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Electronic Deprescribing Tool for the Prevention of PIP

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ClinicalTrials.gov Identifier: NCT03192514
Recruitment Status : Unknown
Verified June 2017 by Luís Miguel André Monteiro, University of Beira Interior.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Luís Miguel André Monteiro, 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.

Condition or disease Intervention/treatment Phase
Prevention Benzodiazepine Dependence Other: Electronic Deprescribing tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Randomization
Primary Purpose: Prevention
Official Title: Electronic Deprescribing Tool for the Prevention of Potentially Inappropriate Prescribing for Older Patients: A Protocol for a Cluster Randomized Trial
Estimated Study Start Date : October 2, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

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



Primary Outcome Measures :
  1. Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 3 months [ Time Frame: 3 months ]
    The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation

  2. Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 6 months [ Time Frame: 6 months ]
    The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation

  3. Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 12 months [ Time Frame: 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 :
  1. Health-related quality of life of patients [ Time Frame: At baseline, 3 months, 6 months, 12 months ]
    EQ-5D is a self-report questionnaire for measuring health-related quality of life

  2. number of falls of patients [ Time Frame: At baseline, 3 months, 6 months, 12 months ]
    Number of falls

  3. motor vehicle crashes of patients [ Time Frame: At baseline, 3 months, 6 months, 12 months ]
    Accidents recorded

  4. Adverse drug withdrawal effects [ Time Frame: At baseline, 3 months, 6 months, 12 months ]
    Any clinical effect

  5. GPs level satisfaction regarding deprescribing [ Time Frame: At baseline, 12 months ]
    Questionnaire with multiple choice, and open text format questions

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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192514


Contacts
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Contact: Luis Monteiro, MD 275 329 002 d1012@ubi.pt

Sponsors and Collaborators
University of Beira Interior

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Responsible Party: Luís Miguel André Monteiro, PhD Candidate at University of Beira Interior; Family Doctor, University of Beira Interior
ClinicalTrials.gov Identifier: NCT03192514     History of Changes
Other Study ID Numbers: 31/17
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luís Miguel André Monteiro, University of Beira Interior:
Polypharmacy
Benzodiazepine use