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| Name | Class |
|---|---|
| University of Nebraska | OTHER |
| Kaiser Permanente | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants recruited in this arm will receive their usual care for gout as they normally would | |
| Intervention | Active Comparator | Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-Led Intervention | Behavioral | Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact |
| Measure | Description | Time Frame |
|---|---|---|
| sUA < 6.0 mg/dl at 1 Year | Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year | 12 months |
| Adherence to Medication | Adherence to prescribed medication | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30503879 | Derived | 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. |
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No, not permitted by data use agreements
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants recruited in this arm will receive their usual care for gout as they normally would |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants recruited in this arm will receive their usual care for gout as they normally would |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | sUA < 6.0 mg/dl at 1 Year | Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year | Posted | Count of Participants | Participants | 12 months |
|
2 year study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants recruited in this arm will receive their usual care for gout as they normally would |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxic epidermal necolysis (TENs) | Skin and subcutaneous tissue disorders | Systematic Assessment | Severe cutaneous reaction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Foster | UNIVERSITY OF ALABAMA AT BIRMINGHAM | 205-996-6086 | pjfoster@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2017 | Sep 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| Pasadena |
| California |
| 91101 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Serum urate, mean | Mean | Standard Deviation | mg/dl |
|
| Serum creatinine, mean | Mean | Standard Deviation | mg/dl |
|
| Allopurinol dose, mean | Mean | Standard Deviation | mg/day |
|
| Colchicine use | Count of Participants | Participants |
|
| Prescription NSAID use | Count of Participants | Participants |
|
| Glucocorticoid use | Count of Participants | Participants |
|
| Thiazide diuretic | Count of Participants | Participants |
|
| Loop diurectic | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| hypertension | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Adherence to Medication | Adherence to prescribed medication | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 782 |
| 1 |
| 782 |
| 0 |
| 782 |
| EG001 | 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 | 0 | 681 | 1 | 681 | 0 | 681 |
|
| Drug rash with eosinophilia and systemic symptoms (DRESS) | Skin and subcutaneous tissue disorders | Systematic Assessment | Severe cutaneous reaction |
|
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |