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| ID | Type | Description | Link |
|---|---|---|---|
| CX002995 | Other Grant/Funding Number | VA CSR&D |
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This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.
This project will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and serum urate goal achievement in 310 U.S. Veterans with gout enrolled from five VA medical centers. The project will quantify the effects of the intervention on patient-reported outcomes (improvements in health-related quality of life, pain interference, and participant global assessment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist-Led | Experimental | Veterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment. |
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| Usual care | No Intervention | Veterans will receive standard care from their primary care provider for the management of their gout. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-Led | Other | Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| flare occurrence | The occurrence of two or more flares during year 2. | during year two |
| serum urate at goal | Achievement of serum urate <6 mg/dL at end of year one. | at end of year one |
| Measure | Description | Time Frame |
|---|---|---|
| Veterans RAND 12 (VR-12) | Quality of life instrument to assess components of physical and mental health. The survey asks about a patient's views on their health. The information will keep track of how a patient feels and how well they are able to do their usual activities. Scores include ranking their health from excellent to poor, whether physical or emotional health or pain limits activities or accomplishments, whether their health interferes with social activities and lastly asks patients to compare their physical and emotional health to one year ago. The scales range from not-at-all through all the time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bridget Kramer | Contact | (402) 995-3206 | bridget.kramer@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ted R. Mikuls | Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE | Omaha | Nebraska | 68105-1850 | United States |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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Randomized multicenter, parallel-group study that will compare a pharmacist-led / telehealth delivered intervention to usual care in gout management
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| Baseline visit, Months 6, 12, 18, and 24 |
| Patient Reported Outcomes Measurement Information System (PROMIS) | Survey to assess pain on relevant aspects of a patient's life within the last 7 days. The survey asks whether or not pain interfered with enjoyment, concentration, outside-of-home tasks, and socialization. The scale is at a not at all (1) through very much (5). | Baseline visit, Months 6, 12, 18, and 24 |
| Gout-related patient global assessment | Participants will complete a rating scale on all the ways gout affects them on a 0-100 scale ranging from very well to very poor. | Baseline visit, Months 6, 12, 18, and 24 |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | United States |
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| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104-4551 | United States |
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| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148-0001 | United States |
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| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | United States |
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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 |