | At baseline, 3 months, 6 months, 12 months | 
| Adverse drug withdrawal effects | Any clinical effect | At baseline, 3 months, 6 months, 12 months | 
| GPs level satisfaction regarding deprescribing | Questionnaire with multiple choice, and open text format questions | At baseline, 12 months | 
| Patients Beliefs about Medicines | Beliefs about Medicines Questionnaire (BMQ) | At baseline, 3 months, 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polypharmacy, Benzodiazepine use