Clinical trial NCT01568879: Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
Official title: Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent or Tophaceous Gout
Keywords: Recurrent gout
Tophaceous gout
Gout flares
Arthritis
Joint Diseases
Rheumatic Diseases
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Three or more outpatient/ED visits in a 24-month period prior to selection for study with one of these primary visit diagnoses:

* Gouty arthropathy
* Gout, unspecified
* Gout with other specified manifestations
* Tophaceous gout of ear (274.81) or other sites
* Gouty nephropathy

At least 2 years of continuous Kaiser Foundation Hospital Plan membership

Baseline uric acid level above 7.0mg/dl

Exclusion Criteria:

* Current cancer diagnosis with active treatment
* End stage renal disease
* Pregnant or lactating
* Patients with a diagnosis of dementia
* Terminally ill patients

Primary outcomes:
measure: Serum Uric Acid Level
timeFrame: change from baseline at 6 months follow up
Secondary outcomes:
measure: Serum Creatinine
timeFrame: 0, 12, and 26 weeks
measure: Serum Alanine Aminotransferase (ALT)
timeFrame: 0, 12, and 26 weeks
measure: Gout flares
timeFrame: 0, 12, and 26 weeks
Other outcomes:
Locations:
city: All KPNC Facilities
country: United States
facility: Kaiser Permanente Northern California Medical Facilities
state: California
Study officials:
affiliation: Kaiser Permanente
name: Robert Goldfien, MD
role: PRINCIPAL_INVESTIGATOR
References: