## Protocol Section
### Identification Module
**NCT ID:** NCT01568879

**Brief Title:** Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

**Official Title:** Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

#### Organization Study ID Info
**ID:** CN-11RGold-02-H
#### Organization
**Class:** OTHER
**Full Name:** Kaiser Permanente
### Status Module
#### Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Start Date
**Date:** 2012-01

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2012-04-02
**Type:** ESTIMATED
**Study First Submit Date:** 2012-03-28
**Study First Submit QC Date:** 2012-03-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kaiser Permanente

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Recurrent or Tophaceous Gout

**Keywords:**

- Recurrent gout

- Tophaceous gout

- Gout flares

- Arthritis

- Joint Diseases

- Rheumatic Diseases

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 104

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Gout Disease Management Program

**Label:** Gout Chronic Disease Management Program

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Control

**Label:** Usual Care

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Usual Care

**Description:** 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.

**Name:** Control

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Gout Chronic Disease Management Program

**Description:** 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.

**Name:** Gout Disease Management Program

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Serum Uric Acid Level

**Time Frame:** change from baseline at 6 months follow up

#### Secondary Outcomes

**Description:** Change in Serum Creatinine

**Measure:** Serum Creatinine

**Time Frame:** 0, 12, and 26 weeks

**Description:** Change in serum ALT (a measure of potential toxicity)

**Measure:** Serum Alanine Aminotransferase (ALT)

**Time Frame:** 0, 12, and 26 weeks

**Description:** Number of gout flares

**Measure:** Gout flares

**Time Frame:** 0, 12, and 26 weeks

### Eligibility Module

**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

**Maximum Age:** 80 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** All KPNC Facilities

**Country:** United States

**Facility:** Kaiser Permanente Northern California Medical Facilities

**State:** California

#### Overall Officials

**Official 1:**

**Affiliation:** Kaiser Permanente

**Name:** Robert Goldfien, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000070657

- Term: Crystal Arthropathies

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000011686

- Term: Purine-Pyrimidine Metabolism, Inborn Errors

- ID: D000008661

- Term: Metabolism, Inborn Errors

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M9177

- Name: Gout

- Relevance: HIGH

- As Found: Gout

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: HIGH

- As Found: Chronic Disease

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M630

- Name: Crystal Arthropathies

- Relevance: LOW

- As Found: Unknown

- ID: M11641

- Name: Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M14540

- Name: Purine-Pyrimidine Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006073

- Term: Gout

- ID: D000002908

- Term: Chronic Disease

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17277

- Name: Uric Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
