Clinical and Economic Effectiveness of Pharmacogenomic (PGx) Testing in Patients With Polypharmacy
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
- 1
- 主要终点
- Healthcare expenditures
研究概览
简要总结
The purpose of this study is to determine the clinical and economic effectiveness of a pharmacogenomic (PGx) approach to prescribing medications in patients with high-risk polypharmacy in an integrated healthcare delivery system.
Investigators hypothesize that patients who receive the RightMed® PGx test from OneOme, LLC with subsequent counseling of their prescribers by a study pharmacist, as needed, on the appropriateness of their prescribed medications will experience lower one-year follow-up healthcare utilization and expenditures compared to control patients who receive usual care.
详细描述
The purpose of this study is to determine the clinical and economic effectiveness of a pharmacogenomic (PGx) approach to prescribing medications in patients with high-risk polypharmacy in an integrated healthcare delivery system.
Investigators hypothesize that patients who receive the RightMed® PGx test from OneOme, LLC with subsequent counseling of their prescribers by a study pharmacist, as needed, on the appropriateness of their prescribed medications will experience lower one-year follow-up healthcare utilization and expenditures compared to control patients who receive usual care.
Primary Objectives:
- Healthcare expenditures: 6- and 12-month changes in total healthcare expenditures from the Kaiser Permanente Colorado (KPCO) perspective
- Healthcare utilization: 6- and 12-month changes in hospitalizations, emergency room visits, medical office visits, and telephone encounters
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-79 years of age
- •Days supply of 5+ medications with 2+ advisable for PGx on the RightMed test
- •English or Spanish speaker
- •Current KPCO member
- •Dispensing 1 med (for advisable for PGx) in the 90 days prior with no dispensing in the previous six months -or- daily dose change (up or down) in the 90 days
- •Prescriber from Smoky Hill, Westminster, Hidden Lake, Skyline, East Denver, or Lakewood clinics
- •Available email address -
排除标准
- •Pregnant (HCG+ test in the previous 9 months)
- •A live birth in the previous 24 months
- •SNF or hospice stay in the previous 1 month
- •Hospitalization in previous 14 days
- •Diagnosis of dementia, delerium, alzheimer's, or parkinson's in the previous 6 months
- •On the KPCO No Contact List -
研究组 & 干预措施
Testing
Participants randomized to this arm will be sent a kit to collect a genetic sample from a swab of their mouths. The kit will have instructions on how to collect the genetic sample and how to send it in a postage-paid envelope to the testing laboratory (OneOme). OneOme will process the sample and The study pharmacist will scan the results and enter any related information into the participant's KPCO electronic health record. If any changes to the participant's medication(s) are recommended (for example: a dose decrease or increase, stop taking your current medication and start another), the study pharmacist will contact the participant's KPCO prescriber directly to discuss the recommendations. The prescriber may contact the participant to change the participant's medication(s).
干预措施: Pharmacogenomic test (Diagnostic Test)
Usual Care
Participants randomized to this arm will NOT be tested. They will receive usual care and the research will not involve study visits or in-person contact.
结局指标
主要结局
Healthcare expenditures
时间窗: 6 and 12 months after consent
Changes in mean/median total healthcare expenditures from the KPCO perspective
Healthcare utilization
时间窗: 6 and 12 months after consent
Changes in the proportion with at least one and mean/median count of hospitalization, emergency room visit, medical office visit, and telephone encounter
次要结局
- Medication changes(6 months after consent)
- Medication congruence(6 months after consent)
- Pharmacy expenditures(6 and 12 months after consent)
- Medication adherence(6 and 12 months after consent)