Pharmacist-Led Therapy for Gout

(Pham-UP Trial)

Not yet recruiting at 4 trial locations

Overseen By Bridget Kramer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Uric acid reducers

Disqualifiers: Rheumatology encounter, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to manage gout by lowering uric acid levels, emphasizing a pharmacist-led approach. One group of participants will have regular telehealth visits with pharmacists, while the other group will receive standard care from their usual doctor. It is well-suited for U.S. Veterans diagnosed with gout, who have high uric acid levels, and have experienced at least one gout flare in the past six months. As an unphased trial, this study provides a unique opportunity to explore innovative care methods and contribute to improving gout management.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have a new or existing prescription for uric acid-lowering therapy (ULT) like allopurinol or febuxostat.

What prior data suggests that this pharmacist-led therapy is safe for managing gout?

Research has shown that pharmacist-led care can safely and effectively manage gout. In previous studies, programs led by pharmacists helped patients take their medications on time and reach their uric acid targets, which is crucial for treating gout. No serious safety issues were reported, indicating that this approach is well-tolerated.

In these programs, pharmacists often work closely with patients, assisting them in following their treatment plans. This collaboration not only improves health outcomes but also enhances patients' understanding of their treatments. Overall, these findings suggest that pharmacist-led care is a safe option for managing gout. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacist-led therapy for gout because it offers a personalized approach to managing the condition. Unlike the usual care where treatment is managed primarily by general healthcare providers, this method involves regular telehealth visits with pharmacists who specialize in gout management. This allows for more precise adjustments in medication dosing based on real-time serum urate levels, potentially leading to better control of gout symptoms. This approach aims to optimize treatment efficacy and patient outcomes by leveraging specialized pharmacist expertise and telehealth technology.

What evidence suggests that pharmacist-led therapy is effective for managing gout?

This trial will compare pharmacist-led therapy with usual care for managing gout. Research has shown that pharmacist involvement in gout care can lead to better health outcomes. One study found that patients were more successful in reaching their uric acid targets with a pharmacist's help. Another study demonstrated that these programs could safely lower and maintain uric acid levels in many people with recurring gout. Additionally, a structured program led by pharmacists helped patients adhere to their medication regimen. These findings suggest that pharmacist involvement in gout treatment can improve condition management. ^{1 2 5 6 7}

Who Is on the Research Team?

Ted R. Mikuls

Principal Investigator

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Are You a Good Fit for This Trial?

This trial is for individuals with gout, a type of arthritis caused by excess uric acid. Participants should be receiving care at one of the five participating VA medical centers and willing to follow treatment for up to two years.

Inclusion Criteria

Patients must satisfy ACR/EULAR gout classification criteria

I have experienced one or more flares in the last 6 months.

I started a new gout medication prescribed by my primary care doctor.

Exclusion Criteria

I cannot tolerate or take gout medications like allopurinol or febuxostat.

I saw a rheumatologist in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pharmacist-led telehealth-delivered intervention or usual care for gout management

24 months

Regular telehealth visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist-Led

Trial Overview The study is testing a pharmacist-led approach to managing medications that lower uric acid levels in patients with gout. It compares this method against standard practices over a period of 4-5 years across multiple sites.

How Is the Trial Designed?

Group I: Pharmacist-Led Experimental Treatment 1 Intervention

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

Group II: Usual care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1551741125003754

Effectiveness of pharmacist-led interventions in improving ... This systematic review aims to evaluate the impact of pharmacist-led interventions in improving gout outcomes in people living with gout.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6399023/

A Pharmacist-Led Intervention to Improve Gout Medication ... A pharmacist-led intervention incorporating automated telephone technology improved adherence and serum urate goal achievement in gout patients ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/4/1/e003627

Effectiveness of a pharmacist-based gout care ... A structured pharmacist-staffed programme can effectively and safely lower and maintain uric acid levels in a high percentage of patients with recurrent gout ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT06887452

Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients ... Phase 2: Studies that gather preliminary data on effectiveness ... The project will quantify the effects of the intervention on patient-reported outcomes ...

5. thepermanentejournal.org thepermanentejournal.org/doi/10.7812/TPP/15-234

A Pharmacist-Staffed, Virtual Gout Management Clinic for ... Primary outcome measure was achieving sUA levels at or below 6 mg/dL at the 26-week visit. Secondary outcome was mean change in sUA levels ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06887452

Pharmacist-Led Treat-to-Target Urate Lowering Therapy in ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/20101058231152048

Impact of pharmacist-led collaborative gout clinic on timely ... Our results demonstrate the use of a pharmacist-led collaborative gout clinic may help to achieve better clinical outcomes in gout management. Introduction.