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Completed

NCT Number: NCT05091879

Preemptive Pharmacogenomics Testing Among Geriatric Patients

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, and costs of care.

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Key information

Conditions

Polypharmacy Pharmacogenomic Testing

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multigene pharmacogenomics test

Genetic

This multigene pharmacogenomics test will report genetic variation for genes that have Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.).

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Implementation and Evaluation of Preemptive Pharmacogenomics Testing in an Aging Population

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2021
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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