Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders

NCT05155748 | Completed

• 1 other identifier: OptimaMed-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups.

  List of active medications

  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.

  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.

  Change from baseline to six months after patient's inclusion into study.

Study Arms (2)

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.

Other: Continuous education and knowledge exchange

Control

NO INTERVENTION

Care as usual.

Interventions

Continuous education and knowledge exchange OTHER

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dre Edeltraut Kröger: lead
• Alzheimer Society of Canada: collaborator

Study Sites (1)

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

Québec, Canada

Location

Related Publications (3)

• 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.

  PMID: 25979776 BACKGROUND

• 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.

  PMID: 30180821 BACKGROUND

• 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.

  PMID: 37641020 DERIVED

Related Links

• Publication of the pilot study

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Edeltraut Kröger, Ph.D.

  CHU de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: adjunct professor

Model Details: cluster randomized trial

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 14, 2021
• Study Start: December 6, 2016
• Primary Completion: January 31, 2019
• Study Completion: February 1, 2019
• Last Updated: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)