Electronic Deprescribing Tool for the Prevention of PIP

Not Applicable

Terminated

• Conditions: Prevention; Benzodiazepine Dependence
• Interventions: Other: Electronic Deprescribing tool

• Registration Number: NCT03192514
• Lead Sponsor: University of Beira Interior

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.

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Study Start: 2017-10-02
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 280

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic Deprescribing tool	Electronic Deprescribing tool	GPs of enrolled patients with access to the electronic Deprescribing tool

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse drug withdrawal effects	At baseline, 3 months, 6 months, 12 months	Any clinical effect
GPs level satisfaction regarding deprescribing	At baseline, 12 months	Questionnaire with multiple choice, and open text format questions
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
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)

Trial Locations

Locations (1)

Luís Monteiro; 🇵🇹 Aveiro, Portugal