Personalized Pharmacotherapy Using Pharmacogenetics in Veterans
- Conditions
- Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD
- Interventions
- Genetic: Pharmacogenetics Testing
- Registration Number
- NCT06335043
- Brief Summary
This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 155
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Provider participant:
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Are at least 18 years of age;
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Speak and write English;
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Currently working as an OSI Clinic Psychiatrist at the London St. Joseph's OSI Clinic.
- Psychiatrist with an active caseload of patients being treated for OSIs.
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Patient participant:
- Veteran (patient) CAF or RCMP member;
- Are at least 18 years of age;
- Are a current patient at the London St. Joseph's OSI Clinic;
- Current diagnosis of an OSI;
- Speak and write English;
- Consents to the use of CROMIS data for the purpose of this study; and
- Consents to the use of prior OSI Clinic data for research purposes (if you have been a patient at the OSI Clinic prior to this study, the research team will use past OSI Clinic data to observe changes over time).
- Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient with Pharmacogenetic Testing Pharmacogenetics Testing For patient participants who opt-in to pharmacogenetic testing, a report summarizing the pharmacogenetic testing results will be sent to each patient participants' respective mental health provider.
- Primary Outcome Measures
Name Time Method OQ-45 - Outcome Questionnaire 45 10 minutes A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients
GAD-7 - General Anxiety Disorder-7 5 minutes Measures severity of anxiety
Electronic Medical Record Extraction Measure 10 minutes To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms
PHQ-9 - Patient Health Questionnaire 9 5 minutes Objectifies degree of depression severity
PCL-5 - Posttraumatic Stress Disorder Checklist - 5 5 minutes A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V
Pharmacological Side Effect Measure 10 minutes To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MacDonald Franklin OSI Research and Innovation Centre
🇨🇦London, Ontario, Canada