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The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251520
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mark K. Edwin, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Palliative Medicine Diagnostic Test: Pharmacogenomics testing Other: Pharmacist review Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
No Intervention: Control Group
Standard care by Palliative Medicine physician
Experimental: Intervention Group A
Standard care by Palliative medicine physician plus pharmacist review of medications
Other: Pharmacist review
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.

Experimental: Intervention Group B
Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review
Diagnostic Test: Pharmacogenomics testing
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.

Other: Pharmacist review
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251520


Locations
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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mark Edwin, MD Mayo Clinic
Additional Information:
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Responsible Party: Mark K. Edwin, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04251520    
Other Study ID Numbers: 18-010761
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark K. Edwin, Mayo Clinic:
Pharmacogenomics
Symptom management