Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

Recurrent or Tophaceous Gout Clinical Trial

Official title:

Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568879
• Other study ID #: CN-11RGold-02-H
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: March 4, 2015
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Gout
• Recurrent or Tophaceous Gout

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California Medical Facilities	All KPNC Facilities	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum Creatinine	Change in Serum Creatinine	0, 12, and 26 weeks	No
Secondary	Serum Alanine Aminotransferase (ALT)	Change in serum ALT (a measure of potential toxicity)	0, 12, and 26 weeks	No
Secondary	Gout flares	Number of gout flares	0, 12, and 26 weeks	No