Patient Navigation for Gout

(CARE-Gout Trial)

Overseen By Lesley E. Jackson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Enrollment in RCT NCT04075903

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for patients with gout after an emergency room visit. It employs a strategy called "patient navigation," where a guide assists patients in overcoming barriers to proper treatment and adherence to care plans. The trial also seeks to involve more minorities from the Southeastern U.S. in medical research. Individuals who have experienced a confirmed gout flare during an emergency room visit are well-suited for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance care strategies for gout patients.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Patient Navigation is safe for improving gout care?

Research has shown that patient navigation, where a trained guide assists patients in managing their healthcare, is generally safe and well-received. In areas like cancer care, studies have found that patients often appreciate the support they receive. As a supportive service, not a medication or procedure, patient navigation has shown no evidence of harm or major side effects.

While specific safety data for patient navigation in gout care is lacking, this method has successfully helped patients overcome treatment barriers in other areas. It focuses on improving communication and follow-up care, which are crucial for managing long-term conditions like gout. The goal is to simplify and enhance the healthcare process for patients, with minimal risk involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigation approach for gout because it offers a personalized support system that goes beyond medication. Unlike standard treatments that focus on managing symptoms with drugs like NSAIDs or urate-lowering therapies, Patient Navigation involves a dedicated guide who helps patients overcome barriers to attending follow-up care and adhering to treatment plans. This method addresses the practical and emotional challenges patients face, potentially leading to better long-term management of gout. By focusing on personalized support and patient empowerment, this approach could significantly improve adherence to treatment recommendations and overall patient outcomes.

What evidence suggests that Patient Navigation is effective for improving gout care?

This trial will compare the effectiveness of Patient Navigation services with usual care for managing gout. Research has shown that patient navigation can significantly improve healthcare outcomes. In particular, 24.3% of participants in studies who used patient navigation improved their blood sugar levels after a year, indicating its potential in managing long-term health issues. Patient navigation involves trained individuals who guide patients through the healthcare system, helping them adhere to treatment plans and attend follow-up visits. Other research has found that patient navigation can increase patient satisfaction and reduce costs for healthcare systems. Although specific results for gout are not well-documented yet, these findings suggest that patient navigation could enhance gout management, especially for those facing barriers to care. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have recently visited the emergency department (ED) for gout, a type of arthritis caused by excess uric acid. The study focuses on improving long-term care and acute treatment in the Southeastern U.S., with an emphasis on including African Americans.

Inclusion Criteria

Confirmed acute gout flare by EMR review at ED visit

Exclusion Criteria

Enrollment in an ongoing RCT (NCT04075903) testing a behavioral intervention employing 'storytelling'

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Patient navigators contact patients within 72 hours post-ED visit to assess barriers and support needs for gout care

1 week

1 visit (phone call)

Follow-up

Participants are monitored for follow-up visits addressing gout care within 3 months post-ED visit

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview

The intervention being tested is 'Patient Navigation,' which may involve personalized guidance and support to help patients manage their gout after an ED visit. The goal is to improve overall care and encourage minority participation in research.

How Is the Trial Designed?

Group I: Patient Navigation Experimental Treatment 1 Intervention

A lay patient navigator will contact patients seen in the UAB ED via phone within \~72 hours following the ED visit. During this initial phone conversation, the navigators will: 1) conduct a baseline assessment to identify barriers to attending an outpatient visit for gout care and to adhering to gout treatment recommendations and 2) determine the level of support and assistance needed by the patient.

Group II: Control Active Control 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The pilot study involved 75 elderly patients, primarily female, who received patient navigation services from a social worker, helping them effectively navigate the complex US healthcare system.

Patients reported finding the navigation services very helpful, and physicians recognized the PN as a valuable addition to the practice, indicating that integrating patient navigation into primary care can significantly benefit those with complex healthcare needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the patient navigator approach to meet the needs of primary care. Ferrante, JM., Cohen, DJ., Crosson, JC.[2022]

The breast cancer navigation (BCN) program significantly improved physician workflows, with many physicians stating it made their day easier and enhanced care coordination and patient experience.

Patients also reported high satisfaction with the support they received during diagnosis communication, indicating that the BCN program effectively met their needs during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. Dillon, EC., Kim, P., Li, M., et al.[2021]

Patient navigation did not significantly improve the transition rate from hospital to the High-Risk Osteoporosis Clinic (HiROC) for patients with fragility fractures, with rates of 53% for navigated patients compared to 48% for those without navigation.

However, patient navigation did lead to a higher completion rate of Dual-energy X-ray Absorptiometry (DXA) scans (90% vs. 67%), suggesting that while it may not enhance overall transition rates, it can improve specific follow-up care aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporation of a patient navigator into a secondary fracture prevention program identifies barriers to patient care. Jia, KQ., Southerland, L., Phieffer, L., et al.[2022]

Patient navigation by nurses significantly improved glycemic control, with 24.3% of participants showing better blood sugar levels after a year of follow-up, indicating its efficacy in managing type 1 diabetes.

The intervention also enhanced diabetes knowledge and self-care adherence in 53.9% of participants, suggesting that structured support can lead to better health outcomes for individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of patient navigation on glycemic control, adherence to self-care and knowledge about diabetes: an intervention study. Foppa, L., Nemetz, B., de Matos, R., et al.[2023]

A cross-sectional study involving 162 clinical commissioning groups (CCGs) in England found that over 90% have implemented some form of care navigation to assist patients with non-medical needs affecting their health.

Despite the widespread implementation, the study revealed significant variability in how care navigation is defined and executed, which may lead to confusion among patients and challenges in evaluating the effectiveness of these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current understanding and implementation of 'care navigation' across England: a cross-sectional study of NHS clinical commissioning groups. Tierney, S., Wong, G., Mahtani, KR.[2020]

A study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

The lay-led health navigator model in a rural New Zealand setting effectively supported vulnerable individuals facing multiple health barriers, demonstrating its importance in improving access to care in underserved areas.

Survey results indicated high satisfaction among users of the navigator service, highlighting its positive impact on connecting clients with health and social care services despite challenges in implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of a health navigator model of care within a primary care setting: a case study. Doolan-Noble, F., Smith, D., Gauld, R., et al.[2013]

Patient navigators can improve certain health outcomes for patients with chronic kidney disease (CKD) and kidney failure, such as enhancing transplant workup and listing, increasing peritoneal dialysis utilization, and boosting patient knowledge, based on a review of 17 studies.

However, many studies had a high risk of bias and did not demonstrate benefits across all outcomes, highlighting the need for more rigorous randomized controlled trials to assess the overall efficacy and cost-effectiveness of navigator programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigators for CKD and Kidney Failure: A Systematic Review. Taha, A., Iman, Y., Hingwala, J., et al.[2022]

The implementation of a novel patient navigation (P.N.) program, called EDAP, did not significantly change the overall timeliness of care for esophageal cancer patients, but it did improve care for those undergoing curative multimodality therapy.

In the subgroup of patients receiving curative treatment, the time from biopsy to first treatment decreased significantly from 60 to 51 days, indicating that the P.N. program effectively streamlined the care process for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of a patient navigation program on timeliness of care in patients with esophageal cancer. Arora, N., Lo, M., Hanna, NM., et al.[2023]

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27771161/

A meta-analysis of randomized controlled trials

Abstract. Objective: To determine the effects of patient navigation (PN) on healthcare utilization outcomes using meta-analysis and the quality of evidence.

2.

withpower.com

withpower.com/trial/phase-gout-5-2024-62b68

Patient Navigation for Gout (CARE-Gout Trial)

Patient navigation by nurses significantly improved glycemic control, with 24.3% of participants showing better blood sugar levels after a year of follow-up, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06534554?cond=gout&viewType=Table&rank=3

NCT06534554 | Improving Gout Care After an ED Visit

Patient navigators are trained, lay individuals of similar cultural background, and region, who provide personal guidance to patients and engage "hard-to-reach" ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7217374/

Effects of Patient Navigation on Patient Satisfaction Outcomes

The objectives of this study are to test the effects of PN on patient satisfaction with cancer care, assess patients' satisfaction with navigators, and examine ...

5.

cancerletter.com

cancerletter.com/the-cancer-letter/20241122_2/

Patient navigation benefits health systems, improves care

Data from early adopters show that navigation services are leading to better outcomes, significant cost savings for healthcare systems, and mitigation of ...

6.

link.springer.com

link.springer.com/article/10.1007/s40744-025-00794-2

The Impact of Uncontrolled Gout on Healthcare Utilization ...

This study sought to identify patients with gout and to describe the differences in epidemiology, pharmacotherapy, healthcare utilization, and ...

7.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.00244/full

Compliance of Primary Care Providers With Gout ...

The primary aims of this study were to assess primary care providers' knowledge regarding gout and to determine if their treatment decisions are influenced by ...

8.

cdc.gov

cdc.gov/cancer/php/interventions/patient-navigation.html

Patient Navigation | Cancer

Identify what data will be needed. Use the Patient Navigation Barriers and Outcomes Tool developed by George Washington University as a guide.