Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT01568879

Collaborator

(none)

104

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent or Tophaceous Gout	Other: Control Other: Gout Disease Management Program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Serum Uric Acid Level [change from baseline at 6 months follow up]
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.

Secondary Outcome Measures

Serum Creatinine [0, 12, and 26 weeks]
Change in Serum Creatinine
Serum Alanine Aminotransferase (ALT) [0, 12, and 26 weeks]
Change in serum ALT (a measure of potential toxicity)
Gout flares [0, 12, and 26 weeks]
Number of gout flares