Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001073594
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
5/09/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of pharmacogenomic testing in aged care
Scientific title
Feasibility and clinical utility of implementation of pharmacogenomic testing in aged care
Secondary ID [1] 312550 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 334436 0
Medication related harm 334437 0
Inappropriate medication prescribing 334725 0
Condition category
Condition code
Public Health 331064 331064 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this project we will implement a genetic testing service in the residential aged care setting, looking specifically at genes involved in the processing of medications (i.e. pharmacogenomics). The intervention is a pharmacogenomic test using a buccal swab. The results of the pharmacogenomic test will be reviewed by the participants’ pharmacist, who upon reviewing the clinical pharmacogenomic report, will make prescribing considerations (e.g. dose adjustments or alternative medication use) to the participants’ prescriber. It is at the prescriber's discretion to follow the recommendation or not. Approximate turnaround time between the pharmacogenomic test and the prescribing considerations being delivered to the prescriber is 3-4 weeks. Changes to medication will be monitored via resident medical records and through data linkage to the Pharmaceutical Benefits Scheme.
Intervention code [1] 329094 0
Prevention
Comparator / control treatment
Standard care (patients that did not undergo pharmacogenomic testing)
Control group
Active

Outcomes
Primary outcome [1] 339043 0
Perceived feasibility and clinical utility of the pharmacogenomics service assessed using the Reach, Efficacy, Adoption, Implementation and Maintenance (RE-AIM) framework. This will be assessed as a composite outcome.
Timepoint [1] 339043 0
All measures in RE-AIM will be assessed six months after the completion of the study.
Secondary outcome [1] 438355 0
N/A
Timepoint [1] 438355 0
N/A

Eligibility
Key inclusion criteria
Current aged care resident
Proficient in the English language
Willingness to give written informed consent (or provide consent through an authorised representative/guardian for residents/Phase 1 and 2A), and willingness to participate and comply with the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to provide written informed consent, or consent through an authorised representative/guardian

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316976 0
Other Collaborative groups
Name [1] 316976 0
THE FRANK WHIDDON MASONIC HOMES OF NEW SOUTH WALES
Country [1] 316976 0
Australia
Funding source category [2] 317008 0
Other Collaborative groups
Name [2] 317008 0
Arrotex Pharmaceuticals
Country [2] 317008 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319252 0
None
Name [1] 319252 0
Address [1] 319252 0
Country [1] 319252 0
Other collaborator category [1] 283120 0
University
Name [1] 283120 0
Monash University
Address [1] 283120 0
Country [1] 283120 0
Australia
Other collaborator category [2] 283130 0
Commercial sector/Industry
Name [2] 283130 0
myDNA Life
Address [2] 283130 0
Country [2] 283130 0
Australia
Other collaborator category [3] 283131 0
Commercial sector/Industry
Name [3] 283131 0
Choice Aged Care
Address [3] 283131 0
Country [3] 283131 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315731 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315731 0
https://www.sydney.edu.au/research/research-integrity-and-ethics.html
Ethics committee country [1] 315731 0
Australia
Date submitted for ethics approval [1] 315731 0
28/03/2024
Approval date [1] 315731 0
17/06/2024
Ethics approval number [1] 315731 0

Summary
Brief summary
In this project we will implement a genetic testing service in the residential aged care setting, looking specifically at genes involved in the processing of medications (i.e. pharmacogenomics). The aim of the project is to evaluate the feasibility of implementing this service using the RE-AIM framework. DNA samples of aged care residents will be collected via cheek swabs and sent to a commercial genotyping provider (myDNA) to generate a pharmacogenomic report. The report will be sent to the resident's pharmacist who will interpret it and make a recommendation regarding the resident's medication to their prescriber. Barriers and facilitators to implementing pharmacogenomics will be identified by interviewing stakeholders including residents, clinical staff, pharmacists and prescribers. A cost-benefit analysis will be conducted comparing medication-related harm in residents the did/did not partake in pharmacogenomic testing. We expect to understand the feasibility, clinical and financial utility of implementing pharmacogenomic testing in aged care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135630 0
Dr Sophie Stocker
Address 135630 0
Rm S303, Building No. A15, The University of Sydney, NSW 2006
Country 135630 0
Australia
Phone 135630 0
+61 2 9114 4756
Fax 135630 0
Email 135630 0
[email protected]
Contact person for public queries
Name 135631 0
Sophie Stocker
Address 135631 0
Rm S303, Building No. A15, The University of Sydney, NSW 2006
Country 135631 0
Australia
Phone 135631 0
+61 2 9114 4756
Fax 135631 0
Email 135631 0
[email protected]
Contact person for scientific queries
Name 135632 0
Sophie Stocker
Address 135632 0
Rm S303, Building No. A15, The University of Sydney, NSW 2006
Country 135632 0
Australia
Phone 135632 0
+61 2 9114 4756
Fax 135632 0
Email 135632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.