Clinical trial NCT05155748: Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders
Official title: Deprescribing Inappropriate Medication in Residents Suffering From Severe Dementia: OptimaMed Long Term Care, a Demonstration Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Alzheimer Society of Canada
First posted: 2021-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized trial
Primary purpose: PREVENTION

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Has been at the nursing home for less than 2 months at the time of enrollment.

Primary outcomes:
measure: Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups.
timeFrame: 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:
measure: Change in level of the pain, as measured by the PACSLAC-F.
timeFrame: Change from baseline to six months after patient's inclusion into study.
measure: Change in level of agitation of participating patients between baseline and follow-up, as compared between the intervention and the control groups.
timeFrame: Change from baseline to six months after patient's inclusion into study.
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
Study officials:
affiliation: CHU de Québec
name: Edeltraut Kröger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wilchesky 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.