Clinical trial NCT01418781: CLinical Prediction Rule Score in Veterans
Official title: Development of CLinical Prediction Rule Score in Veterans: A Study of Impact of Gout on Health Care Utilization and Costs
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gout
Keywords: gout
cost
utilization
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Birmingham, Alabama VA Medical Center
name: Takeda
name: Novartis
name: Regeneron Pharmaceuticals
First posted: 2011-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Absence of utilization and/or cost data

Primary outcomes:
measure: Health care costs
timeFrame: Up to 5-year post-survey
Secondary outcomes:
measure: Health utility index, SF-6D
timeFrame: 18-months
measure: Health care utilization
timeFrame: 1-year post-survey
measure: Activity limitation on Katz 6 ADL
timeFrame: 18-months
measure: Mortality
timeFrame: 5-years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis VAMC
name: David Nelson
role: PRINCIPAL_INVESTIGATOR
References: