Preemptive Pharmacogenomics Testing Among Geriatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation and Evaluation of Preemptive Pharmacogenomics Testing in an Aging Population

Conditions
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Polypharmacy, Pharmacogenomic Testing

Intervention / Treatment
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* Genetic: Multigene pharmacogenomics test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>A multigene pharmacogenomics test will not be ordered for patients in this study arm, as is the standard of care. | |
| Experimental: Pharmacogenomics Testing<br>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<br>* This multigene pharmacogenomics test will report genetic variation for genes that have Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pharmacogenomic results returned in patients' health records | 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 | 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 | 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 | 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 | The total healthcare costs of patients. | Date of test results reported to end of study, up to 5 years | 
| Medical costs of care | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacogenomics, pharmacogenetics, Medicare, geriatric, multigene, polypharmacy