Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders

Dementia Clinical Trial

— OptimaMedLTC  

Official title:

Deprescribing Inappropriate Medication in Residents Suffering From Severe Dementia: OptimaMed Long Term Care, a Demonstration Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155748
• Other study ID #: OptimaMed-2
• Status: Completed
• Phase: N/A
• Start date: December 6, 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: November 2021
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Continuous education and knowledge exchange
The intervention is educational and directed at the complete nursing home care team.

Locations

Country	Name	City	State
Canada	Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale	Québec

Sponsors (2)

Lead Sponsor	Collaborator
Dre Edeltraut Kröger	Alzheimer Society of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Kröger 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. Review. — View Citation

Wilchesky M, Mueller G, Morin M, Marcotte M, Voyer P, Aubin M, Carmichael PH, Champoux N, Monette J, Giguère A, Durand P, Verreault R, Arcand M, Kröger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.

External Links

•   Publication of the pilot study