Preemptive Pharmacogenomics Testing Among Geriatric Patients

April 25, 2024 updated by: Geisinger Clinic

Implementation and Evaluation of Preemptive Pharmacogenomics Testing in an Aging Population

The primary goal of this study is to conduct pharmacogenomics testing (a type of DNA test) within an aging population and measure the impact of this test on medication selection, dosing, healthcare utilization, and costs of care.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Pharmacogenomics is the study of how a patient's unique DNA may interact with medications that the patient currently takes or may take in the future. DNA may change how a patient reacts to a medication, such as changing how well it works or the side effects. Knowing a patient's DNA profile may help healthcare professionals select the best medication treatment plan to use. This could include selecting the best medication to give or the medication strength that will work best for the patient. Currently, there is no standard that helps healthcare professionals decide to order a pharmacogenomics test that includes multiple genes. The investigators of this study think that having these DNA results in the medical record for participants who are at least 65 years old and are taking 5 or more medications will result in better health since healthcare professionals may use these results for treatment planning. Knowing if this is true will help healthcare professionals decide if ordering this test will improve patient health.

This study seeks to recruit participants for a pharmacogenomic study who visit at Geisinger 65 Forward locations. Patients who meet the study requirements and consent to be enrolled in this study will be randomly put into a group that receives this pharmacogenomics test or a group that does not receive it. There is a 50% chance of being put in the group that receives this pharmacogenomics test. The investigators will follow all patients enrolled in this study as they visit with their healthcare providers in the future. Geisinger healthcare professionals will have access to the results of this test in the medical record.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Follows at a Geisinger 65 Forward clinic location
  • Active prescriptions for 5 or more medications

Exclusion Criteria:

  • Liver transplantation
  • Allogenic hematopoetic stem cell transplantation
  • Previously enrolled in the Electronic Medical Records and Genomics (eMERGE) pharmacogenomics cohort

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
A multigene pharmacogenomics test will not be ordered for patients in this study arm, as is the standard of care.
Experimental: Pharmacogenomics Testing
Patients in the experimental arm will be ordered a multigene pharmacogenomics test. This DNA test requires a blood draw, with the results expected to be reported in the medical record approximately 7 to 14 calendar days after the blood draw. These results will be made available to Geisinger healthcare professionals that have a treatment relationship with study participants.
Genetic: Multigene pharmacogenomics test
This multigene pharmacogenomics test will report genetic variation for genes that have Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pharmacogenomic results returned in patients' health records
Time Frame: Date of blood draw to test results reported in medical record, up to 1 month
The primary objective will be assessed by comparing the total number of patients with returned results in the electronic health record (EHR) with the total number of tested patients.
Date of blood draw to test results reported in medical record, up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of changes to medication therapy
Time Frame: Date of test results reported to end of study, up to 5 years
The number of medication changes (e.g. dose or agent change) that healthcare professionals initiate due to pharmacogenomics return of results.
Date of test results reported to end of study, up to 5 years
Number of hospitalizations
Time Frame: Date of test results reported to end of study, up to 5 years
The number of hospitalizations patients encounter after receiving pharmacogenomics results
Date of test results reported to end of study, up to 5 years
Number of ambulatory visits
Time Frame: Date of test results reported to end of study, up to 5 years
The number of outpatient clinic visits patients encounter.
Date of test results reported to end of study, up to 5 years
Costs of clinical care
Time Frame: Date of test results reported to end of study, up to 5 years
The total healthcare costs of patients.
Date of test results reported to end of study, up to 5 years
Medical costs of care
Time Frame: Date of test results reported to end of study, up to 5 years
Measure of the costs of medical care (e.g. hospitalizations, outpatient visits, etc.), excluding pharmacy services.
Date of test results reported to end of study, up to 5 years
Pharmacy costs of care
Time Frame: Date of test results reported to end of study, up to 5 years
Measure of the costs of all pharmacy services (e.g. medications, consults, etc.).
Date of test results reported to end of study, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Ryley Uber, Pharm.D., Geisinger Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-1103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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