跳至主要内容
临床试验/NCT06335043
NCT06335043招募中不适用

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2024年4月25日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Don Richardson

Scientific Director

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (2)

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