Pharmacogenomics-Supported Psychotropic Prescribing Trial

Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba

Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.

Background and Rationale: Pharmacogenomic (PGx) testing utilizes genetic information as a surrogate marker of a person's ability to process and react to drugs. This information can be used to inform medication selection and dosing, reducing the number of trials needed to choose a suitable medicine. For Manitoba healthcare providers, the only access to psychiatric PGx testing is through commercial providers, costing patients $200 to $2,300. To the best of our knowledge, no study in Manitoba has previously evaluated the feasibility of PGx testing in adult patients seeking care for mental illness.

RESEARCH OBJECTIVES: We aim to investigate the feasibility and utility of implementing PGx testing in Manitoba for adult patients seeking care for mental illness.

Primary Outcome and Measures: Feasibility will be measured along four dimensions:

• Acceptability (satisfaction surveys - patient & clinician)
• Practicality (testing turnaround time)
• Implementation (clinicians' self-reported use of testing results in the prescribing decision-making process)
• Demand (number of referrals, clinicians' self-reported intent to use testing in the future)

Secondary Outcomes and Measures:

• Changes in global functioning and symptom severity [Clinical Global Impression (CGI) - Severity and Improvement; Brief Psychiatric Rating Scale (BPRS); DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure; Patient Health Questionnaire-9 (PHQ-9); General Anxiety Disorder-7 (GAD-7); Altman Self-Rating Mania Scale (ASRM); Early Psychosis Screener (EPS-26)]
• Adverse drug experience [Frequency, Intensity, Burden of Side Effects Rating (FIBSER)]
• Impact of PGx testing [Changes in medication prescribing and dispensing patterns; changes in healthcare utilization (e.g., inpatient length of stay, mental health resource use, and utilization of healthcare services)

Expected Outcomes: The findings from the proposed study will inform policymakers and facilitate decision-making and priority-setting related to implementing PGx-based psychotropic prescribing policies in Manitoba

Inclusion Criteria:

• Aged 18 years or older
• The initiation, change, dose adjustment, or augmentation of psychotropic medication(s) is indicated
• The treating clinician thinks PGx testing can benefit and refers the patient to the study

Exclusion Criteria:

• Unwillingness to donate saliva samples for genetic analysis
• History of liver or bone marrow (hematopoietic cell) transplantation
• PGx testing results are already available
• No personal health identification number (PHIN) is available