Preemptive Pharmacogenomics Testing Among Geriatric Patients

NCT05091879 | Active Not Recruiting

• 1 other identifier: 2020-1103
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy; Pharmacogenomic Testing

Keywords

pharmacogenomics; pharmacogenetics; Medicare; geriatric; multigene; polypharmacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Composite of changes to medication therapy

  Date of test results reported to end of study, up to 5 years

• Costs of clinical care

  Date of test results reported to end of study, up to 5 years

• Medical costs of care

  Date of test results reported to end of study, up to 5 years

• Pharmacy costs of care

  Date of test results reported to end of study, up to 5 years

Study Arms (2)

Standard of Care

NO INTERVENTION

A multigene pharmacogenomics test will not be ordered for patients in this study arm, as is the standard of care.

Pharmacogenomics Testing

EXPERIMENTAL

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

Interventions

Multigene pharmacogenomics test GENETIC

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

Pharmacogenomics Testing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Follows at a Geisinger 65 Forward clinic location
• Active prescriptions for 5 or more medications

You may not qualify if:

• Liver transplantation
• Allogenic hematopoetic stem cell transplantation
• Previously enrolled in the Electronic Medical Records and Genomics (eMERGE) pharmacogenomics cohort

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Related Publications (12)

• 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.

  PMID: 32032705 BACKGROUND

• 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.

  PMID: 25974703 BACKGROUND

• 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.

  PMID: 27997040 BACKGROUND

• 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.

  PMID: 23698643 BACKGROUND

• 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.

  PMID: 24918167 BACKGROUND

• 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.

  PMID: 31952675 BACKGROUND

• 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.

  PMID: 31782129 BACKGROUND

• 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.

  PMID: 28470112 BACKGROUND

• 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.

  PMID: 28639489 BACKGROUND

• 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.

  PMID: 29602745 BACKGROUND

• 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.

  PMID: 22929923 BACKGROUND

• 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.

  PMID: 31368837 BACKGROUND

Related Links

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

Study Officials

• Ryley Uber, Pharm.D.

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 25, 2021
• Study Start: March 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)