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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous education and knowledge exchange
Sponsored by
Dre Edeltraut Kröger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Care as usual.

Outcomes

Primary Outcome Measures

Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups.
List of active medications

Secondary Outcome Measures

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 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.

Full Information

First Posted
December 21, 2018
Last Updated
November 30, 2021
Sponsor
Dre Edeltraut Kröger
Collaborators
Alzheimer Society of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05155748
Brief Title
Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders
Acronym
OptimaMedLTC
Official Title
Deprescribing Inappropriate Medication in Residents Suffering From Severe Dementia: OptimaMed Long Term Care, a Demonstration Project
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2016 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dre Edeltraut Kröger
Collaborators
Alzheimer Society of Canada

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Care as usual.
Intervention Type
Other
Intervention Name(s)
Continuous education and knowledge exchange
Intervention Description
The intervention is educational and directed at the complete nursing home care team.
Primary Outcome Measure Information:
Title
Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups.
Description
List of active medications
Time Frame
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 Measure Information:
Title
Change in level of the pain, as measured by the PACSLAC-F.
Description
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
Time Frame
Change from baseline to six months after patient's inclusion into study.
Title
Change in level of agitation of participating patients between baseline and follow-up, as compared between the intervention and the control groups.
Description
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.
Time Frame
Change from baseline to six months after patient's inclusion into study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edeltraut Kröger, Ph.D.
Organizational Affiliation
CHU de Québec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
City
Québec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant dat can be made available to other researchers upon personal request.
Citations:
PubMed Identifier
25979776
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.
Results Reference
background
PubMed Identifier
30180821
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.
Results Reference
background
Links:
URL
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-018-0895-z
Description
Publication of the pilot study

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Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders

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