Pharmacogenomic Testing, Polypharmacy
Conditions
Keywords
pharmacogenomics, pharmacogenetics, Medicare, geriatric, multigene, polypharmacy
Brief summary
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.
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.
Interventions
GENETICMultigene pharmacogenomics test
This multigene pharmacogenomics test will report genetic variation for genes that have Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pharmacogenomic results returned in patients' health records | 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
| Measure | Time frame | Description |
|---|---|---|
| Composite of changes to medication therapy | 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. |
| Costs of clinical care | Date of test results reported to end of study, up to 5 years | The total healthcare costs of patients. |
| Medical costs of care | 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. |
| Pharmacy costs of care | 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.). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRyley Uber, Pharm.D.
Geisinger Clinic
Outcome results
None listed