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Virtual Gout Clinic

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02790463
Enrollment
1463
Registered
2016-06-03
Start date
2013-01-31
Completion date
2018-10-31
Last updated
2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

Allopurinol

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.

Interventions

BEHAVIORALPharmacist-Led Intervention

Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact

Sponsors

University of Nebraska
CollaboratorOTHER
Kaiser Permanente
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
sUA < 6.0 mg/dl at 1 Year12 monthsAchievement of serum uric acid (sUA) \< 6.0 mg/dl at 1 year
Adherence to Medication12 monthsAdherence to prescribed medication

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual Care
Participants recruited in this arm will receive their usual care for gout as they normally would
782
Intervention
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
681
Total1,463

Baseline characteristics

CharacteristicInterventionTotalUsual Care
Age, Continuous58.6 Years
STANDARD_DEVIATION 14.2
58.3 Years
STANDARD_DEVIATION 14.3
58.0 Years
STANDARD_DEVIATION 14.4
Allopurinol dose, mean190 mg/day
STANDARD_DEVIATION 98
189 mg/day
STANDARD_DEVIATION 100
188 mg/day
STANDARD_DEVIATION 101
Body Mass Index31.5 kg/m2
STANDARD_DEVIATION 7.6
31.5 kg/m2
STANDARD_DEVIATION 7
31.5 kg/m2
STANDARD_DEVIATION 6.5
Colchicine use375 Participants794 Participants419 Participants
Diabetes mellitus157 Participants327 Participants170 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
175 Participants357 Participants182 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
506 Participants1106 Participants600 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Glucocorticoid use251 Participants544 Participants293 Participants
hypertension407 Participants859 Participants452 Participants
Loop diurectic47 Participants115 Participants68 Participants
Prescription NSAID use350 Participants735 Participants385 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants6 Participants3 Participants
Race (NIH/OMB)
Asian
135 Participants338 Participants203 Participants
Race (NIH/OMB)
Black or African American
77 Participants186 Participants109 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
31 Participants69 Participants38 Participants
Race (NIH/OMB)
Unknown or Not Reported
308 Participants604 Participants296 Participants
Race (NIH/OMB)
White
127 Participants260 Participants133 Participants
Region of Enrollment
United States
681 Participants1463 Participants782 Participants
Serum creatinine, mean1.16 mg/dl
STANDARD_DEVIATION 0.35
1.16 mg/dl
STANDARD_DEVIATION 0.35
1.16 mg/dl
STANDARD_DEVIATION 0.35
Serum urate, mean8.4 mg/dl
STANDARD_DEVIATION 1.6
8.4 mg/dl
STANDARD_DEVIATION 1.6
8.4 mg/dl
STANDARD_DEVIATION 1.6
Sex: Female, Male
Female
134 Participants269 Participants135 Participants
Sex: Female, Male
Male
547 Participants1194 Participants647 Participants
Thiazide diuretic80 Participants151 Participants71 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 7820 / 681
other
Total, other adverse events
0 / 7820 / 681
serious
Total, serious adverse events
1 / 7821 / 681

Outcome results

Primary

Adherence to Medication

Adherence to prescribed medication

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareAdherence to Medication250 Participants
InterventionAdherence to Medication341 Participants
Primary

sUA < 6.0 mg/dl at 1 Year

Achievement of serum uric acid (sUA) \< 6.0 mg/dl at 1 year

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CaresUA < 6.0 mg/dl at 1 Year117 Participants
InterventionsUA < 6.0 mg/dl at 1 Year204 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026