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Clinical Trials/NCT04251520
NCT04251520TerminatedNot Applicable

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

Mayo Clinic1 site in 1 country2 target enrollmentStarted: April 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2
Locations
1
Primary Endpoint
Change in symptom control

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Control Group

No Intervention

Standard care by Palliative Medicine physician

Intervention Group A

Experimental

Standard care by Palliative medicine physician plus pharmacist review of medications

Intervention: Pharmacist review (Other)

Intervention Group B

Experimental

Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review

Intervention: Pharmacogenomics testing (Diagnostic Test)

Intervention Group B

Experimental

Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review

Intervention: Pharmacist review (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mark K. Edwin

Principal Investigator

Mayo Clinic

Study Sites (1)

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