Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
Condition: Recurrent or Tophaceous Gout
MeSH terms: Gout; Chronic Disease
Study type: Interventional

Summary: 
      The aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based
      chronic disease management program compared to patients receiving usual care in achieving a
      target serum uric acid level in patients with recurrent gout.
    

Detailed description: 
      Gout is a chronic condition with intermittent symptoms and should be managed through an
      outcome-based disease management approach. Unlike other common chronic conditions, strategies
      for population management in gout patients have not been tested. The study will identify
      adult members of Kaiser Permanente (KP) Northern California with a diagnosis of gout and 3 or
      more outpatient or Emergency Department visits for gout over a 1-year period preceding study
      enrollment. These patients will be randomized to either an active management group, or to
      usual care. The participants will be enrolled and followed over a period of 26 weeks. The
      primary outcome to be measured will be the attainment and maintenance of a uric acid lowering
      regimen targeted to achieve serum uric acid level of 6.0 mg/dl or less. The treatment
      protocol will use standard treatment guidelines to lower and maintain uric acid levels to
      less than or equal to 6.0 mg/dl (or maximum doses of uric acid lowering medications) and
      provide patient education and dietary counseling. Monitoring and medication management will
      be carried out by a licensed clinical pharmacist under the supervision of an experienced
      rheumatologist. Control subjects will have regular monitoring of serum uric acid levels and
      will be provided with educational material and dietary counseling, but otherwise receive
      usual care. The demonstration that a chronic disease management approach to gout care can
      improve the health and reduce morbidity in patients with gout may illuminate a simple path
      towards improved quality of life and reduced morbidity in this growing population of
      patients.
    

Intervention name(s): Control; Gout Disease Management Program
Intervention type(s): Other; Other
Intervention description(s): The control group will receive care from their primary care physician that reflects the actual current care received by KPNC patients, but will not receive any treatment recommendations from the study protocol. The control subject will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling.; The experimental group will utilize standard guidelines for the initiation of uric acid lowering treatments, and approved medications. The study protocol treatments include medication management, dietary guidelines, and basic educational materials on gout and its management. No non-formulary medications or devices will be used. The experimental procedure to be tested is the use of a structured protocol to manage and monitor standard treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent gout; Tophaceous gout; Gout flares; Arthritis; Joint Diseases; Rheumatic Diseases