PharmacogenomicsNCT05053815
Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting
An observational study of Pharmacogenomics and Polypharmacy, run by Tabula Rasa HealthCare at 1 site in United States.
Trial summary
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacogenomics, Polypharmacy
- What is being tested?
- Pharmacogenomic Testing
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in PACE are 55 years of age and older and are eligible for Medicare and Medicaid.
Who may be able to join
- Patient received PGx testing; and
- Patient enrolled in a PACE organization when PGx test results were returned; and
- PACE organization contractually received pharmacy services from CareKinesis upon PGx return of results.
Who cannot join
- Patient did not receive PGx test results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute
Orlando, Florida, 32827
About this study
Official title: Retrospective Study Assessing the Value of Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations.
Program of All-inclusive Care for the Elderly (PACE) is a Medicare-Medicaid program that provides comprehensive medical and supportive services to individuals >55 years of age who are certified by their state as needing nursing home care. As an alternative to institutionalization, PACE helps these individuals live safely in their community. The aim of PACE is to improve overall quality of life in four domains (physical, psychological, social, and spiritual) using a multidisciplinary approach. In the United States, the vast majority of PACE organizations collaborate with one pharmacy to dispense drugs, in addition to other pharmacy services, for their population of participants. Presently, CareKinesis services approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes.
Read the detailed description
Pharmacist-led pharmacogenomics (PGx) clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by CareKinesis d/b/a Tabula Rasa HealthCare. This project aims to include patients enrolled in the PACE organization who received PGx testing. PGx testing was performed by one of several contracted PGx vendors with TRHC (e.g., Corriel, CQuentia, OneOme) at the time. Upon return from the laboratory, PGx results were integrated into TRHC's proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides pharmacists to identify DDIs, DGIs, and DDGIs. As part of this workflow, clinical pharmacists utilized PGx results combined with a comprehensive DDI review (via PGx consult, medication safety review, and/or polypharmacy call) to inform their recommendations to PACE prescribers to address medication problems, including those related to DDIs, DGIs, and/or DDGIs (drug-induced phenoconversion). Upon reviewing the pharmacist's recommendation(s) and based on their clinical assessment, PACE prescribers decided whether to implement the recommended changes. This current study plans to collect data retrospectively from the past six years (2016-2021) on specific PGx test results, genotype-guided and interacting drugs, and recommendations, in order to look for any patterns that may help optimize the process of PGx consultation and/or PGx-guided recommendations, with the ultimate goal of reducing adverse drug events and improving patient outcomes.
- Conditions
- Pharmacogenomics, Polypharmacy
- Being tested
- Pharmacogenomic Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic TestingOther
Pharmacogenomic testing is done via buccal swab. As this study is retrospective, data from PGx testing has already been collected as a part of routine care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the value of PGx testing for pharmacogenes and subsequent CDSS-informed, pharmacist-led PGx consultation and its impact on recommendations and prescribing decisions.
Quantitative
Measured: 1 year
Measure PGx-guided interventions on improvement of therapy response.
Quantitative
Measured: 1 year
Measure PGx-guided interventions on improvement of adverse drug events.
Quantitative
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start2 Nov 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacogenomicsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabula Rasa HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronique Michaud, Principal investigator, Tabula Rasa HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053815
- Sponsor's protocol ID
- TRHC-PACE-PGX-2021-001
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2021
- Last updated
- 2 Sep 2022
- 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 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Assessing the Value of Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting
- ClinicalTrials.gov ID
- NCT05053815
- Acronym / sponsor ID
- TRHC-PACE-PGX-2021-001
- Conditions
- Pharmacogenomics, Polypharmacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 23 Sep 2021 (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.
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations.
Program of All-inclusive Care for the Elderly (PACE) is a Medicare-Medicaid program that provides comprehensive medical and supportive services to individuals >55 years of age who are certified by their state as needing nursing home care. As an alternative to institutionalization, PACE helps these individuals live safely in their community. The aim of PACE is to improve overall quality of life in four domains (physical, psychological, social, and spiritual) using a multidisciplinary approach. In the United States, the vast majority of PACE organizations collaborate with one pharmacy to dispense drugs, in addition to other pharmacy services, for their population of participants. Presently, CareKinesis services approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes.
Detailed description
Pharmacist-led pharmacogenomics (PGx) clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by CareKinesis d/b/a Tabula Rasa HealthCare. This project aims to include patients enrolled in the PACE organization who received PGx testing. PGx testing was performed by one of several contracted PGx vendors with TRHC (e.g., Corriel, CQuentia, OneOme) at the time. Upon return from the laboratory, PGx results were integrated into TRHC's proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides pharmacists to identify DDIs, DGIs, and DDGIs. As part of this workflow, clinical pharmacists utilized PGx results combined with a comprehensive DDI review (via PGx consult, medication safety review, and/or polypharmacy call) to inform their recommendations to PACE prescribers to address medication problems, including those related to DDIs, DGIs, and/or DDGIs (drug-induced phenoconversion). Upon reviewing the pharmacist's recommendation(s) and based on their clinical assessment, PACE prescribers decided whether to implement the recommended changes. This current study plans to collect data retrospectively from the past six years (2016-2021) on specific PGx test results, genotype-guided and interacting drugs, and recommendations, in order to look for any patterns that may help optimize the process of PGx consultation and/or PGx-guided recommendations, with the ultimate goal of reducing adverse drug events and improving patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in PACE are 55 years of age and older and are eligible for Medicare and Medicaid.
Key inclusion criteria (3 listed)
- Patient received PGx testing; and
- Patient enrolled in a PACE organization when PGx test results were returned; and
- PACE organization contractually received pharmacy services from CareKinesis upon PGx return of results.
Key exclusion criteria (1 listed)
- Patient did not receive PGx test results.
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 TestingPharmacogenomic testing is done via buccal swab. As this study is retrospective, data from PGx testing has already been collected as a part of routine care. | Other | – |
Primary outcome
Evaluate the value of PGx testing for pharmacogenes and subsequent CDSS-informed, pharmacist-led PGx consultation and its impact on recommendations and prescribing decisions.
Time frame: 1 year
Quantitative
Measure PGx-guided interventions on improvement of therapy response.
Time frame: 1 year
Quantitative
Measure PGx-guided interventions on improvement of adverse drug events.
Time frame: 1 year
Quantitative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- 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.
Veronique Michaud principal investigator
Tabula Rasa HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacogenomics and Polypharmacy, run by Tabula Rasa HealthCare 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. 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?
Results are not available in the source record.
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?
Evaluate the value of PGx testing for pharmacogenes and subsequent CDSS-informed, pharmacist-led PGx consultation and its impact on recommendations and prescribing decisions. (time frame: 1 year). The study lists 3 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 Sep 2022.