Palliative MedicineNCT04251520
The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients
A study testing Pharmacogenomics testing and Pharmacist review in people with Palliative Medicine, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to learn more about how pharmacists and pharmacogenomic testing can help care providers improve control of symptoms and quality of life in seriously ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Medicine
- What is being tested?
- Pharmacogenomics testing and Pharmacist review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 12 Jan 2022
- Phase
- Interventional
- 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
Who may be able to join
- English speaking
- Age 18 years and older
- Palliative Medicine is consulted for the first time in either the outpatient setting for symptom management and plan to continue to follow up with the Palliative Medicine team in the outpatient setting for the foreseeable future.
- Insurance accepted at Mayo Clinic Arizona.
- Live within metro Phoenix area.
Who cannot join
- Vulnerable adults
- Under 18 years of age
- Pregnant Patients
- Subjects whose medical insurance requires use of specific pharmacies
- Non English Speaking Patients
- Patients that lack capacity for medical decision making
Show all 10Show fewer
- Patients who live outside the metro Phoenix area
- Patients who are lost to follow up secondary to enrolling in hospice, die or failure to show or answer surveys within 2 months of enrollment.
- Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
- Patient's previously established within the Palliative Medicine Clinic who receive ongoing Palliative Medicine services.
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to learn more about how pharmacists and pharmacogenomic testing can help care providers improve control of symptoms and quality of life in seriously ill patients.
Read the detailed description
Participants in the study will be randomized to A) standard of care, B) standard of care with medication therapy management provided by a pharmacist, or C) standard of care with medication therapy management by a pharmacist who has access to the patient's pharmacogenomics profile accessible to guide them. We will be measuring level of symptom control in each group over the subsequent 6 months.
- Conditions
- Palliative Medicine
- Being tested
- Pharmacogenomics testing, Pharmacist review
- Keywords
- Pharmacogenomics, Symptom management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomics testingDiagnostic test
Participants will undergo pharmacogenomics testing and will be asked to provide a one-time buccal scraping. These results will be utilized for clinical treatment decisions.
Pharmacist reviewOther
Participants will have their medical information, including patient demographics, problem list, medication list, allergies, and relevant lab work reviewed by a One Point pharmacist. The pharmacist will work with the Palliative Medicine team to make medication related recommendations to improve individual patient care. The pharmacist will call the patient roughly 48 hours following their outpatient consultation or hospital discharge to review the medication list and address any medication-related questions. The pharmacy will send refill reminders to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Standard care by Palliative Medicine physician |
| Intervention Group A | Experimental | Standard care by Palliative medicine physician plus pharmacist review of medications Receives: Other: Pharmacist review |
| Intervention Group B | Experimental | Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review Receives: Diagnostic Test: Pharmacogenomics testing; Other: Pharmacist review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom control
Measure using the self-reported Edmonton Symptom Assessment scale where a lower score indicates good symptom control and higher score indicates poor symptom control
Measured: Baseline,1, 2, 4, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Apr 2021
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative MedicineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark K. Edwin, Mayo Clinic
- Investigators
- Mark Edwin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251520
- Sponsor's protocol ID
- 18-010761
- Status last verified
- May 2022
- First submitted
- 30 Jan 2020
- Last updated
- 5 May 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients
- ClinicalTrials.gov ID
- NCT04251520
- Acronym / sponsor ID
- 18-010761
- Conditions
- Palliative Medicine
- Keywords
- Pharmacogenomics, Symptom management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 5 Feb 2020 (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.
Researchers are trying to learn more about how pharmacists and pharmacogenomic testing can help care providers improve control of symptoms and quality of life in seriously ill patients.
Detailed description
Participants in the study will be randomized to A) standard of care, B) standard of care with medication therapy management provided by a pharmacist, or C) standard of care with medication therapy management by a pharmacist who has access to the patient's pharmacogenomics profile accessible to guide them. We will be measuring level of symptom control in each group over the subsequent 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard care by Palliative Medicine physician |
| Intervention Group A | Experimental | Other: Pharmacist reviewStandard care by Palliative medicine physician plus pharmacist review of medications |
| Intervention Group B | Experimental | Diagnostic Test: Pharmacogenomics testing, Other: Pharmacist reviewStandard care by Palliative medicine plus pharmacogenomics testing and pharmacist review |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking
- Age 18 years and older
- Palliative Medicine is consulted for the first time in either the outpatient setting for symptom management and plan to continue to follow up with the Palliative Medicine team in the outpatient setting for the foreseeable future.
- Insurance accepted at Mayo Clinic Arizona.
- Live within metro Phoenix area.
Key exclusion criteria (10 listed)
- Vulnerable adults
- Under 18 years of age
- Pregnant Patients
- Subjects whose medical insurance requires use of specific pharmacies
- Non English Speaking Patients
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 |
|---|---|---|
| Pharmacogenomics testingParticipants will undergo pharmacogenomics testing and will be asked to provide a one-time buccal scraping. These results will be utilized for clinical treatment decisions. | Diagnostic test | Intervention Group B |
| Pharmacist reviewParticipants will have their medical information, including patient demographics, problem list, medication list, allergies, and relevant lab work reviewed by a One Point pharmacist. The pharmacist will work with the Palliative Medicine team to make medication related recommendations to improve individual patient care. The pharmacist will call the patient roughly 48 hours following their outpatient consultation or hospital discharge to review the medication list and address any medication-related questions. The pharmacy will send refill reminders to the patients. | Other | Intervention Group A, Intervention Group B |
Primary outcome
Change in symptom control
Time frame: Baseline,1, 2, 4, and 6 months
Measure using the self-reported Edmonton Symptom Assessment scale where a lower score indicates good symptom control and higher score indicates poor symptom control
Results and safety
The study was stopped early (reason given: Unable to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Mark Edwin, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomics testing and Pharmacist review in people with Palliative Medicine, run by Mayo Clinic 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 May 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?
The study was stopped early (reason given: Unable to recruit participants). 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?
Change in symptom control (time frame: Baseline,1, 2, 4, and 6 months). 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 5 May 2022.