Electronic Deprescribing Tool for the Prevention of PIP

NCT03192514 | Terminated DMC

• 1 other identifier: 31/17
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention; Benzodiazepine Dependence

Keywords

Polypharmacy; Benzodiazepine use

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Health-related quality of life of patients

  At baseline, 3 months, 6 months, 12 months

• number of falls of patients

  At baseline, 3 months, 6 months, 12 months

• motor vehicle crashes of patients

  At baseline, 3 months, 6 months, 12 months

• Adverse drug withdrawal effects

  At baseline, 3 months, 6 months, 12 months

• GPs level satisfaction regarding deprescribing

  At baseline, 12 months

Study Arms (2)

Electronic Deprescribing tool

EXPERIMENTAL

GPs of enrolled patients with access to the electronic Deprescribing tool

Other: Electronic Deprescribing tool

Usual Care

NO INTERVENTION

Usual care By GP´s

Interventions

Electronic Deprescribing tool OTHER

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

Electronic Deprescribing tool

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Beira Interior: lead

Study Sites (1)

Luís Monteiro

Aveiro, 3810, Portugal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate at University of Beira Interior; Family Doctor

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 20, 2017
• Study Start: October 2, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)