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An Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia (OptimaMed)

Primary Purpose

Dementia, Inappropriate Prescribing

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Knowledge exchange
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring quality improvement, long term care, polypharmacy

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosis of dementia of any etiology
  • severe dementia

Exclusion Criteria:

  • admission less than 2 months before intervention

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

No Intervention

Experimental

Arm Label

Pre-intervention

Post-intervention

Arm Description

Usual care

One 90-minute interdisciplinary knowledge exchange including the provision of a validated list of appropriate and inappropriate medications for severe dementia long-term care residents.

Outcomes

Primary Outcome Measures

Medication regimen
Active prescriptions

Secondary Outcome Measures

Level of pain
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC). The French version of the PACSLAC tool is a validated observational scale in use in Quebec to assess discomfort / pain. One point is added to the score for each PACSLAC item (n=60) observed over a 15-minute observation period; the sum of the four 15-minute observation periods gives the total score. The total score ranges from zero to sixty where zero represents no discomfort or pain and sixty a very high level of discomfort or pain.
Level of agitation
Cohen-Mansfield Agitation Inventory () measures level of agitation. Sum of the number of times the Cohen-Mansfield Agitation Inventory items were observed during the four 15-minute observation periods.. The total score ranges from zero to one hundred where zero represents no agitation and one hundred a very high level of agitation.

Full Information

First Posted
May 16, 2018
Last Updated
May 30, 2018
Sponsor
CHU de Quebec-Universite Laval
Collaborators
McGill University, Université de Montréal, Université de Sherbrooke, Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT03539276
Brief Title
An Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia
Acronym
OptimaMed
Official Title
The OptimaMed Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia: Results From a Quasi-experimental Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
McGill University, Université de Montréal, Université de Sherbrooke, Fonds de la Recherche en Santé du Québec

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An education intervention to promote medication reviews and interdisciplinary discussions within long-term care facilities with the aim of improving medication regimen among residents with severe dementia
Detailed Description
A quasi-experimental study in three long-term care facilities. The intervention comprises an information leaflet for families of residents, a 90-minute knowledge exchange session for general practitioners, pharmacists and nurses and a list of "generally", "sometimes", and "exceptionally" appropriate medications for severe dementia residents

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Inappropriate Prescribing
Keywords
quality improvement, long term care, polypharmacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Pre-post study
Masking
Participant
Masking Description
It was unlikely that participants could foresee whether or when their medications have been reviewed or modified.
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
One 90-minute interdisciplinary knowledge exchange including the provision of a validated list of appropriate and inappropriate medications for severe dementia long-term care residents.
Intervention Type
Behavioral
Intervention Name(s)
Knowledge exchange
Intervention Description
OptimaMed
Primary Outcome Measure Information:
Title
Medication regimen
Description
Active prescriptions
Time Frame
Four months post intervention
Secondary Outcome Measure Information:
Title
Level of pain
Description
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC). The French version of the PACSLAC tool is a validated observational scale in use in Quebec to assess discomfort / pain. One point is added to the score for each PACSLAC item (n=60) observed over a 15-minute observation period; the sum of the four 15-minute observation periods gives the total score. The total score ranges from zero to sixty where zero represents no discomfort or pain and sixty a very high level of discomfort or pain.
Time Frame
Four months post intervention
Title
Level of agitation
Description
Cohen-Mansfield Agitation Inventory () measures level of agitation. Sum of the number of times the Cohen-Mansfield Agitation Inventory items were observed during the four 15-minute observation periods.. The total score ranges from zero to one hundred where zero represents no agitation and one hundred a very high level of agitation.
Time Frame
Four months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of dementia of any etiology severe dementia Exclusion Criteria: admission less than 2 months before intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edeltraut Kröger, Ph.D.
Organizational Affiliation
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
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
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
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Learn more about this trial

An Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia

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