PolypharmacyPhase 4NCT01148186
An Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
A Phase 4 study testing knowledge transfer tool in people with Polypharmacy and Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.
Trial summary
An educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin). Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy, Incontinence, Insomnia
- What is being tested?
- knowledge transfer tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to May 2013
- Phase
- Phase 4
- 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
- 65 year old human adults
- who fill a prescription for at least 5 medications
- community dwelling
- chronic use (3 months or longer) of at least one potentially inappropriate medication (e.g. benzodiazepine, oxybutynin)
Who cannot join
- patients with severe mental illness, dementia and epilepsy
- concomitant consumption of any other antipsychotic medication (including lithium, olanzapine, clozapine, quetiapine, risperidone, haloperidol etc.)
- concomitant consumption of any antiepileptic (including carbamazepine, valproate, gabapentin, lamotrigine, topiramate, oxcarbazepine etc.)
- concomitant consumption of a cholinesterase inhibitor or memantine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Patient as a Driver of Change: an Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
An educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).
Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults.
Read the detailed description
This study tests the effectiveness of a knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician
- Conditions
- Polypharmacy, Incontinence, Insomnia, Anxiety
- Being tested
- knowledge transfer tool
- Keywords
- Polypharmacy, Benzodiazepine use, Oxybutynin use, cognition disorders/drug therapy, incontinence
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knowledge transfer toolBehavioural
knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | Administration of an educational intervention to inform patients of the risks and safe alternatives to their current potentially inappropriate medication. The textual content of this knowledge transfer tool will be divided into three parts: a) presentation of the evidence-based risks associated with the targeted potentially inappropriate medication (e.g. benzodiazepines); b) presentation of evidence-based equally or more effective therapeutic substitutes for the medical condition (e.g. insomnia and anxiety); and c) presentation of evidence based tapering recommendations where applicable. Receives: Behavioral: knowledge transfer tool |
| Wait-list group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin)
Measured: 6 months post-intervention
Secondary outcomes (4)
Cognitive function
Montreal cognitive assessment instrument Rey's auditory verbal learning test (immediate memory, learning, and delayed recall)
Measured: 6-months post-intervention
Sleep efficiency
Sleep efficiency as documented with a sleep diary
Measured: 6-months
incontinence-related self-efficacy
incontinence-related self-efficacy as measured with the geriatric self-efficacy index
Measured: 6-months post-intervention
frequency of urinary incontinence episodes
frequency of urinary incontinence as measured with a 72-hour bladder diary
Measured: 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Study funding period reached conclusion. Sample size sufficient to complete the analysis on benzodiazepines.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Cara Tannenbaum, MD, Principal investigator, Centre de recherche de l'Institut universitaire de gériatrie de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148186
- Sponsor's protocol ID
- CIHR-2009MOP-201314-KTE
- Status last verified
- May 2013
- First submitted
- 21 Jun 2010
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin P, Tannenbaum C. A realist evaluation of patients' decisions to deprescribe in the EMPOWER trial. BMJ Open. 2017 May 4;7(4):e015959. doi: 10.1136/bmjopen-2017-015959.
PubMed 28473524Martin P, Tannenbaum C. Use of the EMPOWER brochure to deprescribe sedative-hypnotic drugs in older adults with mild cognitive impairment. BMC Geriatr. 2017 Jan 31;17(1):37. doi: 10.1186/s12877-017-0432-5.
PubMed 28143413Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.
PubMed 24733354Martin P, Tamblyn R, Ahmed S, Tannenbaum C. An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial. Trials. 2013 Mar 20;14:80. doi: 10.1186/1745-6215-14-80.
PubMed 23514019
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient as a Driver of Change: an Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
- ClinicalTrials.gov ID
- NCT01148186
- Acronym / sponsor ID
- CIHR-2009MOP-201314-KTE
- Conditions
- Polypharmacy, Incontinence, Insomnia, Anxiety
- Keywords
- Polypharmacy, Benzodiazepine use, Oxybutynin use, cognition disorders/drug therapy, incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study funding period reached conclusion. Sample size sufficient to complete the analysis on benzodiazepines.
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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.
An educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).
Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults.
Detailed description
This study tests the effectiveness of a knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Behavioral: knowledge transfer toolAdministration of an educational intervention to inform patients of the risks and safe alternatives to their current potentially inappropriate medication. The textual content of this knowledge transfer tool will be divided into three parts: a) presentation of the evidence-based risks associated with the targeted potentially inappropriate medication (e.g. benzodiazepines); b) presentation of evidence-based equally or more effective therapeutic substitutes for the medical condition (e.g. insomnia and anxiety); and c) presentation of evidence based tapering recommendations where applicable. |
| Wait-list group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 year old human adults
- who fill a prescription for at least 5 medications
- community dwelling
- chronic use (3 months or longer) of at least one potentially inappropriate medication (e.g. benzodiazepine, oxybutynin)
Key exclusion criteria (4 listed)
- patients with severe mental illness, dementia and epilepsy
- concomitant consumption of any other antipsychotic medication (including lithium, olanzapine, clozapine, quetiapine, risperidone, haloperidol etc.)
- concomitant consumption of any antiepileptic (including carbamazepine, valproate, gabapentin, lamotrigine, topiramate, oxcarbazepine etc.)
- concomitant consumption of a cholinesterase inhibitor or memantine
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 |
|---|---|---|
| knowledge transfer toolknowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician | Behavioural | Educational intervention |
Primary outcome
Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin)
Time frame: 6 months post-intervention
4 secondary outcomes
Cognitive function
Time frame: 6-months post-intervention
Sleep efficiency
Time frame: 6-months
incontinence-related self-efficacy
Time frame: 6-months post-intervention
frequency of urinary incontinence episodes
Time frame: 6-months post-intervention
Results and safety
The study was stopped early (reason given: Study funding period reached conclusion. Sample size sufficient to complete the analysis on benzodiazepines.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Derived from this study: PubMed 28473524Martin P, Tannenbaum C. A realist evaluation of patients' decisions to deprescribe in the EMPOWER trial. BMJ Open. 2017 May 4;7(4):e015959. doi: 10.1136/bmjopen-2017-015959.
- Derived from this study: PubMed 28143413Martin P, Tannenbaum C. Use of the EMPOWER brochure to deprescribe sedative-hypnotic drugs in older adults with mild cognitive impairment. BMC Geriatr. 2017 Jan 31;17(1):37. doi: 10.1186/s12877-017-0432-5.
- Derived from this study: PubMed 24733354Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.
- Derived from this study: PubMed 23514019Martin P, Tamblyn R, Ahmed S, Tannenbaum C. An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial. Trials. 2013 Mar 20;14:80. doi: 10.1186/1745-6215-14-80.
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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.
Cara Tannenbaum, MD principal investigator
Centre de recherche de l'Institut universitaire de gériatrie de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing knowledge transfer tool in people with Polypharmacy and Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.
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 4 inclusion and 4 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 15 May 2013. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study funding period reached conclusion. Sample size sufficient to complete the analysis on benzodiazepines.). 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?
Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) (time frame: 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148186, which also lists 4 linked publications.
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 15 May 2013.