Gout
Conditions
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
Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sUA < 6.0 mg/dl at 1 Year | 12 months | Achievement of serum uric acid (sUA) \< 6.0 mg/dl at 1 year |
| Adherence to Medication | 12 months | Adherence to prescribed medication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 1,463 |
Baseline characteristics
| Characteristic | Intervention | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 58.6 Years STANDARD_DEVIATION 14.2 | 58.3 Years STANDARD_DEVIATION 14.3 | 58.0 Years STANDARD_DEVIATION 14.4 |
| Allopurinol dose, mean | 190 mg/day STANDARD_DEVIATION 98 | 189 mg/day STANDARD_DEVIATION 100 | 188 mg/day STANDARD_DEVIATION 101 |
| Body Mass Index | 31.5 kg/m2 STANDARD_DEVIATION 7.6 | 31.5 kg/m2 STANDARD_DEVIATION 7 | 31.5 kg/m2 STANDARD_DEVIATION 6.5 |
| Colchicine use | 375 Participants | 794 Participants | 419 Participants |
| Diabetes mellitus | 157 Participants | 327 Participants | 170 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 175 Participants | 357 Participants | 182 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 506 Participants | 1106 Participants | 600 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Glucocorticoid use | 251 Participants | 544 Participants | 293 Participants |
| hypertension | 407 Participants | 859 Participants | 452 Participants |
| Loop diurectic | 47 Participants | 115 Participants | 68 Participants |
| Prescription NSAID use | 350 Participants | 735 Participants | 385 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 135 Participants | 338 Participants | 203 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 186 Participants | 109 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 31 Participants | 69 Participants | 38 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 308 Participants | 604 Participants | 296 Participants |
| Race (NIH/OMB) White | 127 Participants | 260 Participants | 133 Participants |
| Region of Enrollment United States | 681 Participants | 1463 Participants | 782 Participants |
| Serum creatinine, mean | 1.16 mg/dl STANDARD_DEVIATION 0.35 | 1.16 mg/dl STANDARD_DEVIATION 0.35 | 1.16 mg/dl STANDARD_DEVIATION 0.35 |
| Serum urate, mean | 8.4 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 Participants | 269 Participants | 135 Participants |
| Sex: Female, Male Male | 547 Participants | 1194 Participants | 647 Participants |
| Thiazide diuretic | 80 Participants | 151 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 782 | 0 / 681 |
| other Total, other adverse events | 0 / 782 | 0 / 681 |
| serious Total, serious adverse events | 1 / 782 | 1 / 681 |
Outcome results
Adherence to Medication
Adherence to prescribed medication
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Adherence to Medication | 250 Participants |
| Intervention | Adherence to Medication | 341 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | sUA < 6.0 mg/dl at 1 Year | 117 Participants |
| Intervention | sUA < 6.0 mg/dl at 1 Year | 204 Participants |