Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP) Study

Gout is the most common form of inflammatory arthritis, affecting up to 6% of all U.S. Veterans. In addition to being ~50% more frequent in the VA than the general population, gout burden is overrepresented among older Veterans and in underrepresented racial/ethnic groups as well as Veterans residing in rural areas where access to subspecialty arthritis care is limited. Effective and safe urate-lowering therapy (ULT) allows for the marked reduction or even elimination of gout-related signs and symptoms by reducing hyperuricemia. Despite the broad availability of inexpensive and highly efficacious ULT, suboptimal management is prevalent in gout. ULT administration in gout is characterized in the VA Health Care System and beyond by ‘clinical inertia’ with recommended serum urate (sUA) monitoring and treatment escalation being uncommon. This suboptimal management leads to poor patient outcomes that include increased frequency and severity of flares, higher rates of chronic opioid use, greater healthcare utilization, and increased morbidity and mortality. In this application, we have proposed the pragmatic multicenter “Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP)” trial that will include 310 Veteran patients with gout enrolled from 5 VA medical centers. The total study duration will be 4 years, including a 2-year accrual period and 2 years of participant follow-up. The randomized and controlled Pharm-UP study will for the first time establish the clinical efficacy of a highly scalable, telehealth-delivered intervention in the Veterans Health Administration (VHA). Our central hypothesis is that protocolized gout management incorporating treat-to-target ULT led by trained VHA pharmacists and delivered using a decentralized telehealth approach will be superior to usual gout care. We plan to test our central hypothesis by pursuing two specific aims. In Aim 1, we will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and sUA goal achievement in U.S. Veterans with gout. Outcomes addressed in this aim represent the two top prioritized domains by an Outcomes Measures in Rheumatology (OMERACT) special interest group for inclusion in studies of chronic gout management and align with target sUA thresholds endorsed for clinical application by multiple international subspecialty societies. In Aim 2, we will enumerate the effects of a pharmacist-led telehealth- delivered intervention compared to usual care with respect to improvements in health-related quality of life, pain interference, and patient global assessment, all OMERACT-recommended patient-centered domains of interest. With its highly pragmatic approach and leadership of pharmacists, the VHA is an optimal setting in which to conduct the Pharm-UP study and positive results could fundamentally change how gout is managed in Veterans and beyond. Project Number: 1I01CX002995-01 | Fiscal Year: 2026 | NIH Institute/Center: Veterans Affairs (VA) | Principal Investigator: TED MIKULS (+1 co-PI) | Institution: OMAHA VA MEDICAL CENTER, OMAHA, NE | Activity Code: I01 | Study Section: Special Emphasis Panel[ZRD1 IMMA-G (01)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11182124