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Trial registered on ANZCTR


Registration number
ACTRN12621000739819
Ethics application status
Approved
Date submitted
9/03/2021
Date registered
11/06/2021
Date last updated
13/05/2022
Date data sharing statement initially provided
11/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Towards implementation of pharmacogenomics-guided therapy in patients with mental illness - Stage Preliminary (P) and Stage 1 (ENACT)
Scientific title
Develop, implement and evaluate an innovative model of care to incorporate evidence based pharmacogenomic guided therapy for adult patients with mental illness: Stage Preliminary (P) and Stage 1
Secondary ID [1] 303644 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 321479 0
Anxiety Disorders 321480 0
Condition category
Condition code
Mental Health 319258 319258 0 0
Other mental health disorders
Mental Health 319259 319259 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Stage P
A retrospective audit of pharmacogenomics results of patients who underwent testing as part of their routine clinical care at the SVCG (up to 100 patients) between 1 July 2018 and 31 August 2019. The data to extracted from the retrospective audit will include: the history of medication side effects (ie: adverse drug reactions - ADR); average number of genetically incompatible medications each patient is currently taking; average number of high-risk and moderate-risk drug gene interactions as defined by the patients PG results and to review genetic/medical records to determine if implicated DGI may retrospectively explain patient’s experienced side effects or ADR.
Preliminary pilot testing of Clinician and Patient Survey with 5 clinicians and 5 lay people respectively and who represent the targeted cohort to discuss whether questions are clearly understood and will capture clinically relevant data. It is anticipated that the duration to complete the pilot survey will be 10 to 20 minutes.
Survey of GPs/clinicians (up to 100) involved in the care of patients who had PG testing as part of their routine care (Clinician Survey P). All patients from the retrospective audit and who had PG testing as part of their routine care will be approached to complete the survey, to evaluate their knowledge of PG results, as well as how the PG testing has impacted their pharmaceutical care and overall mental and physical health (Patient Survey P). It is anticipated that the duration to complete the clinician and patient survey will be 10 to 20 minutes. The link to the surveys will be sent electronically to the clinicians and patients via email.
The overall duration of Stage P is 3 to 6 months.
Outcomes from Stage P will be used to inform and refine interview/survey questions for Stage 1.
Stage 1
In order to develop a model of care (MOC) and resource needs of clinicians in regards to clinical implementation of PG testing, clinician’s knowledge, perceived utility and acceptability of this need to be evaluated.
These parameters will be evaluated firstly with the study coordinator conducting semi-structured telephone interviews, taking approximately 10 minutes, with psychiatry physicians and clinical pharmacists (Clinician Interview 1). Next, Clinician Survey 1, will be pilot tested with 5 clinicians who represent the targeted cohort to discuss whether questions are clearly understood and will capture clinically relevant data. The survey aims to capture a broader perspective from within Departments of both Psychiatry and Pharmacy (Clinician Survey 1). It is anticipated that the duration to complete the survey will be 10 to 20 minutes. The link to the surveys will be sent electronically to the clinicians via email.
The overall duration of Stage 1 is 1 to 6 months and will commence within 1 to 2 months of the completion of Stage P surveys.
The overall duration of the entire study which includes Stage P and Stage 1 is expected to be 12 months.
Intervention code [1] 320240 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327539 0
Impact of Pharmacogenomics testing on treatment options informed by clinician study-specific survey
Timepoint [1] 327539 0
Week 26
Secondary outcome [1] 396670 0
Nil
Timepoint [1] 396670 0
NA

Eligibility
Key inclusion criteria
Patient re-contact (Stage P):
• Adult patients aged 18 years or older
• Previously had PG testing arranged through SVCG or at another clinical genomic clinic
• Understands spoken and written English
• Willingness to give implied consent, and willingness to participate in and answer specific survey questions

Clinician (Stage P):
• Registered clinicians involved in the current care of the patients who had PG testing
• Willingness to give implied consent, and willingness to participate in and answer specific survey questions

Clinician (Stage 1):
• Clinicians, including specialists, registrars, residents, and clinical nurse consultants/practitioners, who are employed by the Departments of Psychiatry and Pharmacy at St Vincent’s Hospital Sydney (SVHS) or at recruited external institutions
• Willingness to give verbal consent, and willingness to participate in and answer specific interview/survey questions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to participate in study

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Sample size calculation is not applicable as both Stage P and 1 utilise a qualitative methodology. Quantitative data from surveys will be reported in descriptive terms

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/01/2021
Date of last participant enrolment
Anticipated
1/09/2021
Actual
21/02/2022
Date of last data collection
Anticipated
29/10/2021
Actual
21/02/2022
Sample size
Target
260
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18879 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 33384 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 308063 0
Charities/Societies/Foundations
Name [1] 308063 0
St Vincent's Health Australia Ltd
Country [1] 308063 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Clinical Genomics
Address
95 - 105 Boundary St, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 308793 0
None
Name [1] 308793 0
Address [1] 308793 0
Country [1] 308793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308055 0
St Vincent's Hospital HREC
Ethics committee address [1] 308055 0
95 - 105 Boundary St, Darlinghurst NSW 2010
Ethics committee country [1] 308055 0
Australia
Date submitted for ethics approval [1] 308055 0
02/09/2019
Approval date [1] 308055 0
09/10/2019
Ethics approval number [1] 308055 0
2019ETH12892

Summary
Brief summary
Background: Genetic factors play an important role in contributing to the variability in response to pharmacological agents. For example, genetic variants can affect the activity of enzymes involved in drug metabolism, either reducing or enhancing drug exposure and thus altering drug response and toxicity profiles. Despite the evidence, Australia has been slow in adopting PG testing to guide therapy. A recent Australian Parliamentary Inquiry into the Management of Healthcare Delivery in NSW, in its published report 8/56 in September 2018, expressed concerns that PG testing is not being adequately utilised in the public mental health system. It further identified PG testing as one of the key mental health priorities and made recommendations that NSW Health actively pursues and funds the increased use of PG testing as a means of improving treatment for patients with mental illness.
Primary purpose: To develop a model of care which will be informed by the attitudes and acceptability of PG, as well as the support and resource requirements, amongst potential ends users which includes clinicians and patients.
Study objectives: The primary objective of this project is to assess patient and clinician experiences, opinions and reported outcomes when utilising PG testing results, as well as barriers encountered in using PG. The secondary objective is to investigate potential impact of PG, by retrospectively auditing PG testing results, and determining the average number of major versus moderate DGI per patient, the incidence of actionable DGI (defined as one that would trigger a change in prescription), as well as the proportion of patients having at least one actionable DGI for a medication they were taking at the time of PG testing or have taken in the past. The proportion of patients whose experience of medication side effects and/or ADR may be explained by their PG results will also be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109366 0
A/Prof Kathy Wu
Address 109366 0
Organisation: St Vincent’s Hospital Sydney
Department: Clinical Genomics Unit
97 to 105 Boundary Street
Darlinghurst
NSW
2010
Country 109366 0
Australia
Phone 109366 0
+61 0283824899
Fax 109366 0
Email 109366 0
[email protected]
Contact person for public queries
Name 109367 0
Kathy Wu
Address 109367 0
Organisation: St Vincent’s Hospital Sydney
Department: Clinical Genomics Unit
97 to 105 Boundary Street
Darlinghurst
NSW
2010
Country 109367 0
Australia
Phone 109367 0
+61 0283824899
Fax 109367 0
Email 109367 0
[email protected]
Contact person for scientific queries
Name 109368 0
Kathy Wu
Address 109368 0
Organisation: St Vincent’s Hospital Sydney
Department: Clinical Genomics Unit
97 to 105 Boundary Street
Darlinghurst
NSW
2010
Country 109368 0
Australia
Phone 109368 0
+61 0283824899
Fax 109368 0
Email 109368 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10940Study protocol    381577-(Uploaded-09-03-2021-11-11-13)-Study-related document.pdf



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.