Virtual Gout Clinic

A Novel Centralized 'Virtual' Gout Clinic for Chronic Gout Management (NIAMS :CoRT)

The overarching goal of the investigators project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout care, and implement and evaluate such a strategy in a large, population-based healthcare setting. With the use of novel but readily-accessible technology, the investigators will examine the use of a novel, large-scale, and relatively low-cost pharmacy-based intervention, with the goal of optimizing urate lower therapy (ULT) in chronic gout treatment.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Behavioral: Pharmacist-Led Intervention

Detailed Description

Gout is a chronic and progressive form of arthritis occurring as a result of monosodium urate deposition in the joints and surrounding tissues. Despite its extremely well known pathogenesis and the availability of highly efficacious therapies, gout continues to lead to considerable morbidity and mortality due to poor management and limited therapeutic adherence. The investigators translational research study will address this deficit in evidence implementation.

The treatment of chronic gout is based primarily on the use of urate lower therapy (ULT) to reduce the frequency of, and eventually eliminate, acute flares in addition to reducing the risk of progressive joint destruction. There are currently four ULT agents approved for the treatment of gout in the United States (US) including probenecid (a uricosuric), pegloticase (a biologic therapy approved for treatment-refractory gout), allopurinol, and febuxostat. Available for more than 40 years, allopurinol remains the most frequently prescribed ULT, accounting for ~99% of all ULT prescriptions. Many early studies confirmed the robust urate lowering effect of allopurinol, a treatment also yielding ample improvements in long-term outcomes including a reduction in gouty flares. A recent 28-week randomized trial examining fixed dose daily allopurinol revealed a 34% reduction in serum urate concentrations vs. a decrease of 3-4% for those receiving placebo. There are factors that contribute to sub-optimal allopurinol administration and likely include, but are not limited to: 1) failure of prescribers to appropriately titrate allopurinol dose to achieve optimal serum urate target levels; 2) poor long term patient adherence to therapy; 3) drug intolerance, recognizing that this affects only a small proportion of patients; 4) limited data regarding the effectiveness of doses exceeding 300 mg/day; and 5) concerns regarding increased toxicity with higher doses, particularly in the context of chronic kidney disease (CKD).

To date, there have been no published studies examining the impact of a large scale intervention implemented to optimize allopurinol administration in gout. Intervention studies that have been done have universally involved small sample sizes and have been limited to single centers, substantially limiting the external validity of these efforts. The impact of these interventions, largely employing prescription audits and performance feedback to providers, have either gone unreported or have been quite modest in effect. Given the potential cost-effectiveness of allopurinol in gout treatment compared to alternative ULTs and the growing number of reports that have consistently characterized its everyday use as sub-optimal, interventions focused on improving and optimizing allopurinol administration in the context of 'real-life' gout care are urgently needed.

• Study Type: Interventional
• Enrollment (Actual): 1463
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Pasadena, California, United States, 91101
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least one prior International Classification of Disease (ICD) 9 code for gout (274.xx)
• Received a new prescription for allopurinol, defined as no prior allopurinol prescription in the preceding 12 months

Exclusion Criteria:

• No prior ICD9 code for gout (274.xx)
• Did not receive a new prescription for allopurinol, defined as no prior allopurinol prescription in the preceding 12 months

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
No Intervention: Usual Care; Participants recruited in this arm will receive their usual care for gout as they normally would
Active Comparator: Intervention; Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention	Behavioral: Pharmacist-Led Intervention; Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sUA < 6.0 mg/dl at 1 Year	Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year	12 months
Adherence to Medication	Adherence to prescribed medication	12 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Kaiser Permanente; University of Nebraska

Publications and helpful links

General Publications

• Mikuls TR, Cheetham TC, Levy GD, Rashid N, Kerimian A, Low KJ, Coburn BW, Redden DT, Saag KG, Foster PJ, Chen L, Curtis JR. Adherence and Outcomes with Urate-Lowering Therapy: A Site-Randomized Trial. Am J Med. 2019 Mar;132(3):354-361. doi: 10.1016/j.amjmed.2018.11.011. Epub 2018 Nov 29.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Allopurinol
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: X121119002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No, not permitted by data use agreements