Virtual Gout Clinic

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790463
• Other study ID #: X121119002
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 2018

Study information

• Verified date: October 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1463
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Behavioral:
• Pharmacist-Led Intervention
Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Kaiser Permanente	Pasadena	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Kaiser Permanente, University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sUA < 6.0 mg/dl at 1 Year	Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year	12 months
Primary	Adherence to Medication	Adherence to prescribed medication	12 months