PharmacogenomicsNCT05346770
Pharmacist-led Interventions to Improve Medication Use
An observational study of Pharmacogenomics and Old Age, run by Tabula Rasa HealthCare at 1 site in United States.
Trial summary
The objective of this project is to stimulate identification and report of patient's medical story for whom their clinical conditions beneficiated from pharmacists' interventions based on a medication safety review. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacogenomics, Old Age
- What is being tested?
- Behavioral Intervention, Diagnostic Test and Data Analysis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 24 Jul 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
- Adult, Older adult
Study population: Patient enrolled in a healthcare organization where Tabula Rasa Healthcare provides pharmacy services during the implementation period.
Who may be able to join
- Patients meeting all the following criteria will be considered:
- Patient enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period.
- Patient (or legal representative) able to understand, and provide informed consent to publish his/her case story.
- Patient's case will provide generalizable knowledge to the existing literature based on direct observation, interview, benign behavioral intervention, or findings from drug regimen or drugs claims data.
Who cannot join
- Patients with one of the following criteria will be excluded:
- Patient's refusal to participate in a case study
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 Interventions to Improve Medication Use: Series of Case-reports
The objective of this project is to stimulate identification and report of patient's medical story for whom their clinical conditions beneficiated from pharmacists' interventions based on a medication safety review. Cases will be systematically identified and reported in the scientific (peer review journals) and clinical communities in order to inform and provide better care.
Read the detailed description
METHODS TRHC aims to collect data about participants using direct or retrospective observations such as patient's demographics, medical lab tests, clinical decision support systems, and examination of medical records and drugs. Specific case studies could include medication safety reviews, behavioral interventions, pharmacogenomic testings (PGx), and prospective or retrospective analyses of a patient's drug regimen, or medical records. Case reports covered under this protocol will be limited to single case reports.
TRHC pharmacists will maintain their routine health care practices. TRHC clinical research scientists and/or pharmacy residents will provide assistance and guidance. The writing process will be performed and supervised by TRHC scientist researchers.
Setting and Practice Description TRHC, d/b/a 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). In addition, TRHC provides risk stratification and medication safety review for non-PACE organizations and national health plans to identify trends in medication prescribing, and healthcare expenditures by risk level. This allows TRHC (CareKinesis) to assess large populations throughout the United States to validate the MedWise® clinical decision support system.
Each case report will be limited to a single patient.
- Conditions
- Pharmacogenomics, Old Age
- Being tested
- Behavioral Intervention, Diagnostic Test, Data Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
A behavioral intervention could include changing the time of day a drug is taken.
Diagnostic TestDiagnostic test
A patient may receive a pharmacogenomic test via cheek swab to find PGx results. This is a benign intervention with little to no risk to the patient.
Data AnalysisOther
Medication safety reviews, and retrospective or prospective data analysis may occur as a result of participation in a case study.
| Study group | Role | What they receive |
|---|---|---|
| Individual Patient | Each case will represent one individual patient and patient case. The cases may not be related and may cover different clinical practice areas. Receives: Behavioral: Behavioral Intervention; Diagnostic Test: Diagnostic Test; Other: Data Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication safety reviews of patient drug regimen characteristics will be conducted to determine potential drug-drug interactions.
Medication safety reviews will be conducted and reported using Tabula Rasa Healthcare proprietary software MedWise to assign a Medication Risk Score. This evaluation incorporates over-the-counter medications, herbals, and supplements to illuminate simultaneous, multi-drug interactions. Based on the data, patients are assigned a risk score ranging from 0 to 50, where 0-9 indicates minimal risk, 10-14 indicates low risk, 15-19 indicates intermediate risk, 20-29 indicates high risk, and 30 and above indicates severe risk.
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 posted26 Apr 2022
- Study start25 Jan 2022
- Primary completion24 Jan 2024 (estimated)
- Study completion24 Jul 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 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, TRHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346770
- Sponsor's protocol ID
- TRHC-CS-2021-001
- Status last verified
- Sep 2022
- First submitted
- 2 Mar 2022
- 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 Interventions to Improve Medication Use: Series of Case-reports
- ClinicalTrials.gov ID
- NCT05346770
- Acronym / sponsor ID
- TRHC-CS-2021-001
- Conditions
- Pharmacogenomics, Old Age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 24 Jan 2024 (estimated)
- Study completion
- 24 Jul 2024 (estimated)
- First posted
- 26 Apr 2022 (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 objective of this project is to stimulate identification and report of patient's medical story for whom their clinical conditions beneficiated from pharmacists' interventions based on a medication safety review. Cases will be systematically identified and reported in the scientific (peer review journals) and clinical communities in order to inform and provide better care.
Detailed description
METHODS TRHC aims to collect data about participants using direct or retrospective observations such as patient's demographics, medical lab tests, clinical decision support systems, and examination of medical records and drugs. Specific case studies could include medication safety reviews, behavioral interventions, pharmacogenomic testings (PGx), and prospective or retrospective analyses of a patient's drug regimen, or medical records. Case reports covered under this protocol will be limited to single case reports.
TRHC pharmacists will maintain their routine health care practices. TRHC clinical research scientists and/or pharmacy residents will provide assistance and guidance. The writing process will be performed and supervised by TRHC scientist researchers.
Setting and Practice Description TRHC, d/b/a 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). In addition, TRHC provides risk stratification and medication safety review for non-PACE organizations and national health plans to identify trends in medication prescribing, and healthcare expenditures by risk level. This allows TRHC (CareKinesis) to assess large populations throughout the United States to validate the MedWise® clinical decision support system.
Each case report will be limited to a single patient.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individual Patient | – | Behavioral: Behavioral Intervention, Diagnostic Test: Diagnostic Test, Other: Data AnalysisEach case will represent one individual patient and patient case. The cases may not be related and may cover different clinical practice areas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient enrolled in a healthcare organization where Tabula Rasa Healthcare provides pharmacy services during the implementation period.
Key inclusion criteria (4 listed)
- Patient enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period.
- Patient (or legal representative) able to understand, and provide informed consent to publish his/her case story.
- Patient's case will provide generalizable knowledge to the existing literature based on direct observation, interview, benign behavioral intervention, or findings from drug regimen or drugs claims data.
Key exclusion criteria (2 listed)
- Patient's refusal to participate in a case study
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 |
|---|---|---|
| Behavioral InterventionA behavioral intervention could include changing the time of day a drug is taken. | Behavioural | Individual Patient |
| Diagnostic TestA patient may receive a pharmacogenomic test via cheek swab to find PGx results. This is a benign intervention with little to no risk to the patient. | Diagnostic test | Individual Patient |
| Data AnalysisMedication safety reviews, and retrospective or prospective data analysis may occur as a result of participation in a case study. | Other | Individual Patient |
Primary outcome
Medication safety reviews of patient drug regimen characteristics will be conducted to determine potential drug-drug interactions.
Time frame: 1 year
Medication safety reviews will be conducted and reported using Tabula Rasa Healthcare proprietary software MedWise to assign a Medication Risk Score. This evaluation incorporates over-the-counter medications, herbals, and supplements to illuminate simultaneous, multi-drug interactions. Based on the data, patients are assigned a risk score ranging from 0 to 50, where 0-9 indicates minimal risk, 10-14 indicates low risk, 15-19 indicates intermediate risk, 20-29 indicates high risk, and 30 and above indicates severe risk.
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
TRHC
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 Old Age, 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 4 inclusion and 2 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?
Medication safety reviews of patient drug regimen characteristics will be conducted to determine potential drug-drug interactions. (time frame: 1 year). 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.