Personalized Pharmacotherapy Using Pharmacogenetics in Veterans

Официальное название

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health

Обзор

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.

Вмешательства

• Генная терапия Pharmacogenetics Testing
  Genetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment.

Первичные конечные точки

• PHQ-9 - Patient Health Questionnaire 9 [Срок оценки: 5 minutes]
• GAD-7 - General Anxiety Disorder-7 [Срок оценки: 5 minutes]
• PCL-5 - Posttraumatic Stress Disorder Checklist - 5 [Срок оценки: 5 minutes]
• OQ-45 - Outcome Questionnaire 45 [Срок оценки: 10 minutes]
• Pharmacological Side Effect Measure [Срок оценки: 10 minutes]
• Electronic Medical Record Extraction Measure [Срок оценки: 10 minutes]

Критерии участия

Критерии включения

• Provider participant:

• Are at least 18 years of age;
• Speak and write English;
• 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.
• 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).

Критерии исключения

• Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• MacDonald Franklin OSI Research and Innovation Centre — London

Идентификаторы

NCT: NCT06335043 · 119245

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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