Clinical trial NCT05091879: Preemptive Pharmacogenomics Testing Among Geriatric Patients
Official title: Implementation and Evaluation of Preemptive Pharmacogenomics Testing in an Aging Population
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Polypharmacy
Pharmacogenomic Testing
Keywords: pharmacogenomics
pharmacogenetics
Medicare
geriatric
multigene
polypharmacy
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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, healthcare utilization, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of pharmacogenomic results returned in patients' health records
timeFrame: Date of blood draw to test results reported in medical record, up to 1 month
Secondary outcomes:
measure: Composite of changes to medication therapy
timeFrame: Date of test results reported to end of study, up to 5 years
measure: Number of hospitalizations
timeFrame: Date of test results reported to end of study, up to 5 years
measure: Number of ambulatory visits
timeFrame: Date of test results reported to end of study, up to 5 years
measure: Costs of clinical care
timeFrame: Date of test results reported to end of study, up to 5 years
measure: Medical costs of care
timeFrame: Date of test results reported to end of study, up to 5 years
measure: Pharmacy costs of care
timeFrame: Date of test results reported to end of study, up to 5 years
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Ryley Uber, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
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