Implementing Risk-Based Preemptive Pharmacogenomic (PGx) Testing in Employee Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change in Total Per Member Per Month (PMPM) Healthcare Costs
研究概览
简要总结
The goal of this prospective randomized clinical trial is to learn if a pharmacist-provided personalized medication review (PMR) that discusses pharmacogenomic test results will improve medication outcomes.
The primary aim is to identify patients within the Pitt/UPMC employee health programs who are most likely to benefit from PGx testing based on prescription history. The second aim is to determine the effect of the pharmacist-provided PMR including PGx test results.
Participants 18 years of age and older who have undergone PGx testing through a independent biobanking study (Pitt+Me Discovery) will be randomly assigned to receive PMR with a discussion of PGx test results or PMR without PGx results. Those who receive PMR only will receive PGx results one year after their PMR. Researchers will compare the groups to see if a pharmacist-provided PMR using PGx test results will lead to better medication outcomes and lower medical costs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>/= 18 years old
- •Enrolled in the UPMC insurance plan for at least 1 year
- •Identified by UPMC Healthplan as a Pitt/UPMC employee who is likely to benefit from preemptive PGx panel testing based on polypharmacy, high annual prescription costs and a risk for poor medication-related outcomes based on exposure to medications with FDA or CPIC Level A/B PGx guidance using payer data
- •Participating in Pitt+Me Discovery with elective return of PGx results
排除标准
- •Previous panel PGx testing (self-reported)
- •Have a terminal illness (specifically metastatic cancer, palliative care or hospice)
- •Have had a liver, small bowel, or allogenic bone marrow/stem cell transplant
- •Cannot provide informed consent and/or complete the study protocol due to serious cognitive impairment
- •Institutionalized or too ill to participate (i.e. incarcerated, psychiatric or nursing home facility)
- •Plan to drop UPMC Health Plan coverage for any reason within 12 months of enrollment
- •Recent blood transfusion may be exclusionary only if the end of recruitment is nearing and there is insufficient time to observe a minimum waiting period between date of transfusion and date of sample collection. These minimum waiting periods are determined by type of transfusion: 7 days for platelets/plasma/cryoprecipitate; 2 months for packed red blood cells (PRBCs): and 6 months for whole blood or unknown type of transfusion. Although a transfusion is unlikely to have major effects on genotype results from a saliva sample, these time windows remove this concern.
研究组 & 干预措施
Delayed Return of Pharmacogenomic Results
Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study. Participants in the delayed group with receive a pharmacist Personalized Medication Review without PGx results. The delayed group will receive results from the independent biobanking study (Pitt+Me Discovery) at 12 months after the Personalized Medication Review.
干预措施: Pharmacist Personalized Medication Review (PMR) (Other)
Immediate Return of Pharmacogenomic Results
Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study (Pitt+Me Discovery). Participants in the immediate group will receive a pharmacist Personalized Medication Review with PGx results.
干预措施: Pharmacist Personalized Medication Review (PMR) (Other)
Immediate Return of Pharmacogenomic Results
Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study (Pitt+Me Discovery). Participants in the immediate group will receive a pharmacist Personalized Medication Review with PGx results.
干预措施: Discussion of Pharmacogenomic results during the PMR (Other)
结局指标
主要结局
Change in Total Per Member Per Month (PMPM) Healthcare Costs
时间窗: From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit
Change in participant total per member/per month (PMPM) healthcare costs using healthplan claims data from 12 months prior to the pharmacist Personalized Medication Review (PMR) visit to 12 months after the PMR visit.
次要结局
- Change in frequency of CPIC/FDA guideline concordant prescribing(Baseline, 12 Months after PMR visit)
- Change in healthcare utilization(From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit.)
- Number of adverse events as assessed using the Patient-Reported Outcome Measure, Inquiry into Side-Effects (PROMISE) survey(6 Months after PMR visit)
- Change in Medication Access and Adherence Tool (MAAT) Score(Baseline, 6 Months after PMR)
- Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review(6 Months after PMR visit)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, 6 Months after PMR visit)
- Proportion of pharmacist recommendations were accepted(12 months after PMR visit)
- Frequency of Actionable Genotypes(At 12 months after PMR visit)
研究者
Philip Empey
Associate Professor
University of Pittsburgh