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Clinical Trials/NCT05155748
NCT05155748
Completed
Not Applicable

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

Dre Edeltraut Kröger1 site in 1 country100 target enrollmentDecember 6, 2016
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Dre Edeltraut Kröger
Enrollment
100
Locations
1
Primary Endpoint
Change in Medication regimens between study beginning and follow-up, a compared between the intervention and the control groups.
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 6, 2016
End Date
February 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dre Edeltraut Kröger
Responsible Party
Sponsor Investigator
Principal Investigator

Dre Edeltraut Kröger

adjunct professor

CHU de Quebec-Universite Laval

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.

Outcomes

Primary Outcomes

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

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.

List of active medications

Secondary Outcomes

  • 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 Sites (1)

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