CLinical Prediction Rule Score in Veterans

Withdrawn

• Conditions: Gout

• Registration Number: NCT01418781
• Lead Sponsor: jasvinder singh

Brief Summary

We will study whether the health care costs and health utilities differ in patients with gout and those without gout and whether they differ between those with more severe versus less severe gout

Detailed Description

The purpose of this project is to study the out-patient and inpatient utilization and costs associated with tophaceous gout (a classic form of treatment-failure gout), compare these costs to patients with non-tophaceous gout and evaluate health utilities associated with these gout states. The analyses will be conducted in a manner to support a burden of illness type of presentation / manuscript.

Study Questions

1. What are the VA health care costs (inpatient and outpatient) for patients with gout compared to those without gout?

2. Does health utility, as calculated by SF-6D, differ in patients with gout compared to patients without gout and between tophaceous and non-tophaceous gout?

3. What are the relationships between costs and health utility?

4. How does the burden of illness differ by subgroups of gout patients (costs and utilities)?

5. What are the VA health care costs for patients with tophaceous gout and are they higher than patients with non-tophaceous gout?

Inclusion criteria Patients with and without gout from the Veterans database described above will be included in the analyses for Study aims 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients

Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• participated in the survey
• Have SF-36 adn utilization data

Exclusion Criteria

• Absence of utilization and/or cost data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health care costs	Up to 5-year post-survey	Total of outpatient, inpatient and emergent care costs

Secondary Outcome Measures

Name	Time	Method
Health utility index, SF-6D	18-months	at 18-month post-survey
Activity limitation on Katz 6 ADL	18-months	Katz 6 ADL questions assess difficulty with doing 6 key activities, bathing, eating, toileting, walking, getting up and climbing stairs
Mortality	5-years	Up to 5-year post-survey
Health care utilization	1-year post-survey	Health care utilization as sum of outpatient, inpatient and emergent care utilization

Trial Locations

Locations (1)

Minneapolis VA Medical Center; 🇺🇸 Minneapolis, Minnesota, United States