Electronic Deprescribing Tool for the Prevention of PIP

Electronic Deprescribing Tool for the Prevention of Potentially Inappropriate Prescribing for Older Patients: A Protocol for a Cluster Randomized Trial

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.

Study Overview

• Status: Terminated
• Conditions: Benzodiazepine Dependence; Prevention
• Intervention / Treatment: Other: Electronic Deprescribing tool

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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal, 3810
    • Luís Monteiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic Deprescribing tool; GPs of enrolled patients with access to the electronic Deprescribing tool	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
No Intervention: Usual Care; Usual care By GP´s

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Beira Interior

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Polypharmacy; Benzodiazepine use
• Other Study ID Numbers: 31/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No