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

NCT ID: NCT04251520

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-01-12

Brief Summary

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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

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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.

Conditions

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Palliative Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

Standard care by Palliative Medicine physician

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group A

Standard care by Palliative medicine physician plus pharmacist review of medications

Group Type EXPERIMENTAL

Pharmacist review

Intervention Type OTHER

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 B

Standard care by Palliative medicine plus pharmacogenomics testing and pharmacist review

Group Type EXPERIMENTAL

Pharmacogenomics testing

Intervention Type DIAGNOSTIC_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.

Pharmacist review

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark K. Edwin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Edwin, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-010761

Identifier Type: -

Identifier Source: org_study_id

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