PreventionNCT03192514
Electronic Deprescribing Tool for the Prevention of PIP
A study testing Electronic Deprescribing tool in people with Prevention and Benzodiazepine Dependence, run by University of Beira Interior at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Prevention, Benzodiazepine Dependence
- What is being tested?
- Electronic Deprescribing tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Oct 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prevention, Benzodiazepine Dependence
- Being tested
- Electronic Deprescribing tool
- Keywords
- Polypharmacy, Benzodiazepine use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Deprescribing toolOther
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
| Study group | Role | What they receive |
|---|---|---|
| Electronic Deprescribing tool | Experimental | GPs of enrolled patients with access to the electronic Deprescribing tool Receives: Other: Electronic Deprescribing tool |
| Usual Care | No intervention | Usual care By GP´s |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 Months
Secondary outcomes (6)
Health-related quality of life of patients
EQ-5D is a self-report questionnaire for measuring health-related quality of life
Measured: At baseline, 3 months, 6 months, 12 months
number of falls of patients
Number of falls
Measured: At baseline, 3 months, 6 months, 12 months
motor vehicle crashes of patients
Accidents recorded
Measured: At baseline, 3 months, 6 months, 12 months
Adverse drug withdrawal effects
Any clinical effect
Measured: At baseline, 3 months, 6 months, 12 months
GPs level satisfaction regarding deprescribing
Questionnaire with multiple choice, and open text format questions
Measured: At baseline, 12 months
Patients Beliefs about Medicines
Beliefs about Medicines Questionnaire (BMQ)
Measured: At baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start2 Oct 2017
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Why it stopped: Recruiting of family doctors below our goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís Miguel André Monteiro, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192514
- Sponsor's protocol ID
- 31/17
- Status last verified
- Apr 2021
- First submitted
- 13 Jun 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Deprescribing Tool for the Prevention of Potentially Inappropriate Prescribing for Older Patients: A Protocol for a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03192514
- Acronym / sponsor ID
- 31/17
- Conditions
- Prevention, Benzodiazepine Dependence
- Keywords
- Polypharmacy, Benzodiazepine use
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting of family doctors below our goal
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Deprescribing tool | Experimental | Other: Electronic Deprescribing toolGPs of enrolled patients with access to the electronic Deprescribing tool |
| Usual Care | No intervention | –Usual care By GP´s |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Deprescribing toolEach 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 | Other | Electronic Deprescribing tool |
Primary outcome
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
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
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
6 secondary outcomes
Health-related quality of life of patients
Time frame: At baseline, 3 months, 6 months, 12 months
number of falls of patients
Time frame: At baseline, 3 months, 6 months, 12 months
motor vehicle crashes of patients
Time frame: At baseline, 3 months, 6 months, 12 months
Adverse drug withdrawal effects
Time frame: At baseline, 3 months, 6 months, 12 months
GPs level satisfaction regarding deprescribing
Time frame: At baseline, 12 months
Patients Beliefs about Medicines
Time frame: At baseline, 3 months, 6 months, 12 months
Results and safety
The study was stopped early (reason given: Recruiting of family doctors below our goal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Prevention
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Deprescribing tool in people with Prevention and Benzodiazepine Dependence, run by University of Beira Interior at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting of family doctors below our goal). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 3 months (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.