Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders

NCT ID: NCT05155748

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-06
• Study Completion Date: 2019-02-01

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).

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Continuous education and knowledge exchange

Intervention Type: OTHER

The intervention is educational and directed at the complete nursing home care team.

Control

Care as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous education and knowledge exchange

The intervention is educational and directed at the complete nursing home care team.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheimer Society of Canada

OTHER

Sponsor Role: collaborator

Dre Edeltraut Kröger

OTHER

Sponsor Role: lead

Responsible Party

Dre Edeltraut Kröger

adjunct professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edeltraut Kröger, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec

Locations

Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale

Québec, , Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 25979776 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30180821 (View on PubMed)

Kroger 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.

Reference Type: DERIVED

PMID: 37641020 (View on PubMed)

Related Links

https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-018-0895-z

Publication of the pilot study

Other Identifiers

OptimaMed-2

Identifier Type: -

Identifier Source: org_study_id