CLinical Prediction Rule Score in Veterans

Development of CLinical Prediction Rule Score in Veterans: A Study of Impact of Gout on Health Care Utilization and Costs

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

Study Overview

• Status: Withdrawn
• Conditions: 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55123
      • Minneapolis VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with and without gout from the Veterans Upper Midwest SF-36 survey database will be included in the analyses for Study questions 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Absence of utilization and/or cost data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Gout; Patients with ICD-9 for gout
No Gout; Patients withOUT ICD-9 for gout
Tophaceous gout; Patients with ICD-9 for tophaceous gout
non-tophaceous gout; those with ICD-9 for gout other than the codes specific for tophaceous gout

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care costs	Total of outpatient, inpatient and emergent care costs	Up to 5-year post-survey

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: jasvinder singh
• Collaborators: Novartis; Takeda; Regeneron Pharmaceuticals; Birmingham, Alabama VA Medical Center
• Investigators: Principal Investigator: David Nelson, Minneapolis VAMC

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimated): August 17, 2011

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: gout; cost; utilization
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: MVAMC-3669A