Pharmacogenomic Testing Of the Elderly To Reduce Morbidity (POETRY)

The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.

The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual's response to drugs is known as "Pharmacogenomics."

Study Overview

• Status: Unknown
• Conditions: Genetics of Drug Metabolism

• Study Type: Observational
• Enrollment (Anticipated): 280000

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Recruiting
    • Research & Cardiovascular Corp.
    • Contact: Jose Vazquez Tanus, MD; Phone Number: 787-290-8585; Email: vazqueztanus@me.com
    • Principal Investigator: Jose Vazquez Tanus, MD
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Recruiting
      • Core Insitute
      • Contact: Eric Feldman, MD; Phone Number: 623-537-5695; Email: eric.feldman@thecoreinstitute.com
      • Principal Investigator: Eric Feldman, MD
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • LifeSpan Institute
      • Contact: Steven A Brody, M.D., Ph.D.; Phone Number: 858-344-5020; Email: sbrodymd@lifespan-md.com
      • Principal Investigator: Steven A Brody, M.D., Ph.D.
    • Palm Springs, California, United States, 92262
      • Recruiting
      • The International Heart & Lung Institute Center for Restorative Medicine
      • Contact: Steven Gundry, MD; Phone Number: 760-323-5553; Email: DocSRG@aol.com
      • Principal Investigator: Steven Gundry, MD
  • Florida
    • Pembroke Pines, Florida, United States, 33026
      • Recruiting
      • Research Physicians Network Alliance
      • Contact: Perry Krichmar, MD; Phone Number: 954-237-6286; Email: pkrichmar@rpna.net
      • Principal Investigator: Perry Krichmar, MD
    • Tallahassee, Florida, United States, 32308
      • Recruiting
      • Tallahassee Neurological Institute
      • Principal Investigator: Matthew Lawson, MD
      • Contact: Lutheria Hollis; Phone Number: 850-877-5115; Email: lhollis@tnc-neuro.com
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • Hypertension Institute
      • Contact: Mark Houston, MD; Phone Number: 615-512-1481; Email: boohouston@comcast.net
      • Principal Investigator: Mark C Houston, M.D.
  • Texas
    • Houston, Texas, United States, 77004
      • Recruiting
      • Diagnostic Clinic of Houston
      • Contact: Freemu Varghese, MD; Email: fvarghese@diagnosticclinic.com
      • Principal Investigator: Freemu Varghese, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects aged 65 and above or subjects aged 18 and above who have a disability will be eligible for inclusion in the study if they are receiving or are planned to receive at least one medication with a metabolic pathway linked to genetic variations ("target drug").

Description

Inclusion Criteria:

• Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
• Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
• Subject is able and willing to provide written informed consent
• Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
• Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug

Exclusion Criteria:

• Subject is currently hospitalized
• Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
• Subject is unable to provide an accurate history due to mental incapacity
• Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Meaningful Change in Drug Regimen	The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when: A genotype known to affect a drug the subject is taking is identified, and; The subject's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results		90 days
Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results		90 days
Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test	Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion	90 days
Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs		90 days
Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results		90 days
Number of target drug-related adverse events over the 90-day period prior to and following PGx testing		90 days
Emergency department visits over the 90-day periods prior to and following PGx testing		90 days
Hospitalizations over the 90-day period prior to and following receipt of PGx test results		90 days

Collaborators and Investigators

• Sponsor: General Genetics Corporation
• Collaborators: Syntactx
• Investigators: Principal Investigator: Bill Massey, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Pharmacogenomics; Adverse Drug Reactions
• Other Study ID Numbers: 201301