Electronic Deprescribing Tool for the Prevention of PIP

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03192514
• Other study ID #: 31/17
• Status: Terminated
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2021
• Source: University of Beira Interior
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Benzodiazepine Dependence
• Prevention

Intervention

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

Locations

Country	Name	City	State
Portugal	Luís Monteiro	Aveiro

Sponsors (1)

Lead Sponsor	Collaborator
University of Beira Interior

Country where clinical trial is conducted

Portugal, 

Outcome

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