ANZCTR - Registration

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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

Scientific title

Feasibility and clinical utility of implementation of pharmacogenomic testing in aged care

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Polypharmacy

Medication related harm

Inappropriate medication prescribing

Condition category

Condition code

Public Health

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]

Prevention

Comparator / control treatment

Standard care (patients that did not undergo pharmacogenomic testing)

Control group

Active

Outcomes

Primary outcome [1]

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.

Assessment method [1]

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.

Timepoint [1]

All measures in RE-AIM will be assessed six months after the completion of the study.

Secondary outcome [1]

N/A

Timepoint [1]

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]

Other Collaborative groups

Name [1]

THE FRANK WHIDDON MASONIC HOMES OF NEW SOUTH WALES

Address [1]

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Arrotex Pharmaceuticals

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Monash University

Address [1]

Country [1]

Australia

Other collaborator category [2]

Commercial sector/Industry

Name [2]

myDNA Life

Address [2]

Country [2]

Australia

Other collaborator category [3]

Commercial sector/Industry

Name [3]

Choice Aged Care

Address [3]

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.sydney.edu.au/research/research-integrity-and-ethics.html

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/03/2024

Approval date [1]

17/06/2024

Ethics approval number [1]

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

Dr Sophie Stocker

Address

Rm S303, Building No. A15, The University of Sydney, NSW 2006

Country

Australia

Phone

+61 2 9114 4756

Fax

sophie.stocker@sydney.edu.au

Contact person for public queries

Name

Sophie Stocker

Address

Rm S303, Building No. A15, The University of Sydney, NSW 2006

Country

Australia

Phone

+61 2 9114 4756

Fax

sophie.stocker@sydney.edu.au

Contact person for scientific queries

Name

Sophie Stocker

Address

Rm S303, Building No. A15, The University of Sydney, NSW 2006

Country

Australia

Phone

+61 2 9114 4756

Fax

sophie.stocker@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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