Virtual Gout Clinic
Primary Purpose
Gout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist-Led Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Gout focused on measuring Allopurinol
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- Kaiser Permanente
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual Care
Intervention
Arm Description
Participants recruited in this arm will receive their usual care for gout as they normally would
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Outcomes
Primary Outcome Measures
sUA < 6.0 mg/dl at 1 Year
Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year
Adherence to Medication
Adherence to prescribed medication
Secondary Outcome Measures
Full Information
NCT ID
NCT02790463
First Posted
May 31, 2016
Last Updated
October 21, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
University of Nebraska, Kaiser Permanente
1. Study Identification
Unique Protocol Identification Number
NCT02790463
Brief Title
Virtual Gout Clinic
Official Title
A Novel Centralized 'Virtual' Gout Clinic for Chronic Gout Management (NIAMS :CoRT)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of Nebraska, Kaiser Permanente
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
Allopurinol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1463 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants recruited in this arm will receive their usual care for gout as they normally would
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist-Led Intervention
Intervention Description
Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
Primary Outcome Measure Information:
Title
sUA < 6.0 mg/dl at 1 Year
Description
Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year
Time Frame
12 months
Title
Adherence to Medication
Description
Adherence to prescribed medication
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Kaiser Permanente
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No, not permitted by data use agreements
Citations:
PubMed Identifier
30503879
Citation
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.
Results Reference
derived
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Virtual Gout Clinic
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