Pharmacogenetic TestingNCT04971902
Pharmacist-led Pharmacogenomic Clinical Service Within the Program of All-inclusive Care for the Elderly
An observational study of Pharmacogenetic Testing and Elderly, run by Tabula Rasa HealthCare at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Pharmacogenetic Testing, Elderly, Opioid Use
- What is being tested?
- Pharmacogenetic Test
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Aug 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 55 years and older
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- Patient enrolled in a PACE organization during the implementation period; and,
- PACE organization contractually receiving pharmacy services from CareKinesis
- Patient prescribed a CYP2D6 activated opioid, namely codeine, hydrocodone, oxycodone and/or tramadol
- Patients with chronic non-cancer pain (CNCP)
- Patient's prescriber orders a PGx test based upon his/her determination that the patient could potentially benefit from PGx testing
- Patient is able to read, understand, and provide informed consent to participate
Who cannot join
- Patient prescribed an opioid that is not metabolized by CYP2D6 including, but not limited to, oxymorphone, morphine, hydromorphone
- Have taken an investigational product in the last 30 days
- Current use of illicit substances
- Immediate family members of site staff, or site staff may not be enrolled in the study without first obtaining IRB authorization
- Any other medical, cognitive or physical abnormality, disease, or disorder that would prohibit the patient from completing study procedures in the judgement of the investigator
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: Pharmacist-led Pharmacogenomic Clinical Service Within the Program of All-inclusive Care for the Elderly (PACE)
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 PACE organizations with chronic pain and who are prescribed CYP2D6 activated opioids. PGx testing will be performed by contractual PGx vendor with TRHC. PGx results will be integrated into TRHC's proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides pharmacists to identify drug-drug interactions (DDIs), drug-gene interactions (DGIs), and drug-drug-gene interactions (DDGIs).16 Clinical pharmacists will translate PGx results combined with a comprehensive DDI review into actionable clinical decisions. Clinical pharmacists will provide medication therapy management recommendation to address medication problems to the PACE prescriber (physician). PACE prescribers will review the pharmacist's recommendation, and based on their clinical assessment, the prescriber will decide whether or not to implement the opioid therapy recommendation.
Read the detailed description
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.15 Presently, CareKinesis services more than 35 PACE organizations, including approximately 75 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.
Study Design 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 PACE organizations with chronic pain and who are prescribed CYP2D6 activated opioids. PGx testing will be performed by a contractual PGx vendor with TRHC. PGx results will be integrated into TRHC's proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides pharmacists to identify drug-drug interactions (DDIs), drug-gene interactions (DGIs), and drug-drug-gene interactions (DDGIs).16 Clinical pharmacists will translate PGx results combined with a comprehensive DDI review into actionable clinical decisions. Clinical pharmacists will provide medication therapy management recommendation to address medication problems to the PACE prescriber (physician). PACE prescribers will review the pharmacist's recommendation, and based on their clinical assessment, the prescriber will decide whether or not to implement the opioid therapy recommendation.
The measurement of health-related quality of life (QoL) and pain assessment using the EQ-5D survey, and numerical rating scale (NRS) for pain will be performed during the study by PACE prescribers or the PACE interdisciplinary team (IDT) as follows:
- Health-related quality of life questionnaire (EQ-5D) will be performed at baseline and at the completion of the study (visits 1 and 3, respectively)
- NRS for pain will be performed at baseline (before the PGx testing), 1-2 and 2-3 weeks after TRHC's pharmacist recommendations (visits 1, 2 and 3, respectively) All PACE patients will continue to receive usual medical care throughout the study. Changes to drug regimens will be at the discretion of the patients' PACE prescribers.
- Conditions
- Pharmacogenetic Testing, Elderly, Opioid Use, Pain, Pain, Acute, Pain, Chronic
- Being tested
- Pharmacogenetic Test
- Medical subject headings
- Pain, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic TestOther
Cheek swab sample with PGx results lab analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for CYP2D6 opioid prescription and PGx recommendations by usability and acceptability through physician and pharmacist questionnaire.
Quantitative data reported via survey
Measured: 6 months
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for PGx recommendations by acceptability through physician and pharmacist questionnaire.
Quantitative data reported via survey
Measured: 6 months
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for PGx recommendations by usability through physician and pharmacist questionnaire.
Quantitative data reported via survey
Measured: 6 months
Analyze patient medication information for PGx- and DDI-guided recommendations using MedWise(TM) a proprietary clinical decision support system by Tabula Rasa HealthCare.
Quantitative (software is proprietary and patented)
Measured: 6 months
Analyze clinician uptake of PGx- and DDI-guided recommendations using MedWise(TM) a proprietary clinical decision support system by Tabula Rasa HealthCare.
Quantitative (software is proprietary and patented)
Measured: 6 months
Validate patient QOL questionnaire for disease-related information
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
Measured: 6 months
Validate patient QOL questionnaire for pharmacogenetics information
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
Measured: 6 months
Validate patient QOL questionnaire for medication-related information, and pharmacogenetics information
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
Measured: 6 months
Validate patient QOL questionnaire for socio-demographics
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacogenetic TestingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabula Rasa HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronique Michaud, PhD, Principal investigator, Tabula Rasa HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971902
- Sponsor's protocol ID
- PGX-PACE-2020-001
- Status last verified
- Sep 2022
- First submitted
- 15 Feb 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
- Pharmacist-led Pharmacogenomic Clinical Service Within the Program of All-inclusive Care for the Elderly (PACE)
- ClinicalTrials.gov ID
- NCT04971902
- Acronym / sponsor ID
- PGX-PACE-2020-001
- Conditions
- Pharmacogenetic Testing, Elderly, Opioid Use, Pain, Pain, Acute, Pain, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Jul 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.
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 PACE organizations with chronic pain and who are prescribed CYP2D6 activated opioids. PGx testing will be performed by contractual PGx vendor with TRHC. PGx results will be integrated into TRHC's proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides pharmacists to identify drug-drug interactions (DDIs), drug-gene interactions (DGIs), and drug-drug-gene interactions (DDGIs).16 Clinical pharmacists will translate PGx results combined with a comprehensive DDI review into actionable clinical decisions. Clinical pharmacists will provide medication therapy management recommendation to address medication problems to the PACE prescriber (physician). PACE prescribers will review the pharmacist's recommendation, and based on their clinical assessment, the prescriber will decide whether or not to implement the opioid therapy recommendation.
Detailed description
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.15 Presently, CareKinesis services more than 35 PACE organizations, including approximately 75 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.
Study Design 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 PACE organizations with chronic pain and who are prescribed CYP2D6 activated opioids. PGx testing will be performed by a contractual PGx vendor with TRHC. PGx results will be integrated into TRHC's proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides pharmacists to identify drug-drug interactions (DDIs), drug-gene interactions (DGIs), and drug-drug-gene interactions (DDGIs).16 Clinical pharmacists will translate PGx results combined with a comprehensive DDI review into actionable clinical decisions. Clinical pharmacists will provide medication therapy management recommendation to address medication problems to the PACE prescriber (physician). PACE prescribers will review the pharmacist's recommendation, and based on their clinical assessment, the prescriber will decide whether or not to implement the opioid therapy recommendation.
The measurement of health-related quality of life (QoL) and pain assessment using the EQ-5D survey, and numerical rating scale (NRS) for pain will be performed during the study by PACE prescribers or the PACE interdisciplinary team (IDT) as follows:
- Health-related quality of life questionnaire (EQ-5D) will be performed at baseline and at the completion of the study (visits 1 and 3, respectively)
- NRS for pain will be performed at baseline (before the PGx testing), 1-2 and 2-3 weeks after TRHC's pharmacist recommendations (visits 1, 2 and 3, respectively) All PACE patients will continue to receive usual medical care throughout the study. Changes to drug regimens will be at the discretion of the patients' PACE prescribers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- Patient enrolled in a PACE organization during the implementation period; and,
- PACE organization contractually receiving pharmacy services from CareKinesis
- Patient prescribed a CYP2D6 activated opioid, namely codeine, hydrocodone, oxycodone and/or tramadol
- Patients with chronic non-cancer pain (CNCP)
- Patient's prescriber orders a PGx test based upon his/her determination that the patient could potentially benefit from PGx testing
Key exclusion criteria (5 listed)
- Patient prescribed an opioid that is not metabolized by CYP2D6 including, but not limited to, oxymorphone, morphine, hydromorphone
- Have taken an investigational product in the last 30 days
- Current use of illicit substances
- Immediate family members of site staff, or site staff may not be enrolled in the study without first obtaining IRB authorization
- Any other medical, cognitive or physical abnormality, disease, or disorder that would prohibit the patient from completing study procedures in the judgement of the investigator
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 |
|---|---|---|
| Pharmacogenetic TestCheek swab sample with PGx results lab analysis | Other | – |
Primary outcome
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for CYP2D6 opioid prescription and PGx recommendations by usability and acceptability through physician and pharmacist questionnaire.
Time frame: 6 months
Quantitative data reported via survey
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for PGx recommendations by acceptability through physician and pharmacist questionnaire.
Time frame: 6 months
Quantitative data reported via survey
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for PGx recommendations by usability through physician and pharmacist questionnaire.
Time frame: 6 months
Quantitative data reported via survey
Analyze patient medication information for PGx- and DDI-guided recommendations using MedWise(TM) a proprietary clinical decision support system by Tabula Rasa HealthCare.
Time frame: 6 months
Quantitative (software is proprietary and patented)
Analyze clinician uptake of PGx- and DDI-guided recommendations using MedWise(TM) a proprietary clinical decision support system by Tabula Rasa HealthCare.
Time frame: 6 months
Quantitative (software is proprietary and patented)
Validate patient QOL questionnaire for disease-related information
Time frame: 6 months
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
Validate patient QOL questionnaire for pharmacogenetics information
Time frame: 6 months
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
Validate patient QOL questionnaire for medication-related information, and pharmacogenetics information
Time frame: 6 months
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
Validate patient QOL questionnaire for socio-demographics
Time frame: 6 months
Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results
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, PhD 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 Pharmacogenetic Testing and Elderly, 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 6 inclusion and 5 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?
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for CYP2D6 opioid prescription and PGx recommendations by usability and acceptability through physician and pharmacist questionnaire. (time frame: 6 months). The study lists 9 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.