Adverse Drug EventNCT04984538
Implementation of a Pharmacist-led Pharmacogenomic Clinical Service
An observational study of Adverse Drug Event and Drug Drug Interaction, 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
- Adverse Drug Event, Drug Drug Interaction, Pharmacogenomics
- What is being tested?
- Pharmacogenomic Testing
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 30 Jan 2023
- 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: Tabula Rasa Healthcare (TRHC) partners with Programs of All-inclusive Care for the Elderly (PACE) that provides comprehensive medical and supportive services for community-dwelling persons, mostly older adults (>55 years), as an alternative to institutionalization. The aim of PACE is to improve overall quality of life in four domains (physical, psychological, social, and spiritual) using a multidisciplinary approach.
Who may be able to join
- Patients meeting all the following criteria will be included:
- Patient is enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period;
- Patient is able to understand, and provide informed consent to participate.
Who cannot join
- Patients with one of the following criteria will be excluded:
- Have taken an investigational product in the last 30 days;
- Current use of illicit substances;
- 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 and/or the prescriber.
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
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 (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 100 PACE sites, across the United States. 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. Pharmacist-led PGx clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Our aim is to extend and meticulously study PGx testing for more PACE patients and conduct a prospective preemptive PGx study to determine feasibility of implementation and effect on outcomes. After mutual agreement, these services may also be extended to other organizations where TRHC provides pharmacy services, and data will be collected with patient consent.
Read the detailed description
This project aims to include patients enrolled in PACE organizations or other healthcare organizations serviced by TRHC. PGx testing will be performed by a vendor contracted by TRHC (CLIA certified). Genetic testing for CYP450 isoforms like CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A5, and transporters like SLCO1B1, ABCB1, and ABCG2 will be conducted, along with other genes in individual vendors' testing panel. The results will be integrated into TRHC's proprietary CDSS (Medication Risk Mitigation Matrix, Tabula Rasa Healthcare, Moorestown, NJ). Phenotypes related to CYP450 isoforms will be used to guide 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 recommendations. Prescribers will review the pharmacist's recommendation, and based on their clinical assessment will decide whether or not to implement the therapy recommendation. Endpoints like number and type of pharmacist recommendations and uptake by physicians, follow-up drug regimens, and outcomes will be collected for up to 12 months [baseline (data from the previous year), 3, 6 and 12 months post-PGx intervention] for each patient to get a longitudinal perspective of implementing PGx into CDSS systems.
- Conditions
- Adverse Drug Event, Drug Drug Interaction, Pharmacogenomics, Elderly
- Being tested
- Pharmacogenomic Testing
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic TestingOther
Cheek swab as a part of routine care
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure success of implementation of the PGx consultation process, including TRHC's CDSS (providing patient-specific PGx and phenotypic reviews)
Quantitative
Measured: 1 year
Assess uptake of recommendations based on PGx is associated with improved outcomes in patients
Quantitative
Measured: 1 year
Secondary outcomes (2)
To determine usability of implementation of PGx consult during the process of medication review as measured by clinician response to survey.
Qualitative / Quantitative
Measured: 1 year
To determine the acceptability of recommendations provided on the basis of PGx information as measured by acceptance of the recommendation and changes in prescription made after information provided.
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 posted30 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Why it stopped: Personnel Changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug EventStudies 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
- Other
- Enrolment
- 0 participants (actual)
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
- NCT04984538
- Sponsor's protocol ID
- PGX-INITIATIVE-TRHC-2020-002
- Status last verified
- Jan 2023
- First submitted
- 21 Jul 2021
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Pharmacist-led Pharmacogenomic Clinical Service
- ClinicalTrials.gov ID
- NCT04984538
- Acronym / sponsor ID
- PGX-INITIATIVE-TRHC-2020-002
- Conditions
- Adverse Drug Event, Drug Drug Interaction, Pharmacogenomics, Elderly
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Personnel Changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 30 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.
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 (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 100 PACE sites, across the United States. 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. Pharmacist-led PGx clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Our aim is to extend and meticulously study PGx testing for more PACE patients and conduct a prospective preemptive PGx study to determine feasibility of implementation and effect on outcomes. After mutual agreement, these services may also be extended to other organizations where TRHC provides pharmacy services, and data will be collected with patient consent.
Detailed description
This project aims to include patients enrolled in PACE organizations or other healthcare organizations serviced by TRHC. PGx testing will be performed by a vendor contracted by TRHC (CLIA certified). Genetic testing for CYP450 isoforms like CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A5, and transporters like SLCO1B1, ABCB1, and ABCG2 will be conducted, along with other genes in individual vendors' testing panel. The results will be integrated into TRHC's proprietary CDSS (Medication Risk Mitigation Matrix, Tabula Rasa Healthcare, Moorestown, NJ). Phenotypes related to CYP450 isoforms will be used to guide 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 recommendations. Prescribers will review the pharmacist's recommendation, and based on their clinical assessment will decide whether or not to implement the therapy recommendation. Endpoints like number and type of pharmacist recommendations and uptake by physicians, follow-up drug regimens, and outcomes will be collected for up to 12 months [baseline (data from the previous year), 3, 6 and 12 months post-PGx intervention] for each patient to get a longitudinal perspective of implementing PGx into CDSS systems.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tabula Rasa Healthcare (TRHC) partners with Programs of All-inclusive Care for the Elderly (PACE) that provides comprehensive medical and supportive services for community-dwelling persons, mostly older adults (>55 years), as an alternative to institutionalization. The aim of PACE is to improve overall quality of life in four domains (physical, psychological, social, and spiritual) using a multidisciplinary approach.
Key inclusion criteria (3 listed)
- Patients meeting all the following criteria will be included:
Key exclusion criteria (4 listed)
- Patients with one of the following criteria will be excluded:
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 TestingCheek swab as a part of routine care | Other | – |
Primary outcome
To measure success of implementation of the PGx consultation process, including TRHC's CDSS (providing patient-specific PGx and phenotypic reviews)
Time frame: 1 year
Quantitative
Assess uptake of recommendations based on PGx is associated with improved outcomes in patients
Time frame: 1 year
Quantitative
2 secondary outcomes
To determine usability of implementation of PGx consult during the process of medication review as measured by clinician response to survey.
Time frame: 1 year
To determine the acceptability of recommendations provided on the basis of PGx information as measured by acceptance of the recommendation and changes in prescription made after information provided.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- 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 Adverse Drug Event and Drug Drug Interaction, 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 4 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: withdrawn, as of the sponsor's last update on 1 Feb 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To measure success of implementation of the PGx consultation process, including TRHC's CDSS (providing patient-specific PGx and phenotypic reviews) (time frame: 1 year). 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 1 Feb 2023.