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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03192514
Other study ID # 31/17
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2, 2017
Est. completion date December 31, 2018

Study information

Verified date April 2021
Source University of Beira Interior
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 280
Est. completion date December 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electronic 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

Locations

Country Name City State
Portugal Luís Monteiro Aveiro

Sponsors (1)

Lead Sponsor Collaborator
University of Beira Interior

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary number of falls of patients Number of falls At baseline, 3 months, 6 months, 12 months
Secondary motor vehicle crashes of patients Accidents recorded At baseline, 3 months, 6 months, 12 months
Secondary Adverse drug withdrawal effects Any clinical effect At baseline, 3 months, 6 months, 12 months
Secondary GPs level satisfaction regarding deprescribing Questionnaire with multiple choice, and open text format questions At baseline, 12 months
Secondary Patients Beliefs about Medicines Beliefs about Medicines Questionnaire (BMQ) At baseline, 3 months, 6 months, 12 months
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