Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions (IMPT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Overall satisfaction of patient
研究概览
简要总结
In collaboration with Raffles Medical Group, we will be recruiting 500 patients and following them for the next 3-12 months to see whether pharmacogenomics information provided in the Raffles' Electronic Health Records (EHR) will be used by physicians to personalize patients' prescriptions.
详细描述
Pre-emptive genotyping provides relevant genomic data to physicians to facilitate prescribing and to facilitate checking of prescriptions by pharmacists to ensure drug safety and efficacy. This essential information should be incorporated into electronic healthcare systems and should be readily available. The effectiveness of pre-emptive genotyping to reduce adverse drug reactions (ADRs) is unknown in Singapore. Hence, this study is designed to evaluate whether it is feasible to implement large scale pre-emptive genotyping program at a hospital in Singapore and aim to integrate genomic medicine into clinical practice to improve drug safety and efficacy.
This study involves the testing of feasibility of pharmacogenomic genotyping in hospitals whereby our pharmacogenomics panel tests for 5 genes (CYP2D6, CYP2C9, CYP2C19, SLCO1B1 and HLA-B*58:01) which influences patient's response to more than 165 medications. Reports will be generated for all drugs that have been reported to be in CPIC Level A/B of association with the genes/haplotypes. The patients who are given these tests for free are recommended due to having experienced at least one of the diseases in our list or is at a risk of developing them.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who experienced at least one of the following diseases, or is at risk of developing them:
- •Diabetes Mellitus
- •Hypertension
- •Hyperlipidaemia
- •Ischaemic Heart Disease
- •Osteoarthritis
- •Rheumatoid Arthritis
- •Major Depression
排除标准
- •Below ages 21 and above ages 65
结局指标
主要结局
Overall satisfaction of patient
时间窗: 12 months
Via survey at month 12 of the study
Turnaround time of genotype result, compared to expected
时间窗: 6 months
Overall satisfaction of site principal investigators
时间窗: 6 months
Via survey done at month 6 of the study
Overall satisfaction of prescribing physicians
时间窗: 12 months
Via survey done at month 12 of the study
Prevalence of clinically actionable genotypes
时间窗: 12 months
The number of patients receiving recommendations that includes a certain follow up action which includes monitoring, change of dosing or change of prescription.
Recommendation acceptance rate
时间窗: 12 months
Defined by: (1) Number of physicians who are interested to consider pharmacogenomics information to guide prescription, measured by click-through rate of Pharmacogenomics Access Button; (2) Number of changes made to the medications post-PGx testing; (3) Data obtained from satisfaction survey for prescribing physicians
次要结局
未报告次要终点
