Preemptive Pharmacogenomics Testing Among Geriatric Patients

Polypharmacy Clinical Trial

Official title:

Implementation and Evaluation of Preemptive Pharmacogenomics Testing in an Aging Population

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05091879
• Other study ID #: 2020-1103
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Polypharmacy

Intervention

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

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

References & Publications (12)

Bain KT, Matos A, Knowlton CH, McGain D. Genetic variants and interactions from a pharmacist-led pharmacogenomics service for PACE. Pharmacogenomics. 2019 Jul;20(10):709-718. doi: 10.2217/pgs-2019-0047. Epub 2019 Aug 1. — View Citation

Bain KT, Schwartz EJ, Knowlton OV, Knowlton CH, Turgeon J. Implementation of a pharmacist-led pharmacogenomics service for the Program of All-Inclusive Care for the Elderly (PHARM-GENOME-PACE). J Am Pharm Assoc (2003). 2018 May-Jun;58(3):281-289.e1. doi: 10.1016/j.japh.2018.02.011. Epub 2018 Mar 27. — View Citation

Dong OM, Wheeler SB, Cruden G, Lee CR, Voora D, Dusetzina SB, Wiltshire T. Cost-Effectiveness of Multigene Pharmacogenetic Testing in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention. Value Health. 2020 Jan;23(1):61-73. doi: 10.1016/j.jval.2019.08.002. Epub 2019 Sep 25. — View Citation

Ellenbogen MI, Wang P, Overton HN, Fahim C, Park A, Bruhn WE, Carnahan JL, Linsky AM, Balogun SA, Makary MA. Frequency and Predictors of Polypharmacy in US Medicare Patients: A Cross-Sectional Analysis at the Patient and Physician Levels. Drugs Aging. 2020 Jan;37(1):57-65. doi: 10.1007/s40266-019-00726-0. — View Citation

Hicks JK, Bishop JR, Sangkuhl K, Muller DJ, Ji Y, Leckband SG, Leeder JS, Graham RL, Chiulli DL, LLerena A, Skaar TC, Scott SA, Stingl JC, Klein TE, Caudle KE, Gaedigk A; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective Serotonin Reuptake Inhibitors. Clin Pharmacol Ther. 2015 Aug;98(2):127-34. doi: 10.1002/cpt.147. Epub 2015 Jun 29. — View Citation

Hicks JK, Sangkuhl K, Swen JJ, Ellingrod VL, Muller DJ, Shimoda K, Bishop JR, Kharasch ED, Skaar TC, Gaedigk A, Dunnenberger HM, Klein TE, Caudle KE, Stingl JC. Clinical pharmacogenetics implementation consortium guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther. 2017 Jul;102(1):37-44. doi: 10.1002/cpt.597. Epub 2017 Feb 13. — View Citation

Mehta D, Uber R, Ingle T, Li C, Liu Z, Thakkar S, Ning B, Wu L, Yang J, Harris S, Zhou G, Xu J, Tong W, Lesko L, Fang H. Study of pharmacogenomic information in FDA-approved drug labeling to facilitate application of precision medicine. Drug Discov Today. 2020 May;25(5):813-820. doi: 10.1016/j.drudis.2020.01.023. Epub 2020 Feb 4. — View Citation

O'Donnell PH, Bush A, Spitz J, Danahey K, Saner D, Das S, Cox NJ, Ratain MJ. The 1200 patients project: creating a new medical model system for clinical implementation of pharmacogenomics. Clin Pharmacol Ther. 2012 Oct;92(4):446-9. doi: 10.1038/clpt.2012.117. Epub 2012 Aug 29. — View Citation

Ramsey LB, Johnson SG, Caudle KE, Haidar CE, Voora D, Wilke RA, Maxwell WD, McLeod HL, Krauss RM, Roden DM, Feng Q, Cooper-DeHoff RM, Gong L, Klein TE, Wadelius M, Niemi M. The clinical pharmacogenetics implementation consortium guideline for SLCO1B1 and simvastatin-induced myopathy: 2014 update. Clin Pharmacol Ther. 2014 Oct;96(4):423-8. doi: 10.1038/clpt.2014.125. Epub 2014 Jun 11. — View Citation

Rohrer Vitek CR, Abul-Husn NS, Connolly JJ, Hartzler AL, Kitchner T, Peterson JF, Rasmussen LV, Smith ME, Stallings S, Williams MS, Wolf WA, Prows CA. Healthcare provider education to support integration of pharmacogenomics in practice: the eMERGE Network experience. Pharmacogenomics. 2017 Jul;18(10):1013-1025. doi: 10.2217/pgs-2017-0038. Epub 2017 Jun 22. — View Citation

Scott SA, Sangkuhl K, Stein CM, Hulot JS, Mega JL, Roden DM, Klein TE, Sabatine MS, Johnson JA, Shuldiner AR; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium guidelines for CYP2C19 genotype and clopidogrel therapy: 2013 update. Clin Pharmacol Ther. 2013 Sep;94(3):317-23. doi: 10.1038/clpt.2013.105. Epub 2013 May 22. — View Citation

Yang Y, Botton MR, Scott ER, Scott SA. Sequencing the CYP2D6 gene: from variant allele discovery to clinical pharmacogenetic testing. Pharmacogenomics. 2017 May;18(7):673-685. doi: 10.2217/pgs-2017-0033. Epub 2017 May 4. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Costs of clinical care	The total healthcare costs of patients.	Date of test results reported to end of study, up to 5 years
Secondary	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
Secondary	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

External Links

•   Clinical Pharmacogenetic Implementation Consortium (CPIC) guidelines.
•   FDA Center for Drug Evaluation and Research Table of pharmacogenomic biomarkers in drug labeling.