NCT04251520

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

January 30, 2020

Last Update Submit

May 3, 2022

Conditions

Palliative Medicine

Keywords

PharmacogenomicsSymptom management

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Other: Pharmacist review

Intervention Group B

EXPERIMENTAL

Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review

Diagnostic Test: Pharmacogenomics testingOther: Pharmacist review

Interventions

Pharmacogenomics testingDIAGNOSTIC_TEST

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.

Intervention Group B
Pharmacist reviewOTHER

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.

Intervention Group AIntervention Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Related Links

Study Officials

  • Mark Edwin, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

April 15, 2021

Primary Completion

January 12, 2022

Study Completion

January 12, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)