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Virtual Gout Clinic

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ClinicalTrials.gov Identifier: NCT02790463
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : October 30, 2018
Sponsor:
Collaborators:
University of Nebraska
Kaiser Permanente
Information provided by (Responsible Party):
Jeff Curtis, MD, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Gout Behavioral: Pharmacist-Led Intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Centralized 'Virtual' Gout Clinic for Chronic Gout Management (NIAMS :CoRT)
Study Start Date : January 2013
Actual Primary Completion Date : September 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

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




Primary Outcome Measures :
  1. Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year [ Time Frame: 12 months ]
  2. Adherence to medication [ Time Frame: 12 months ]
    Adherence to prescribed medication



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790463


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Kaiser Permanente
Pasadena, California, United States, 91101
Sponsors and Collaborators
University of Alabama at Birmingham
University of Nebraska
Kaiser Permanente

Responsible Party: Jeff Curtis, MD, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02790463     History of Changes
Other Study ID Numbers: X121119002
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No, not permitted by data use agreements

Keywords provided by Jeff Curtis, MD, University of Alabama at Birmingham:
Allopurinol

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases