- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03091153
Deprescribing in a Long Term Care Facility
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada
- St Patrick's Mercy Home
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (all of the following):
- Over 65 years of age
- Reside in St. Patrick's Mercy Home (2nd or 3rd floor units)
Exclusion Criteria (any of the following):
- 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
Study Plan
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
Collaborators
Investigators
- Principal Investigator: Deborah Kelly, PharmD, Memorial University of Newfoundland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Polypharmacy
-
University of RochesterNational Institute on Aging (NIA)Active, not recruitingPolypharmacyUnited States
-
Universitaire Ziekenhuizen KU LeuvenWithdrawn
-
Queen's University, BelfastBelfast Health and Social Care Trust; National University of Ireland, Galway... and other collaboratorsActive, not recruitingPolypharmacyIreland, United Kingdom
-
Tabula Rasa HealthCareEnrolling by invitationPolypharmacy | PharmacogenomicsUnited States
-
University of BernUniversity of Zurich; Swiss National Science Foundation; University of Basel; Utrecht...CompletedMultimorbidity | PolypharmacySwitzerland
-
Royal College of Surgeons, IrelandUniversity of Dublin, Trinity College; Health Service Executive, IrelandCompletedMultimorbidity | PolypharmacyIreland
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Recruiting
-
Northwestern UniversityUniversity of California, Los Angeles; National Institute on Aging (NIA); University... and other collaboratorsEnrolling by invitationPolypharmacyUnited States
-
Northwestern UniversityGordon and Betty Moore Foundation; ACCESS Community Health Network; Walgreen Co.CompletedPolypharmacyUnited States
Clinical Trials on Medication Review
-
Joke WuytsAssociation of Belgian Pharmacies (APB)Completed
-
Anne Estrup OlesenFrederikshavn Kommune, Frederikshavn, Denmark; Lægeklinikken Frederikshavn,...Completed
-
Psychiatric Research Unit, Region Zealand, DenmarkRegion Zealand; Steno Diabetes Center SjaellandNot yet recruitingDiabetes | Schizophrenia | Metabolic Syndrome
-
Geriatric Education and Research InstituteTan Tock Seng Hospital; Changi General HospitalCompletedMultimorbidity | Polypharmacy | Potentially Inappropriate MedicationsSingapore
-
Monash University MalaysiaCompleted
-
University of AarhusAarhus University HospitalCompleted
-
Diakonhjemmet HospitalUniversity of Oslo; Diakonhjemmet Hospital Pharmacy; Diakonhjemmet FoundationCompletedDrug-Related Side Effects and Adverse Reactions | Drug Interaction Potentiation | Medication Compliance | Remission | Medicinal Substance; Adverse EffectNorway
-
University of East AngliaRecruiting
-
Umeå UniversityCompletedCognitive ImpairmentSweden
-
Aalborg UniversityAalborg University Hospital; Danish Center for Healthcare Improvement; University...CompletedInappropriate PrescribingDenmark