NCT03091153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

March 21, 2017

Last Update Submit

July 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • All cause mortality rate

    3 and 6 months after receiving the intervention

  • Instance of falls in the last 30 days

    3 and 6 months after receiving the intervention

  • Frequency of emergency room visits, unplanned hospital admission and/or unplanned GP visits

    3 and 6 months after receiving the intervention

  • Cognitive function score

    3 and 6 months after receiving the intervention

  • Bowel function

    baseline, 3 and 6 months after receiving the intervention

  • +5 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Standard care. Annual medication review

Intervention

EXPERIMENTAL

In depth medication review with a focus on deprescribing

Other: Medication Review

Interventions

In depth medication review with a focus on deprescribing

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Patrick's Mercy Home

St. John's, Newfoundland and Labrador, Canada

Location

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Deborah Kelly, PharmD

    Memorial University of Newfoundland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

March 30, 2017

Primary Completion

December 31, 2018

Study Completion

June 1, 2019

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations