Pharmacist-Led Therapy for Gout

(Pham-UP Trial)

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

310 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Pharmacist-Led for gout?

Research shows that pharmacist-led interventions can improve gout management by helping patients adhere to their medication plans and achieve better control of uric acid levels, which are crucial for managing gout effectively. ^{1 2 3 4 5}

Is pharmacist-led therapy for gout safe for humans?

The research does not provide specific safety data on pharmacist-led therapy for gout, but it highlights the role of pharmacists in managing medication safety, such as screening for risks and providing safety information, particularly with non-steroidal anti-inflammatory drugs (NSAIDs). ^{1 5 6 7 8}

How is pharmacist-led treatment for gout different from other treatments?

Pharmacist-led treatment for gout is unique because it involves pharmacists actively managing the condition through structured protocols, focusing on improving medication adherence and patient education. This approach is more effective than usual care by primary providers, as it emphasizes personalized support and decision-making involvement for patients. ^{2 3 9 10 11}

Research Team

Ted R. Mikuls

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacist knowledge of gout management: impact of an educational intervention. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Adherence and Outcomes with Urate-Lowering Therapy: A Site-Randomized Trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a pharmacist-based gout care management programme in a large integrated health plan: results from a pilot study. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Pharmacist-managed titration of urate-lowering therapy to streamline gout management. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Exploring current and potential roles of Australian community pharmacists in gout management: a qualitative study. [2019]

6. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Evaluation of the community pharmacists' performance in the screening of non-steroidal anti-inflmmatory drugs risks in Saudi Arabia. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of pharmacist-led patient counseling in randomized controlled trials: a systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of community pharmacists' roles in screening and communication of risks about non-steroidal anti-inflammatory drugs in Thailand. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Are Doctors the Best People to Manage Gout? Is There a Role for Nurses and Pharmacists? [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Pilot study of a multidisciplinary gout patient education and monitoring program. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Expanding the role of Australian community dietitians in gout management. [2022]