PolypharmacyNCT04120480
Effectiveness of PGx Testing
A study testing Pharmacogenomic test in people with Polypharmacy, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Pharmacogenomic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Economic Effectiveness of Pharmacogenomic (PGx) Testing in Patients With Polypharmacy
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.
Read the 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:
- 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:
- Medication changes: Counts of 6-month medication and/or dose adjustments in targeted medications
- Medication congruence: Description of counts of RightMed test recommendations accepted by prescribers
- Medication adherence: 6- and 12-month changes in percent of days (PDC) covered for targeted medications
- Pharmacy expenditures: 6- and 12-month changes in outpatient prescription medication expenditures from the KPCO perspective
- Conditions
- Polypharmacy
- Being tested
- Pharmacogenomic test
- Keywords
- Genomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Testing | Experimental | 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). Receives: Diagnostic Test: Pharmacogenomic test |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare expenditures
Changes in mean/median total healthcare expenditures from the KPCO perspective
Measured: 6 and 12 months after consent
Healthcare utilization
Changes in the proportion with at least one and mean/median count of hospitalization, emergency room visit, medical office visit, and telephone encounter
Measured: 6 and 12 months after consent
Secondary outcomes (4)
Medication changes
Mean/median counts of medication and/or dose adjustments in targeted medications
Measured: 6 months after consent
Medication congruence
Description of counts of RightMed test recommendations accepted by prescribers
Measured: 6 months after consent
Medication adherence
Mean/median changes in percent of days (PDC) covered for targeted medications
Measured: 6 and 12 months after consent
Pharmacy expenditures
Mean/median changes in outpatient prescription medication expenditures from the KPCO perspective
Measured: 6 and 12 months after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start15 Nov 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- OneOme, LLC
- Responsible party
- Sponsor
- Investigators
- Alison Quinn, PharmD, Principal investigator, KPCO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120480
- Sponsor's protocol ID
- 1448074-3
- Status last verified
- Aug 2024
- First submitted
- 7 Oct 2019
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Effectiveness of Pharmacogenomic (PGx) Testing in Patients With Polypharmacy
- ClinicalTrials.gov ID
- NCT04120480
- Acronym / sponsor ID
- 1448074-3
- Conditions
- Polypharmacy
- Keywords
- Genomics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- OneOme, LLC
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Medication changes: Counts of 6-month medication and/or dose adjustments in targeted medications
- Medication congruence: Description of counts of RightMed test recommendations accepted by prescribers
- Medication adherence: 6- and 12-month changes in percent of days (PDC) covered for targeted medications
- Pharmacy expenditures: 6- and 12-month changes in outpatient prescription medication expenditures from the KPCO perspective
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing | Experimental | Diagnostic Test: Pharmacogenomic testParticipants 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). |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomic testThe 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. | Diagnostic test | Testing |
Primary outcome
Healthcare expenditures
Time frame: 6 and 12 months after consent
Changes in mean/median total healthcare expenditures from the KPCO perspective
Healthcare utilization
Time frame: 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
4 secondary outcomes
Medication changes
Time frame: 6 months after consent
Medication congruence
Time frame: 6 months after consent
Medication adherence
Time frame: 6 and 12 months after consent
Pharmacy expenditures
Time frame: 6 and 12 months after consent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Quinn, PharmD principal investigator
KPCO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomic test in people with Polypharmacy, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare expenditures (time frame: 6 and 12 months after consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024; AzTrials last refreshed its copy on 27 Oct 2026.