Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Testing Acceptibility
研究概览
简要总结
Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Testing Acceptibility
时间窗: 3 months after after baseline.
Acceptability will be measured via a four-item patient satisfaction survey three months after the testing and a two-item clinician satisfaction survey after discharge. Responses will be recorded on a five-point Likert scale (1 = very dissatisfied to 5 = very satisfied).
Implementation Practicality
时间窗: Up to 3 Months
Practicality will be measured by the mean and median testing turnaround time (i.e., test ordering to return of results).
Implementation Feasibility
时间窗: Patient discharge date [within 3 months of baseline].
Implementation will be measured using a two-item clinician self-report questionnaire that asks about using testing results in the prescribing decision-making process. These will be Yes/No questions, with more "yes" responses indicating higher usefulness and interest in using the test in clinical practice.
Test Demands
时间窗: Patient discharge date [within 3 months of baseline].
Demand will be measured by the total number of referrals to the study and by a one-item clinician self-report questionnaire asking about intent to use the testing in the future. Responses will be recorded on a five-point Likert scale (1 = very unlikely to 5 = very likely).
次要结局
- Clinical Global Impression Scale (CGI) - Severity(Baseline)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline and 3 months after baseline.)
- Clinical Global Impression Scale (CGI) - Improvement(3 months after baseline.)
- Brief Psychiatric Rating Scale (BPRS)(Baseline and patient discharge date, within 3 months.)
- DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult(Baseline and 3 months after baseline.)
- Altman Self-Rating Mania Scale (ASRM) - Adult(Baseline and 3 months after baseline.)
- General Anxiety Disorder-7 (GAD-7)(Baseline and 3 months after baseline.)
- The Early Psychosis Screener (EPS-26)(Baseline and 3 months after baseline.)
- Frequency, Intensity, Burden of Side Effects Rating (FIBSER)(Baseline (if applicable) and 3 months after baseline.)
- Healthcare Utlization(1 year)
研究者
Abdullah Al Maruf
Assistant Professor
University of Manitoba