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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
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Scientific title
Feasibility and clinical utility of implementation of pharmacogenomic testing in aged care
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Secondary ID [1]
312550
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polypharmacy
334436
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Medication related harm
334437
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Inappropriate medication prescribing
334725
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Condition category
Condition code
Public Health
331064
331064
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329094
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Prevention
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Comparator / control treatment
Standard care (patients that did not undergo pharmacogenomic testing)
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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The Reach, Efficacy, Adoption, Implementation and Maintenance (RE-AIM) framework will be used to assess implementation of the service:
Reach - measure the number of people out of the total residential aged care cohort who decide to enrol in pharmacogenomic testing via an audit of the study records. Provide education (in-person short presentation) on pharmacogenomics to target population to ensure they are informed prior to enrolling in the study.
Effectiveness - measure number of actionable genotypes, number of times a pharmacogenomic result impacts prescribing, number of times pharmacist makes a recommendation, number of prescribing recommendations taken up by prescribers, identifying any differences between residents who were tested compared to those who did not. Data will be collected from resident medical records.
Adoption - cost-benefit analysis and interview stakeholders in delivery to understand key barriers and facilitators to implementing the service (thematic analysis). The health economic evaluation will adhere to the CHEERS statement. The estimation of healthcare utilization costs will involve gathering data from linked Pharmaceutical Benefits Scheme and Medicare Benefits Schedule. Interviews will be semi-structured using a study-specific questionnaire and will be approximately 30 minutes. They will be conducted by a member of the research team.
Implementation - training of clinical staff to ensure intervention is delivered properly and interview stakeholders in delivery to understand key barriers and facilitators to implementing the service. Interviews will be semi-structured using a study-specific questionnaire and will be approximately 30 minutes. They will be conducted by a member of the research team.
Maintenance - Interview stakeholders to understand key barriers and facilitators to implementing the service (thematic analysis) and check six months after study completion to see whether pharmacogenomic testing is still occurring, or if pharmacists and/or prescribers have accessed the pharmacogenomic report again in the instances where concomitant medications have been altered and/or if prescribing is concordant with the recommendations. Interviews will be semi-structured using a study-specific questionnaire and will be approximately 30 minutes. They will be conducted by a member of the research team. Other data will be collected from medical records.
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Timepoint [1]
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All measures in RE-AIM will be assessed six months after the completion of the study.
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Secondary outcome [1]
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N/A
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Assessment method [1]
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N/A
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Timepoint [1]
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N/A
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Unable to provide written informed consent, or consent through an authorised representative/guardian
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
30/04/2025
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
316976
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Other Collaborative groups
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Name [1]
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THE FRANK WHIDDON MASONIC HOMES OF NEW SOUTH WALES
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Address [1]
316976
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Country [1]
316976
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Australia
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Funding source category [2]
317008
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Other Collaborative groups
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Name [2]
317008
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Arrotex Pharmaceuticals
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Address [2]
317008
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Country [2]
317008
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
319252
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None
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Name [1]
319252
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Address [1]
319252
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Country [1]
319252
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Other collaborator category [1]
283120
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University
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Name [1]
283120
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Monash University
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Address [1]
283120
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Country [1]
283120
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Australia
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Other collaborator category [2]
283130
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Commercial sector/Industry
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Name [2]
283130
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myDNA Life
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Address [2]
283130
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Country [2]
283130
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Australia
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Other collaborator category [3]
283131
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Commercial sector/Industry
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Name [3]
283131
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Choice Aged Care
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Address [3]
283131
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Country [3]
283131
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315731
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
315731
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https://www.sydney.edu.au/research/research-integrity-and-ethics.html
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Ethics committee country [1]
315731
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Australia
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Date submitted for ethics approval [1]
315731
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28/03/2024
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Approval date [1]
315731
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17/06/2024
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Ethics approval number [1]
315731
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sophie Stocker
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Address
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Rm S303, Building No. A15, The University of Sydney, NSW 2006
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Country
135630
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Australia
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Phone
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+61 2 9114 4756
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Fax
135630
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Email
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[email protected]
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Contact person for public queries
Name
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Sophie Stocker
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Address
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Rm S303, Building No. A15, The University of Sydney, NSW 2006
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Country
135631
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Australia
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Phone
135631
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+61 2 9114 4756
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Fax
135631
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Email
135631
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[email protected]
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Contact person for scientific queries
Name
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Sophie Stocker
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Address
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Rm S303, Building No. A15, The University of Sydney, NSW 2006
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Country
135632
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Australia
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Phone
135632
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+61 2 9114 4756
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Fax
135632
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Email
135632
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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