Clinical and Economic Implications of Genetic Testing for Warfarin Management

Active, not recruiting

Phase 4 Results N/A

Trial Description

The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.

Detailed Description

The overall goal of this project is to develop and assess the effectiveness and cost-effectiveness of strategies that use genetic testing in the management of anticoagulation among racially diverse hospitalized patients. The project has four specific aims.
Aim 1: To contribute patients initiating therapy at the University of Chicago Medical Center (UCMC) and affiliated hospitals to a genetic registry of a racially diverse set of patients undergoing warfarin therapy.
Aim 2: To perform a randomized trial to determine the efficacy, costs and cost-effectiveness of existing pharmacogenetic algorithms for the management of warfarin therapy among hospitalized patients of all races.
Aim 3: To develop clinical pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.
Aim 4: To perform a randomized trial to determine and compare the efficacy, costs and cost-effectiveness of existing clinical and non-racially tailored pharmacogenetic algorithms to racially tailored pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
    ARM 1: Kind: Experimental
    Label: Clinically Guided Cohort
    Description: Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
    ARM 2: Kind: Experimental
    Label: Pharmacogenetically Guided Cohort
    Description: Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: 1) Clinically Guided Cohort: where Estimated Effective Warfarin dosing calculations are based on clinical data algorithms and 2) Pharmacogenetically Guided Cohort: Experimental whereEstimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms. In both arms, Warfarin Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose. Patient will be evaluated for outcomes at 30 days and followed for 1 year.

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical outcomes and costs associated with the use of genetic testing will be compared to current standards of care and alternative management practices to assess the value of genotype-guided warfarin therapy algorithms for patients and payers.
Secondary Clinical outcomes: inpatient length of stay, supratherapeutic dosing, time within range, and the incidence of deep venous thrombosis (DVT), stroke, pulmonary embolus (PE), gastrointestinal bleeding (GI) and intracranial hemorrhage (ICH); direct costs of interest include: hospital costs, genetic costs, medication costs, laboratory costs, and total therapy costs in aggregate and broken down by payer.
Secondary Clinical outcomes: inpatient length of stay, supratherapeutic dosing, time within range, and the incidence of deep venous thrombosis (DVT), stroke, pulmonary embolus (PE), gastrointestinal bleeding (GI) and intracranial hemorrhage (ICH). one year Yes
Secondary Direct costs of interest include: hospital costs, genetic costs, medication costs, laboratory costs, and total therapy costs in aggregate and broken down by payer. 1 month after discharge No

Sponsors