DementiaOptimaMedNCT03539276
An Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia
A study testing Knowledge exchange in people with Dementia and Inappropriate Prescribing, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
An education intervention to promote medication reviews and interdisciplinary discussions within long-term care facilities with the aim of improving medication regimen among residents with severe dementia Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Inappropriate Prescribing
- What is being tested?
- Knowledge exchange
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Dec 2015
- 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
- diagnosis of dementia of any etiology
- severe dementia
Who cannot join
- admission less than 2 months before intervention
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
Québec
About this study
Official title: The OptimaMed Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia: Results From a Quasi-experimental Intervention Study
An education intervention to promote medication reviews and interdisciplinary discussions within long-term care facilities with the aim of improving medication regimen among residents with severe dementia
Read the detailed description
A quasi-experimental study in three long-term care facilities. The intervention comprises an information leaflet for families of residents, a 90-minute knowledge exchange session for general practitioners, pharmacists and nurses and a list of "generally", "sometimes", and "exceptionally" appropriate medications for severe dementia residents
- Conditions
- Dementia, Inappropriate Prescribing
- Being tested
- Knowledge exchange
- Keywords
- quality improvement, long term care, polypharmacy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge exchangeBehavioural
OptimaMed
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Usual care |
| Post-intervention | Experimental | One 90-minute interdisciplinary knowledge exchange including the provision of a validated list of appropriate and inappropriate medications for severe dementia long-term care residents. Receives: Behavioral: Knowledge exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication regimen
Active prescriptions
Measured: Four months post intervention
Secondary outcomes (2)
Level of pain
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC).
The French version of the PACSLAC tool is a validated observational scale in use in Quebec to assess discomfort / pain.
One point is added to the score for each PACSLAC item (n=60) observed over a 15-minute observation period; the sum of the four 15-minute observation periods gives the total score. The total score ranges from zero to sixty where zero represents no discomfort or pain and sixty a very high level of discomfort or pain.
Measured: Four months post intervention
Level of agitation
Cohen-Mansfield Agitation Inventory () measures level of agitation. Sum of the number of times the Cohen-Mansfield Agitation Inventory items were observed during the four 15-minute observation periods.. The total score ranges from zero to one hundred where zero represents no agitation and one hundred a very high level of agitation.
Measured: Four 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 posted29 May 2018
- Study startMar 2014
- Primary completionOct 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre-post study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Université de Montréal, Université de Sherbrooke, Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Dre Edeltraut Kröger, CHU de Quebec-Universite Laval
- Investigators
- Edeltraut Kröger, Ph.D., Principal investigator, Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539276
- Sponsor's protocol ID
- OptimaMed-1
- Acronym
- OptimaMed
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kroger E, Wilchesky M, Marcotte M, Voyer P, Morin M, Champoux N, Monette J, Aubin M, Durand PJ, Verreault R, Arcand M. Medication Use Among Nursing Home Residents With Severe Dementia: Identifying Categories of Appropriateness and Elements of a Successful Intervention. J Am Med Dir Assoc. 2015 Jul 1;16(7):629.e1-17. doi: 10.1016/j.jamda.2015.04.002. Epub 2015 May 13.
PubMed 25979776
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OptimaMed Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia: Results From a Quasi-experimental Intervention Study
- ClinicalTrials.gov ID
- NCT03539276
- Acronym / sponsor ID
- OptimaMed / OptimaMed-1
- Conditions
- Dementia, Inappropriate Prescribing
- Keywords
- quality improvement, long term care, polypharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- McGill University, Université de Montréal, Université de Sherbrooke, Fonds de la Recherche en Santé du Québec
- Study start
- Mar 2014 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 May 2018 (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.
An education intervention to promote medication reviews and interdisciplinary discussions within long-term care facilities with the aim of improving medication regimen among residents with severe dementia
Detailed description
A quasi-experimental study in three long-term care facilities. The intervention comprises an information leaflet for families of residents, a 90-minute knowledge exchange session for general practitioners, pharmacists and nurses and a list of "generally", "sometimes", and "exceptionally" appropriate medications for severe dementia residents
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pre-post study
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Usual care |
| Post-intervention | Experimental | Behavioral: Knowledge exchangeOne 90-minute interdisciplinary knowledge exchange including the provision of a validated list of appropriate and inappropriate medications for severe dementia long-term care residents. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- diagnosis of dementia of any etiology
- severe dementia
Key exclusion criteria (1 listed)
- admission less than 2 months before intervention
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 exchangeOptimaMed | Behavioural | Post-intervention |
Primary outcome
Medication regimen
Time frame: Four months post intervention
Active prescriptions
2 secondary outcomes
Level of pain
Time frame: Four months post intervention
Level of agitation
Time frame: Four months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Background: PubMed 25979776Kroger E, Wilchesky M, Marcotte M, Voyer P, Morin M, Champoux N, Monette J, Aubin M, Durand PJ, Verreault R, Arcand M. Medication Use Among Nursing Home Residents With Severe Dementia: Identifying Categories of Appropriateness and Elements of a Successful Intervention. J Am Med Dir Assoc. 2015 Jul 1;16(7):629.e1-17. doi: 10.1016/j.jamda.2015.04.002. Epub 2015 May 13.
- Individual participant dataSharing planned: No
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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.
Edeltraut Kröger, Ph.D. principal investigator
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge exchange in people with Dementia and Inappropriate Prescribing, run by CHU de Quebec-Universite Laval 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 2 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: finished, as of the sponsor's last update on 1 Jun 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication regimen (time frame: Four 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 NCT03539276, which also lists 1 linked publication.
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 1 Jun 2018.