Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout

Not Applicable

Not yet recruiting

• Conditions: Gout; Gouty Arthritis

• Registration Number: NCT06887452
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2026-03-01
• Primary Completion: 2029-03-01
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• US Veterans over the age of 18 years with physician-diagnosed
• Documented hyperuricemia (SU >6.8 mg/dL)
• Satisfy ACR/EULAR gout classification criteria
• Report 1 or more flares in the prior 6 months
• Receipt of a new ULT prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria

Exclusion Criteria

• Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)
• Patients with a rheumatology encounter within the prior 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
flare occurrence	during year two	The occurrence of two or more flares during year 2.
serum urate at goal	at end of year one	Achievement of serum urate \<6 mg/dL at end of year one.

Secondary Outcome Measures

Name	Time	Method
Veterans RAND 12 (VR-12)	Baseline visit, Months 6, 12, 18, and 24	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.
Patient Reported Outcomes Measurement Information System (PROMIS)	Baseline visit, Months 6, 12, 18, and 24	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).
Gout-related patient global assessment	Baseline visit, Months 6, 12, 18, and 24	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.

Trial Locations

Locations (5)

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE; 🇺🇸 Omaha, Nebraska, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States

VA Salt Lake City Health Care System, Salt Lake City, UT; 🇺🇸 Salt Lake City, Utah, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States