Preemptive Pharmacogenomics Testing Among Geriatric Patients

Geisinger Health

Status: Invitation-only

Conditions: Polypharmacy; Pharmacogenomic Testing

Treatments: Genetic: Multigene pharmacogenomics test

Study type: Interventional

Funder types: Other

Identifiers

NCT05091879

2020-1103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

A multigene pharmacogenomics test will not be ordered for patients in this study arm, as is the standard of care.

Pharmacogenomics Testing

Experimental group

Description:

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.

Treatment:

Genetic: Multigene pharmacogenomics test