Deprescribing in a Long Term Care Facility

July 19, 2019 updated by: Deborah Kelly, Memorial University of Newfoundland

Impact of a Deprescribing Intervention on Nursing Home Residents: a Randomized Controlled Trial

This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of the clinical pharmacy services provided in the LTC facility. For this study, eligible residents will be randomized to receive either a deprescribing focused medication review or usual care.

The deprescribing focused medication therapy assessments will be done on half of the 143 residents residing on the second and third floors of the facility. The other half of residents will serve as the control group and continue to receive their annual medication review and regular care from the attending physicians and nurses.

The deprescribing intervention will be delivered by final year pharmacy students completing their practice experiences, under the supervision of clinical pharmacists at the LTC facility and clinical pharmacists from Memorial University's Medication Therapy Services (MTS) Clinic. Currently the clinic has a well developed procedure for providing in depth medication therapy reviews for residents of the community, upon referral by their primary care physician. Students will adapt this model of medication review to have a stronger deprescribing focus and be applicable to elderly residents of a LTC facility. The intervention will consist of an in depth medication therapy review with a focus on identifying any medications that may no longer be required or are deemed to be inappropriate or potentially unsafe in the elderly based on currently guidelines/criteria. The students will work closely with members of the resident's care team on a daily basis, as well as the resident and their family, to develop and implement a deprescribing plan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

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

    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • St Patrick's Mercy Home

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 (all of the following):

  1. Over 65 years of age
  2. Reside in St. Patrick's Mercy Home (2nd or 3rd floor units)

Exclusion Criteria (any of the following):

  1. Do not take any regularly scheduled medications
  2. Are receiving palliative care
  3. Resident's physician or nursing team do not support participation
  4. Resident or their substitute decision maker decline participation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard care. Annual medication review
Experimental: Intervention
In depth medication review with a focus on deprescribing
In depth medication review with a focus on deprescribing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of medications taken daily by residents
Time Frame: 3 and 6 months after receiving intervention
Measured using facility medication logs and patient health records
3 and 6 months after receiving intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality rate
Time Frame: 3 and 6 months after receiving the intervention
Measured using patient health records
3 and 6 months after receiving the intervention
Instance of falls in the last 30 days
Time Frame: 3 and 6 months after receiving the intervention
Measured using facility fall report logs
3 and 6 months after receiving the intervention
Frequency of emergency room visits, unplanned hospital admission and/or unplanned GP visits
Time Frame: 3 and 6 months after receiving the intervention
Measured using patient health records
3 and 6 months after receiving the intervention
Cognitive function score
Time Frame: 3 and 6 months after receiving the intervention
Measured using Cognitive Performance Scale (CPS) obtained from Resident Assessment Instrument (RAI) MDS 2.0
3 and 6 months after receiving the intervention
Bowel function
Time Frame: baseline, 3 and 6 months after receiving the intervention
Measured using bowel chart data for the 14 days prior to the assessment date
baseline, 3 and 6 months after receiving the intervention
Independence in activities of daily living
Time Frame: 3 and 6 months after receiving the intervention
Measured using the Activities of Daily Living Scale (ADL) obtained from RAI MDS 2.0
3 and 6 months after receiving the intervention
Changes in general health
Time Frame: 3 and 6 months after receiving the intervention
Measured using the Changes in Health, End-Stage Disease and Signs and Symptoms (CHESS) Score obtained from RAI MDS 2.0
3 and 6 months after receiving the intervention
Social engagement
Time Frame: 3 and 6 months after receiving the intervention
Measured using Index of Social Engagement (ISE) Score obtained from RAI MDS 2.0
3 and 6 months after receiving the intervention
Aggressive behaviour
Time Frame: 3 and 6 months after receiving the intervention
Measured using the Aggressive Behaviour Scale (ABS) obtained from RAI MDS 2.0
3 and 6 months after receiving the intervention
Frequency of pain
Time Frame: 3 and 6 months after receiving the intervention
Measured using the Pain Scale obtained from RAI MDS 2.0
3 and 6 months after receiving the intervention

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Deborah Kelly, PharmD, Memorial University of Newfoundland

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 30, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HREB - 2016.312

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 drug product

No

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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