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

Sponsor
Mayo Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT04251520
Collaborator
(none)
2
Enrollment
1
Location
3
Arms
8.9
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: Pharmacogenomics testing
  • Other: Pharmacist review
 N/A

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

Study Type:
Interventional
Actual Enrollment :
2 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
Actual Study Start Date :
Apr 15, 2021
Actual Primary Completion Date :
Jan 12, 2022
Actual Study Completion Date :
Jan 12, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Phoenix Arizona United States 85054

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Mark Edwin, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mark K. Edwin, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04251520
Other Study ID Numbers:
  • 18-010761
First Posted:
Feb 5, 2020
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mark K. Edwin, Principal Investigator, Mayo Clinic
Pharmacogenomics
Symptom management

Study Results

No Results Posted as of May 5, 2022