Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout (Pham-UP)

VA Office of Research and Development

Status: Begins enrollment this month

Conditions: Gouty Arthritis; Gout

Treatments: Other: Pharmacist-Led

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06887452

IMMA-005-24F

CX002995 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Pharmacist-Led

Experimental group

Description:

Veterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment.

Treatment:

Other: Pharmacist-Led

Usual care

No Intervention group

Description:

Veterans will receive standard care from their primary care provider for the management of their gout.