DementiaOptimaMedLTCNCT05155748
Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders
A study testing Continuous education and knowledge exchange in people with Dementia, run by Dre Edeltraut Kröger at 1 site in Canada.
Trial summary
Canadians with neurocognitive disorders often are admitted to nursing homes when their disease reaches an advanced stage. At the end of their life, they may encounter adverse symptoms related to medications they no longer need, while they should receive comfort care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Continuous education and knowledge exchange
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 6 Dec 2016to 1 Feb 2019
- 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
- Clinical diagnosis of Major neurocognitive disorders, OR severe dementia (stage 7 on the Reisberg Functional Assessment Staging Tool) of any type;
- Able to swallow
- Having prescribed medication
Who cannot join
- Has been at the nursing home for less than 2 months at the time of enrollment.
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: Deprescribing Inappropriate Medication in Residents Suffering From Severe Dementia: OptimaMed Long Term Care, a Demonstration Project
Canadians with neurocognitive disorders often are admitted to nursing homes when their disease reaches an advanced stage. At the end of their life, they may encounter adverse symptoms related to medications they no longer need, while they should receive comfort care. This study proposes an intervention to reduce the use of inappropriate medications among residents of nursing homes with major neurocognitive disorders. For that purpose, nursing homes' nursing staff, physicians and pharmacists will receive education and tools for the review, adjustment or discontinuation of the medications that have become inappropriate for the residents. The residents' families will receive information regarding the complexity of drug treatment for elderly patients with major neurocognitive disorders and they will be kept informed about the proposed changes to their relative's medication. The intervention is expected to reduce the medication load while improving or maintaining the residents' well-being.
Read the detailed description
A quasi-experimental, cluster randomized controlled trial (CRCT) based on the results of a pilot study (). The study will take place over 6 months in 6 nursing homes (NHs) of the greater Quebec City Health Board, the Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale (CIUSSS-CN). Three NHs will be randomized to the intervention arm, three others will serve as controls, where care will be dispensed as usual. Informed consent will be sought from the representative of NH residents with major neurocognitive disorders (MNCDs).
Intervention in experimental NHs First, all members of the care teams, i.e. nursing staff, physicians and pharmacists, will receive an enriched continuous education-knowledge exchange session to inform them on the study rationale and the means of medication optimization. This session will provide tools and strategies on adjustment of certain medications (e.g. less stringent treatment goals for control of glycaemia or hypertension, alternatives to benzodiazepines). There will be an additional emphasis on tapering and discontinuation of antipsychotics. Second, the validated lists of "generally", "sometimes" or "rarely" appropriate medications for NH residents with major neurocognitive disorders (MNCDs) will be provided to the experimental NHs' staff. They will also receive algorithms on tapering of antipsychotics. The pharmacists will initiate the intervention by performing at least one medication review for each participating resident, shortly after baseline, and additional reviews if required by the participant's clinical condition. The pharmacists' medication review will result in recommendations to be discussed with nurses and the responsible physician in usual care team meetings.
Outcomes Medication regimens will be recorded over 6 months and the active medications corresponding to the lists of "generally", "sometimes" or "rarely" appropriate medications counted. At baseline and 6 months after the beginning of the intervention, participating residents will be observed for signs of discomfort (PACSLAC) and agitation (Cohen-Mansfield Agitation Inventory).
- Conditions
- Dementia
- Being tested
- Continuous education and knowledge exchange
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous education and knowledge exchangeOther
The intervention is educational and directed at the complete nursing home care team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Nursing staff, physicians and pharmacists will be invited to a continuous education - knowledge exchange session to inform them on the study rationale and the means of medication optimization.
Pharmacists will be asked to perform medication reviews, guided by the information and tools provided, for the participating residents.
Pharmacists' recommendations will be discussed during meetings with physician and nurses. Receives: Other: Continuous education and knowledge exchange |
| Control | No intervention | Care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups.
List of active medications
Measured: Change from baseline to 4-6 months after patient's inclusion into study. Less medications mean a better outcome (reduction of medication load, implying deprescribing of inappropriate medications.
Secondary outcomes (2)
Change in level of the pain, as measured by the PACSLAC-F.
This is the French version of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-F) observational scale for non verbal participating patients, between baseline and follow-up, as compared between the intervention and the control groups. The PACSLAC-F scale varies between 0 and 60 with 60 being the highest measure for the observation of pain expression. For the PACSLAC-F, lower scores mean better outcomes, signifying less pain.
PACSLAC-French version (Validité et utilité clinique d'une grille d'observation (PACSLAC-F), pour évaluer la douleur chez des aînés atteints de démence vivant en milieu de soins de longue durée (1 to 60). Aubin M, Verreault R et al, Can J Aging, #1, Spring 2008
Measured: Change from baseline to six months after patient's inclusion into study.
Change in level of agitation of participating patients between baseline and follow-up, as compared between the intervention and the control groups.
Cohen-Mansfield Agitation Inventory (CMAI) observational scale, range from 0 to 203. Lower scores mean better outcomes, signifying less discomfort.
Cohen-Mansfield, J., Marx, M. S., \& Rosenthal, A. S. (1989). A description of agitation in a nursing home. Journal of Gerontology: Medical Sciences, 44(3), M77-M84.
Measured: Change from baseline to six months after patient's inclusion into study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start6 Dec 2016
- Primary completion31 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dre Edeltraut Kröger
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Responsible party
- Sponsor-investigator, Dre Edeltraut Kröger, CHU de Quebec-Universite Laval
- Investigators
- Edeltraut Kröger, Ph.D., Principal investigator, CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155748
- Sponsor's protocol ID
- OptimaMed-2
- Acronym
- OptimaMedLTC
- Status last verified
- Nov 2021
- First submitted
- 21 Dec 2018
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant dat can be made available to other researchers upon personal request.
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 25979776Wilchesky M, Mueller G, Morin M, Marcotte M, Voyer P, Aubin M, Carmichael PH, Champoux N, Monette J, Giguere A, Durand P, Verreault R, Arcand M, Kroger E. The OptimaMed intervention to reduce inappropriate medications in nursing home residents with severe dementia: results from a quasi-experimental feasibility pilot study. BMC Geriatr. 2018 Sep 4;18(1):204. doi: 10.1186/s12877-018-0895-z.
PubMed 30180821Kroger E, Wilchesky M, Morin M, Carmichael PH, Marcotte M, Misson L, Plante J, Voyer P, Durand P. The OptimaMed intervention to reduce medication burden in nursing home residents with severe dementia: results from a pragmatic, controlled study. BMC Geriatr. 2023 Aug 28;23(1):520. doi: 10.1186/s12877-023-04222-4.
PubMed 37641020
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing Inappropriate Medication in Residents Suffering From Severe Dementia: OptimaMed Long Term Care, a Demonstration Project
- ClinicalTrials.gov ID
- NCT05155748
- Acronym / sponsor ID
- OptimaMedLTC / OptimaMed-2
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dre Edeltraut KrögerUniversity, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 14 Dec 2021 (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.
Canadians with neurocognitive disorders often are admitted to nursing homes when their disease reaches an advanced stage. At the end of their life, they may encounter adverse symptoms related to medications they no longer need, while they should receive comfort care. This study proposes an intervention to reduce the use of inappropriate medications among residents of nursing homes with major neurocognitive disorders. For that purpose, nursing homes' nursing staff, physicians and pharmacists will receive education and tools for the review, adjustment or discontinuation of the medications that have become inappropriate for the residents. The residents' families will receive information regarding the complexity of drug treatment for elderly patients with major neurocognitive disorders and they will be kept informed about the proposed changes to their relative's medication. The intervention is expected to reduce the medication load while improving or maintaining the residents' well-being.
Detailed description
A quasi-experimental, cluster randomized controlled trial (CRCT) based on the results of a pilot study (). The study will take place over 6 months in 6 nursing homes (NHs) of the greater Quebec City Health Board, the Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale (CIUSSS-CN). Three NHs will be randomized to the intervention arm, three others will serve as controls, where care will be dispensed as usual. Informed consent will be sought from the representative of NH residents with major neurocognitive disorders (MNCDs).
Intervention in experimental NHs First, all members of the care teams, i.e. nursing staff, physicians and pharmacists, will receive an enriched continuous education-knowledge exchange session to inform them on the study rationale and the means of medication optimization. This session will provide tools and strategies on adjustment of certain medications (e.g. less stringent treatment goals for control of glycaemia or hypertension, alternatives to benzodiazepines). There will be an additional emphasis on tapering and discontinuation of antipsychotics. Second, the validated lists of "generally", "sometimes" or "rarely" appropriate medications for NH residents with major neurocognitive disorders (MNCDs) will be provided to the experimental NHs' staff. They will also receive algorithms on tapering of antipsychotics. The pharmacists will initiate the intervention by performing at least one medication review for each participating resident, shortly after baseline, and additional reviews if required by the participant's clinical condition. The pharmacists' medication review will result in recommendations to be discussed with nurses and the responsible physician in usual care team meetings.
Outcomes Medication regimens will be recorded over 6 months and the active medications corresponding to the lists of "generally", "sometimes" or "rarely" appropriate medications counted. At baseline and 6 months after the beginning of the intervention, participating residents will be observed for signs of discomfort (PACSLAC) and agitation (Cohen-Mansfield Agitation Inventory).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Continuous education and knowledge exchangeNursing staff, physicians and pharmacists will be invited to a continuous education - knowledge exchange session to inform them on the study rationale and the means of medication optimization. Pharmacists will be asked to perform medication reviews, guided by the information and tools provided, for the participating residents. Pharmacists' recommendations will be discussed during meetings with physician and nurses. |
| Control | No intervention | –Care as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Major neurocognitive disorders, OR severe dementia (stage 7 on the Reisberg Functional Assessment Staging Tool) of any type;
- Able to swallow
- Having prescribed medication
Key exclusion criteria (1 listed)
- Has been at the nursing home for less than 2 months at the time of enrollment.
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 |
|---|---|---|
| Continuous education and knowledge exchangeThe intervention is educational and directed at the complete nursing home care team. | Other | Intervention |
Primary outcome
Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups.
Time frame: Change from baseline to 4-6 months after patient's inclusion into study. Less medications mean a better outcome (reduction of medication load, implying deprescribing of inappropriate medications.
List of active medications
2 secondary outcomes
Change in level of the pain, as measured by the PACSLAC-F.
Time frame: Change from baseline to six months after patient's inclusion into study.
Change in level of agitation of participating patients between baseline and follow-up, as compared between the intervention and the control groups.
Time frame: Change from baseline to six months after patient's inclusion into study.
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 14 Dec 2021.
- 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.
- Background: PubMed 30180821Wilchesky M, Mueller G, Morin M, Marcotte M, Voyer P, Aubin M, Carmichael PH, Champoux N, Monette J, Giguere A, Durand P, Verreault R, Arcand M, Kroger E. The OptimaMed intervention to reduce inappropriate medications in nursing home residents with severe dementia: results from a quasi-experimental feasibility pilot study. BMC Geriatr. 2018 Sep 4;18(1):204. doi: 10.1186/s12877-018-0895-z.
- Derived from this study: PubMed 37641020Kroger E, Wilchesky M, Morin M, Carmichael PH, Marcotte M, Misson L, Plante J, Voyer P, Durand P. The OptimaMed intervention to reduce medication burden in nursing home residents with severe dementia: results from a pragmatic, controlled study. BMC Geriatr. 2023 Aug 28;23(1):520. doi: 10.1186/s12877-023-04222-4.
- Publication of the pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant dat can be made available to other researchers upon personal request.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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
CHU de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous education and knowledge exchange in people with Dementia, run by Dre Edeltraut Kröger 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 3 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 14 Dec 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 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?
Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups. (time frame: Change from baseline to 4-6 months after patient's inclusion into study. Less medications mean a better outcome (reduction of medication load, implying deprescribing of inappropriate medications.). 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 NCT05155748, which also lists 3 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 14 Dec 2021.