Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders (OptimaMedLTC)

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: Continuous education and knowledge exchange

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada
    • Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Continuous education and knowledge exchange; The intervention is educational and directed at the complete nursing home care team.
NO_INTERVENTION: Control; Care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Change from baseline to six months after patient's inclusion into study.

Collaborators and Investigators

• Sponsor: Dre Edeltraut Kröger
• Collaborators: Alzheimer Society of Canada
• Investigators: Principal Investigator: Edeltraut Kröger, Ph.D., CHU de Quebec

Publications and helpful links

General 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.
• 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.

Helpful Links

• Publication of the pilot study

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2016
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (ACTUAL): December 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: OptimaMed-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant dat can be made available to other researchers upon personal request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No