Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Number of Patient Participants' With High Medication Adherence
研究概览
简要总结
This study aims to compare patient use of and satisfaction with community pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a medication therapy management (MTM) service. Pharmacist and patient outcome measures will be collected by surveys, interviews, and review of pharmacy records.
详细描述
This study aims to investigate the delivery of pharmacogenetic (PGx) testing alone or in combination with Medication Therapy Management (MTM) in the community pharmacy setting in order to assess and compare the two delivery models. Using a clust randomized trial, these effects of these two models will be compared. Pharmacist and patient outcome measures will be collected by survey, interviews, and review of pharmacy records. The investigators intend to compare the effect of PGx alone and PGx with MTM from the pharmacy perspective (to assess impact on workflow/operations) and patient perspective (to assess acceptance of testing, understanding of results, medication adherence, and overall satisfaction with delivery model). In the PGx only arm, pharmacists will offer PGx testing to patients who are prescribed one of the 10 eligible drugs (aripiprazole, carisoprodol, celecoxib, citalopram, clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin) and will return results to the patient and physician with any recommendations for drug or dosage changes based on results. In the PGx and MTM arm, pharmacists will offer PGx testing to patients prescribed one of the 10 eligible drugs and provide two MTM sessions: one at the time of testing, and one when results are returned. All patients will be surveyed before PGx testing and 3 months after receiving results. Pharmacists will be surveyed prior to their participation and following the conclusion of the study. Pharmacists will also conduct a chart review of patients and document all interactions with enrolled patients and their providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pharmacist participants must be community pharmacists licensed and practicing in North Carolina
- •Patient participants must be prescribed one of the 10 eligible medications (aripiprazole, carisoprodol, celecoxib, citalopram, clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin)
- •Patient participants must be able to consent to participating and testing on their own, and be able to read English
排除标准
- •Patients who have previously undergone pharmacogenetic testing will not be eligible.
结局指标
主要结局
Number of Patient Participants' With High Medication Adherence
时间窗: Baseline (prior to testing)
Pre-study (baseline) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Number of Patient Participants With High Medication Adherence (Post-study)
时间窗: Post-Study (after test results received)
Post-study (follow-up) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile
时间窗: Post-study (after test results received)
Patient survey question - "Did you feel your time spent with the pharmacist was worthwhile?". Reported as number of participants who selected answer choice "Yes, definitely".
Number of Patient Participants Who Recalled All Test Results
时间窗: Post-study (after test results received)
Post-Study Survey Question: "As best you can, please choose the result of your drug response test for the following genes" (Response: Result selected for all 5 genes)
Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting
时间窗: Post-study Survey (after test results received)
Post-Study Survey question: "Now that you know your test results, would you have taken the test in the first place?" (Response: 'would definitely' have taken the test)
Number of Patient Participants Who Reported Understanding of Implications of Test Results
时间窗: Post-study (after test results received)
Post\_Study Survey Question: Please indicate your level of agreement with the following statement: "I understood clearly my choices for prevention or early detection of side effects." (Response: "Sometimes/Often")
次要结局
- Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing(Post-study (3 months))
- Average Score of PGx Knowledge Assessment by Pharmacist Participants(Baseline (prior to start of study))
- Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing(Post-study (3 months))
- Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing(Post-study (3 months))