Clinical trial NCT06887452: Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
Official title: Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP) Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gout
Gouty Arthritis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-03-20
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized multicenter, parallel-group study that will compare a pharmacist-led / telehealth delivered intervention to usual care in gout management
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: flare occurrence
timeFrame: during year two
measure: serum urate at goal
timeFrame: at end of year one
Secondary outcomes:
measure: Veterans RAND 12 (VR-12)
timeFrame: Baseline visit, Months 6, 12, 18, and 24
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline visit, Months 6, 12, 18, and 24
measure: Gout-related patient global assessment
timeFrame: Baseline visit, Months 6, 12, 18, and 24
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
state: Nebraska
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
name: Ted R. Mikuls
role: PRINCIPAL_INVESTIGATOR
References: