Electronic Deprescribing Tool for the Prevention of PIP

NCT03192514 — Not applicable, Terminated, 280 participants, University of Beira Interior

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

Registry	NCT03192514
Status	Terminated - Recruiting of family doctors below our goal
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	280 (Actual)
Sponsor	University of Beira Interior (Other)
Conditions	Prevention, Benzodiazepine Dependence
Interventions	Electronic Deprescribing tool (Other)
Dates	start 2017-10-02, primary completion 2018-10-31, completion 2018-12-31, first posted 2017-06-20, last updated 2021-04-30
Locations	1 site in Portugal

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Electronic Deprescribing tool	Experimental	Other: Electronic Deprescribing tool	GPs of enrolled patients with access to the electronic Deprescribing tool
Usual Care	No intervention		Usual care By GP´s

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

+Outcome measures

Primary outcomes

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 outcomes

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
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
Patients Beliefs about Medicines [At baseline, 3 months, 6 months, 12 months]: Beliefs about Medicines Questionnaire (BMQ)

+Eligibility

Sex: All, ages: 65 Years to any

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

+Locations (1)

Facility	City	Country	Status
Luís Monteiro	Aveiro	Portugal