While there is strong evidence that ULTs are efficacious when used appropriately, their use in gout is too often characterized by poor quality of care and suboptimal patient outcomes. For that reason, a majority of gout patients receiving ULT fail to reach serum urate concentrations <6.0 mg/dl, a threshold associated with mproved outcomes. Although approved at daily doses as high as 800 mg per day, the modal daily dose of allopurinol (accounting for more than 95% of all ULT prescriptions) is 300 mg. Taken together, these data suggest that the current paradigm for gout treatment fails most patients and that novel approaches to health care delivery in chronic gout are needed. We propose a Type 2 translational research project aimed at adopting best practices for the management of gout in a community setting. This project fulfills the definition of Type 2 translational research, which is described by the Institute of Medicine (IOM) as 'research moving discovery from the bedside to community practice'. The IOM has defined deficiencies in medical care as the "quality chasm", and we have highlighted that a quality chasm in gout exists. The overarching goal of our project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout care, and implement and evaluate such a strategy in a large, population-based healthcare setting. With the use of novel and readily-accessible technology, we will examine the use of a novel, large-scale, and relatively low-cost pharmacy-based intervention, with the goal of optimizing ULT in chronic gout treatment.
The Specific Aims of our proposal are to: SA1. Using a rigorous randomized controlled study design, compare the effectiveness of a novel pharmacy-based Centralized "virtual" Gout Clinic (CGC) that incorporates protocol-driven care with usual care in the treatment of chronic gout. SA2. Compare adherence to allopurinol administered through the CGC with administration,in usual care. We hypothesize that a novel CGC incorporating protocol-driven care with the administration of allopurinol in chronic gout will be significantly more effective and will be associated with greater treatment adherence than usual care.

Public Health Relevance

We will examine the effectiveness of a highly novel Centralized Gout Clinic (CGC) in chronic gout management compared to usual care. Working with a large national healthcare system. Kaiser Permanente of Southern California, the CGC will be administered by a centralized pharmacy with patient communications facilitated through the use of an Interactive Voice Response System (IVRS). Given the 'real-life'context in which this study will be conducted, we anticipate that our findings will be highly generalizable and readily portable for translation into other patient populations to optimize gout management and long-term outcomes related to hyperuricemia.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Specialized Center (P50)
Project #
5P50AR060772-02
Application #
8525348
Study Section
Special Emphasis Panel (ZAR1-KM)
Project Start
Project End
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
2
Fiscal Year
2013
Total Cost
$432,400
Indirect Cost
$36,438
Name
University of Alabama Birmingham
Department
Type
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Taylor, William J; Redden, David; Dalbeth, Nicola et al. (2014) Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout. J Rheumatol 41:574-80
Kirwan, John R; Boers, Maarten; Hewlett, Sarah et al. (2014) Updating the OMERACT filter: core areas as a basis for defining core outcome sets. J Rheumatol 41:994-9
Stamp, Lisa K; Merriman, Tony R; Barclay, Murray L et al. (2014) Impaired response or insufficient dosage? Examining the potential causes of "inadequate response" to allopurinol in the treatment of gout. Semin Arthritis Rheum 44:170-4
(2014) Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 384:1005-70
Singh, Jasvinder A; Lewallen, David G (2014) Time trends in the characteristics of patients undergoing primary total knee arthroplasty. Arthritis Care Res (Hoboken) 66:897-906
Dalbeth, Nicola; Zhong, Cathy S; Grainger, Rebecca et al. (2014) Outcome measures in acute gout: a systematic literature review. J Rheumatol 41:558-68
Sattui, Sebastian E; Singh, Jasvinder A; Gaffo, Angelo L (2014) Comorbidities in patients with crystal diseases and hyperuricemia. Rheum Dis Clin North Am 40:251-78
Singh, Jasvinder A (2014) Facilitators and barriers to adherence to urate-lowering therapy in African-Americans with gout: a qualitative study. Arthritis Res Ther 16:R82
Singh, Jasvinder A (2014) The impact of gout on patient's lives: a study of African-American and Caucasian men and women with gout. Arthritis Res Ther 16:R132
Singh, Jasvinder A; Taylor, William J; Dalbeth, Nicola et al. (2014) OMERACT endorsement of measures of outcome for studies of acute gout. J Rheumatol 41:569-73

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