Prevention Clinical Trial
Official title:
Electronic Deprescribing Tool for the Prevention of Potentially Inappropriate Prescribing for Older Patients: A Protocol for a Cluster Randomized Trial
Verified date | April 2021 |
Source | University of Beira Interior |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Portugal | Luís Monteiro | Aveiro |
Lead Sponsor | Collaborator |
---|---|
University of Beira Interior |
Portugal,
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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---|---|---|---|
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