Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- OQ-45 - Outcome Questionnaire 45
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.
结局指标
主要结局
OQ-45 - Outcome Questionnaire 45
时间窗: 10 minutes
A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients
GAD-7 - General Anxiety Disorder-7
时间窗: 5 minutes
Measures severity of anxiety
Electronic Medical Record Extraction Measure
时间窗: 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
时间窗: 5 minutes
Objectifies degree of depression severity
PCL-5 - Posttraumatic Stress Disorder Checklist - 5
时间窗: 5 minutes
A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V
Pharmacological Side Effect Measure
时间窗: 10 minutes
To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications
次要结局
未报告次要终点
研究者
Don Richardson
Scientific Director
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
