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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03091153
Other study ID # HREB - 2016.312
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2017
Est. completion date June 1, 2019

Study information

Verified date July 2019
Source Memorial University of Newfoundland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date June 1, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Medication Review
In depth medication review with a focus on deprescribing

Locations

Country Name City State
Canada St Patrick`s Mercy Home St. John`s Newfoundland and Labrador

Sponsors (2)

Lead Sponsor Collaborator
Memorial University of Newfoundland Eastern Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of medications taken daily by residents Measured using facility medication logs and patient health records 3 and 6 months after receiving intervention
Secondary All cause mortality rate Measured using patient health records 3 and 6 months after receiving the intervention
Secondary Instance of falls in the last 30 days Measured using facility fall report logs 3 and 6 months after receiving the intervention
Secondary Frequency of emergency room visits, unplanned hospital admission and/or unplanned GP visits Measured using patient health records 3 and 6 months after receiving the intervention
Secondary Cognitive function score Measured using Cognitive Performance Scale (CPS) obtained from Resident Assessment Instrument (RAI) MDS 2.0 3 and 6 months after receiving the intervention
Secondary Bowel function Measured using bowel chart data for the 14 days prior to the assessment date baseline, 3 and 6 months after receiving the intervention
Secondary Independence in activities of daily living Measured using the Activities of Daily Living Scale (ADL) obtained from RAI MDS 2.0 3 and 6 months after receiving the intervention
Secondary Changes in general health 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
Secondary Social engagement Measured using Index of Social Engagement (ISE) Score obtained from RAI MDS 2.0 3 and 6 months after receiving the intervention
Secondary Aggressive behaviour Measured using the Aggressive Behaviour Scale (ABS) obtained from RAI MDS 2.0 3 and 6 months after receiving the intervention
Secondary Frequency of pain Measured using the Pain Scale obtained from RAI MDS 2.0 3 and 6 months after receiving the intervention
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