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

Study Overview
=================
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.

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

Conditions
-----------------
Palliative Medicine

Intervention / Treatment
-----------------
* Diagnostic Test: Pharmacogenomics testing
* Other: Pharmacist review


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Standard care by Palliative Medicine physician | |
| Experimental: Intervention Group A<br>Standard care by Palliative medicine physician plus pharmacist review of medications | Other: Pharmacist review<br>* 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.<br>|
| Experimental: Intervention Group B<br>Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review | Diagnostic Test: Pharmacogenomics testing<br>* 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.<br>Other: Pharmacist review<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacogenomics, Symptom management