Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
600 participants
INTERVENTIONAL
2019-11-15
2027-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
Pharmacogenomic 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.
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.
No interventions assigned to this group
Interventions
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Pharmacogenomic 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.
Eligibility Criteria
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Inclusion Criteria
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
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 -
18 Years
79 Years
ALL
No
Sponsors
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OneOme, LLC
INDUSTRY
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Alison Quinn, PharmD
Role: PRINCIPAL_INVESTIGATOR
KPCO
Locations
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Central Support Services
Aurora, Colorado, United States
Countries
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Other Identifiers
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1448074-3
Identifier Type: -
Identifier Source: org_study_id
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