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

Palliative Medicine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04251520
• Other study ID #: 18-010761
• Status: Terminated
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: January 12, 2022

Study information

• Verified date: May 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 12, 2022
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palliative Medicine

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline,1, 2, 4, and 6 months

External Links

•   Mayo Clinic Clinical Trials