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

May 30, 2018 updated by: Dre Edeltraut Kröger, CHU de Quebec-Universite Laval

The OptimaMed Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia: Results From a Quasi-experimental Intervention Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of dementia of any etiology
  • severe dementia

Exclusion Criteria:

  • admission less than 2 months before intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-intervention
Usual care
Experimental: Post-intervention
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.
Behavioral: Knowledge exchange
OptimaMed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication regimen
Time Frame: Four months post intervention
Active prescriptions
Four months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of pain
Time Frame: Four months post intervention

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.
Four months post intervention
Level of agitation
Time Frame: Four months post intervention
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.
Four months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

McGill University
Université de Sherbrooke
Université de Montréal
Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Edeltraut Kröger, Ph.D., Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OptimaMed-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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