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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Standard care. Annual medication review
Experimental: Intervention
In depth medication review with a focus on deprescribing
Other: Medication Review
In depth medication review with a focus on deprescribing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial University of Newfoundland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eastern Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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