Electronic Deprescribing Tool for the Prevention of PIP

N/ATerminatedNCT03192514

University of Beira Interior280 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

280

Conditions

Prevention Benzodiazepine Dependence

Interventions

Electronic Deprescribing toolOTHER

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Luís Monteiro

Aveiro, Portugal

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 Months

Secondary Outcomes

Health-related quality of life of patients

EQ-5D is a self-report questionnaire for measuring health-related quality of life

Time frame: At baseline, 3 months, 6 months, 12 months

number of falls of patients

Number of falls

Time frame: At baseline, 3 months, 6 months, 12 months

motor vehicle crashes of patients

Accidents recorded

Time frame: At baseline, 3 months, 6 months, 12 months

Adverse drug withdrawal effects

Any clinical effect

Time frame: At baseline, 3 months, 6 months, 12 months

Data from ClinicalTrials.gov

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