Clinical and Economic Implications of Genetic Testing for Warfarin Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management

Conditions
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Blood Coagulation Disorders

Intervention / Treatment
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* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: warfarin-naive patients ages 18 and older are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation Exclusion Criteria: patients who are not warfarin-naive 17 years of age or younger

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinically Guided Cohort<br>Estimated Effective Warfarin dosing calculations are based on clinical data algorithms | Drug: Warfarin<br>* Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.<br>* Other names: Coumadin;|
| Experimental: Pharmacogenetically Guided Cohort<br>Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms. | Drug: Warfarin<br>* Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.<br>* Other names: Coumadin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient Length of Stay | Inpatient length of stay | during hospital stay, up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supratherapeutic Dosing | International Normalized Ratio | during hospital stay, up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coumadine, genotype, genes, Warfarin