ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Major Depressive Disorder

Anxiety Disorders

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Impact of Pharmacogenomics testing on treatment options informed by clinician study-specific survey

Timepoint [1]

Week 26

Secondary outcome [1]

Nil

Timepoint [1]

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?

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]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

St Vincent's Health Australia Ltd

Address [1]

St Vincent's Health Australia Ltd
Level 22, 100 William St, Woolloomooloo NSW 2011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital HREC

Ethics committee address [1]

95 - 105 Boundary St, Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/09/2019

Approval date [1]

09/10/2019

Ethics approval number [1]

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

A/Prof Kathy Wu

Address

Organisation: St Vincent’s Hospital Sydney
Department: Clinical Genomics Unit
97 to 105 Boundary Street
Darlinghurst
NSW
2010

Country

Australia

Phone

+61 0283824899

Fax

[email protected]

Contact person for public queries

Name

Kathy Wu

Address

Organisation: St Vincent’s Hospital Sydney
Department: Clinical Genomics Unit
97 to 105 Boundary Street
Darlinghurst
NSW
2010

Country

Australia

Phone

+61 0283824899

Fax

[email protected]

Contact person for scientific queries

Name

Kathy Wu

Address

Organisation: St Vincent’s Hospital Sydney
Department: Clinical Genomics Unit
97 to 105 Boundary Street
Darlinghurst
NSW
2010

Country

Australia

Phone

+61 0283824899

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10940	Study 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.

Trial Review

Documents added manually

Documents added automatically