None listed
Conditions
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.
Interventions
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 interactio
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.
Sponsors
St Vincent's Hospital Clinical Genomics
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
Unwilling to participate in study
Outcome results
None listed