Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized
研究概览
简要总结
The purpose of this study is to assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic variation that impacts the safety or efficacy of the subject medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Prescribed at least one chronic medication for mental health which is considered pharmacogenomically actionable, as defined above (amitriptyline, doxepin, imipramine, nortriptyline, citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, or venlafaxine).
- •Diagnosis of major depressive disorder (MDD)
排除标准
- •Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration
- •Persistent medication non-adherence for reasons not potentially linked to pharmacogenomic variation (e.g. inability to obtain medications due to cost; non-adherence due to cognitive impairment)
- •Individuals receiving mental health treatment/care from a non-VA facility
- •Individuals who are terminally ill
- •Inability to communicate in and/or understand English
结局指标
主要结局
Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized
时间窗: At enrollment
A medication history will be conducted at enrollment to ensure patient meets criteria for enrollment. Patients will provide a saliva sample at this timepoint. The rate of pharmacogenomic variation will be calculated based on current medications at enrollment; however, the pharmacogenomic screening panel may take up to 6 weeks to return to the patient and investigator.
次要结局
- Type of pharmacogenomic recommendations made and accepted(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Medication-related adverse events(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Patient reported reasons for non-adherence(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Rate of pharmacogenomic variation with actionable recommendations for all actionable medications(At enrollment)
- Patient reported medication adherence and reasons for non-adherence(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Mental health disease state control/progression utilizing disease state-specific validated tools(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Type of non-pharmacogenomic recommendations made and accepted(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Medication-related costs(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Number of pharmacogenomic recommendations made and accepted(3-, 6-, and 12-months post-recommendation via retrospective chart review)
- Number of non-pharmacogenomic recommendations made and accepted(3-, 6-, and 12-months post-recommendation via retrospective chart review)
研究者
Courtney Watts Alexander
Assistant Professor
Auburn University