CLinical Prediction Rule Score in Veterans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Minneapolis Veterans Affairs Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Takeda
Novartis
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
jasvinder singh, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01418781
First received: August 15, 2011
Last updated: April 23, 2012
Last verified: April 2012

August 15, 2011
April 23, 2012
January 2008
December 2013   (final data collection date for primary outcome measure)
Health care costs [ Time Frame: Up to 5-year post-survey ] [ Designated as safety issue: No ]
Total of outpatient, inpatient and emergent care costs
Health care costs [ Time Frame: 1-year post-survey ] [ Designated as safety issue: No ]
Total of outpatient, inpatient and emergent care costs
Complete list of historical versions of study NCT01418781 on ClinicalTrials.gov Archive Site
  • Health utility index, SF-6D [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    at 18-month post-survey
  • Health care utilization [ Time Frame: 1-year post-survey ] [ Designated as safety issue: No ]
    Health care utilization as sum of outpatient, inpatient and emergent care utilization
  • Activity limitation on Katz 6 ADL [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Katz 6 ADL questions assess difficulty with doing 6 key activities, bathing, eating, toileting, walking, getting up and climbing stairs
  • Mortality [ Time Frame: 5-years ] [ Designated as safety issue: No ]
    Up to 5-year post-survey
  • Health utility index [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Health-related quality of life was assessed from the cross-sectional Sf-36 for veterans (SF-36V) survey which was performed for the cohort who had 1 or more VA visit in the 18-months prior to the survey. We will calculate the Health utility index by calculating SF-6D from the SF-36 subscale scores.
  • Health care utilization [ Time Frame: 1-year post-survey ] [ Designated as safety issue: No ]
    Health care utilizationa as sum of outpatient, inpatient and emergent care utilization
Not Provided
Not Provided
 
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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Gout
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70000
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of utilization and/or cost data
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01418781
MVAMC-3669A
No
jasvinder singh, Minneapolis Veterans Affairs Medical Center
jasvinder singh
  • Department of Veterans Affairs
  • Takeda
  • Novartis
  • Regeneron Pharmaceuticals
Principal Investigator: David Nelson Minneapolis VAMC
Minneapolis Veterans Affairs Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP