Polypharmacy
Conditions
Keywords
Genomics
Brief summary
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.
Detailed description
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: 1. Healthcare expenditures: 6- and 12-month changes in total healthcare expenditures from the Kaiser Permanente Colorado (KPCO) perspective 2. Healthcare utilization: 6- and 12-month changes in hospitalizations, emergency room visits, medical office visits, and telephone encounters Secondary Objectives: 1. Medication changes: Counts of 6-month medication and/or dose adjustments in targeted medications 2. Medication congruence: Description of counts of RightMed test recommendations accepted by prescribers 3. Medication adherence: 6- and 12-month changes in percent of days (PDC) covered for targeted medications 4. Pharmacy expenditures: 6- and 12-month changes in outpatient prescription medication expenditures from the KPCO perspective
Interventions
DIAGNOSTIC_TESTPharmacogenomic test
The RightMed test is an end-to-end solution which includes sample collection, PGx testing services, data analysis, and clinical interpretation that helps prescribers select treatments based on evidence-driven predictions of patient drug response and tolerance. Genetic components of an individual's drug response are well established and often included on FDA medication labels. The RightMed test has incorporated existing evidence to classify the risk and likelihood of an antidepressant working for different patients. Patient results for each medication can fall into one of three categories: 1) Green - use as directed; 2) Yellow - use with caution; and 3) Red - adjust dose or choose alternative mediation.
Sponsors
OneOme, LLC
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. 18-79 years of age 2. Days supply of 5+ medications with 2+ advisable for PGx on the RightMed test 3. English or Spanish speaker 4. Current KPCO member 5. 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 6. Prescriber from Smoky Hill, Westminster, Hidden Lake, Skyline, East Denver, or Lakewood clinics 7. Available email address -
Exclusion criteria
1. Pregnant (HCG+ test in the previous 9 months) 2. A live birth in the previous 24 months 3. SNF or hospice stay in the previous 1 month 4. Hospitalization in previous 14 days 5. Diagnosis of dementia, delerium, alzheimer's, or parkinson's in the previous 6 months 6. On the KPCO No Contact List -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare expenditures | 6 and 12 months after consent | Changes in mean/median total healthcare expenditures from the KPCO perspective |
| Healthcare utilization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication changes | 6 months after consent | Mean/median counts of medication and/or dose adjustments in targeted medications |
| Medication congruence | 6 months after consent | Description of counts of RightMed test recommendations accepted by prescribers |
| Medication adherence | 6 and 12 months after consent | Mean/median changes in percent of days (PDC) covered for targeted medications |
| Pharmacy expenditures | 6 and 12 months after consent | Mean/median changes in outpatient prescription medication expenditures from the KPCO perspective |
Countries
United States
Outcome results
None listed