Reduction of Adverse Drug Events and Readmissions

NCT02738047 | Recruiting DMC

• 1 other identifier: 10202016
• Study Type: observational
• Target: 280,000
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

Conditions

Pharmacogenomic Testing for Medication Management

Outcome Measures

Primary Outcomes (1)

• Radar, Pharmocogenomic

  The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each patient when: 1. A genotype known to affect a drug the patient is taking is identified, \*and\* 2. The patient's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation. Change in drug dose, substitution, or discontinuation among patients with an identified genotype known to affect a drug the patient is taking as directed. This will be assessed by a quantitative survey.

  The period of enrollment is anticipated to be 36 months with a 120- day follow-up period, for total study duration of approximately 40 months from first patient enrolled to completion of follow-up on the last patient in.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are under treatment with several drugs with any of the sequences of biochemical reactions, catalyzed by enzymes, known to be influenced by genetic variation in a patient population.

You may qualify if:

• Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them.
• Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days ("index PGx test assessment");
• Patient was receiving at least one medication known to be associated with allelic variation at the time of the ("index PGx test assessment"), including over-the- counter medications;
• Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment, or has experienced inadequate efficacy from a target drug.

You may not qualify if:

• Patients will be excluded from the Study if any of the following criteria apply:
• Patient is currently hospitalized;
• Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
• Patient is unable to provide an accurate history due to mental Incapacity;
• Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.

Sponsors & Collaborators

• ClinLogic LLC: lead

Study Sites (1)

MD@Home

York, Pennsylvania, 17402, United States

RECRUITING

Study Officials

• Haleh Farzanmehr, MD

  GXL

  PRINCIPAL INVESTIGATOR

• Haleh Farzanmehr, MD

  GXL

  STUDY DIRECTOR

Central Study Contacts

Diana Messir

CONTACT

239-908-0412; Diana@integritycro.com

Diana M Messir

CONTACT

239-908-0412; Diana.M@Radar-PGxStudy.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 120 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 14, 2016
• Study Start: March 15, 2019
• Primary Completion: March 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2023-12

Locations

US (1)