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Deprescribing in a Long Term Care Facility

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ClinicalTrials.gov Identifier: NCT03091153
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Eastern Health
Information provided by (Responsible Party):
Deborah Kelly, Memorial University of Newfoundland

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Polypharmacy Other: Medication Review Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Deprescribing Intervention on Nursing Home Residents: a Randomized Controlled Trial
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. All cause mortality rate [ Time Frame: 3 and 6 months after receiving the intervention ]
    Measured using patient health records

  2. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Frequency of pain [ Time Frame: 3 and 6 months after receiving the intervention ]
    Measured using the Pain Scale obtained from RAI MDS 2.0



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091153


Locations
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Canada, Newfoundland and Labrador
St Patrick`s Mercy Home
St. John`s, Newfoundland and Labrador, Canada
Sponsors and Collaborators
Memorial University of Newfoundland
Eastern Health
Investigators
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Principal Investigator: Deborah Kelly, PharmD Memorial University of Newfoundland

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Responsible Party: Deborah Kelly, Associate Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT03091153     History of Changes
Other Study ID Numbers: HREB - 2016.312
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No