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
Singh, Jasvinder A; Ramachandaran, Rekha (2016) Does rural residence impact total ankle arthroplasty utilization and outcomes? Clin Rheumatol 35:381-6
Saddekni, Michael B; Saag, Kenneth G; Dudenbostel, Tanja et al. (2016) The effects of urate lowering therapy on inflammation, endothelial function, and blood pressure (SURPHER) study design and rationale. Contemp Clin Trials 50:238-44
Coburn, Brian W; Cheetham, T Craig; Rashid, Nazia et al. (2016) Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study. Contemp Clin Trials 50:106-15
Singh, Jasvinder A; Yu, Shaohua (2016) Gout-related inpatient utilization: a study of predictors of outcomes and time trends. Arthritis Res Ther 18:57
Singh, Jasvinder A; Ramachandran, Rekha (2016) Time trends in total ankle arthroplasty in the USA: a study of the National Inpatient Sample. Clin Rheumatol 35:239-45
Reynolds, Richard J; Vazquez, Ana I; Srinivasasainagendra, Vinodh et al. (2016) Serum urate gene associations with incident gout, measured in the Framingham Heart Study, are modified by renal disease and not by body mass index. Rheumatol Int 36:263-70
Singh, Jasvinder A; Yu, Shaohua (2016) Utilization due to chronic obstructive pulmonary disease and its predictors: a study using the U.S. National Emergency Department Sample (NEDS). Respir Res 17:1
Singh, Jasvinder A; Yu, Shaohua (2016) Time Trends, Predictors, and Outcome of Emergency Department Use for Gout: A Nationwide US Study. J Rheumatol 43:1581-8
Singh, Jasvinder A; Qu, Haiyan; Yazdany, Jinoos et al. (2015) Barriers to Medication Decision Making in Women with Lupus Nephritis: A Formative Study using Nominal Group Technique. J Rheumatol 42:1616-23
Singh, Jasvinder A; Ramachandran, Rekha (2015) Does hospital volume predict outcomes and complications after total shoulder arthroplasty in the US? Arthritis Care Res (Hoboken) 67:885-90

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