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

Not Applicable

Terminated

• Conditions: Palliative Medicine
• Interventions: Diagnostic Test: Pharmacogenomics testing; Other: Pharmacist review

• Registration Number: NCT04251520
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Study Start: 2021-04-15
• Primary Completion: 2022-01-12
• Study Completion: 2022-01-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group B	Pharmacist review	Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review
Intervention Group A	Pharmacist review	Standard care by Palliative medicine physician plus pharmacist review of medications
Intervention Group B	Pharmacogenomics testing	Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review

Primary Outcome Measures

Name	Time	Method
Change in symptom control	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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States