Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

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.

Study Overview

• Status: Completed
• Conditions: Recurrent or Tophaceous Gout
• Intervention / Treatment: Other: Gout Disease Management Program; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • All KPNC Facilities, California, United States
      • Kaiser Permanente Northern California Medical Facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Other: Control; 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.
Experimental: Gout Chronic Disease Management Program	Other: Gout Disease Management Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Uric Acid Level	attainment and maintenance of a serum uric acid level of 6.0 mg/dl or less. The outcome will be considered positive if that level is attained and the 6 month follow up value remains at the target level.	change from baseline at 6 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Creatinine	Change in Serum Creatinine	0, 12, and 26 weeks
Serum Alanine Aminotransferase (ALT)	Change in serum ALT (a measure of potential toxicity)	0, 12, and 26 weeks
Gout flares	Number of gout flares	0, 12, and 26 weeks

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Robert Goldfien, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Arthritis; Joint Diseases; Rheumatic Diseases; Recurrent gout; Tophaceous gout; Gout flares
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Chronic Disease; Gout
• Other Study ID Numbers: CN-11RGold-02-H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No