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

Trial Summary

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 data supports the effectiveness of the treatment Patient Navigation for Gout?

Research shows that patient navigation can help improve adherence to treatment and knowledge about managing conditions like diabetes, and it can also enhance the timeliness of care in cancer patients. This suggests that similar benefits might be seen in managing gout, as patient navigation helps people better understand and follow their treatment plans. ^{1 2 3 4 5}

How is the patient navigation treatment for gout different from other treatments?

Patient navigation for gout is unique because it focuses on helping patients effectively use the healthcare system and coordinate their care, rather than directly treating the disease itself. This approach is adapted from models used in cancer care and aims to address non-medical barriers to health, which can be particularly beneficial for underserved populations. ^{6 7 8 9 10}

What is the purpose of this trial?

The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

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

Influence of a patient navigation program on timeliness of care in patients with esophageal cancer. [2023]

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

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. [2021]

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

The impact of patient navigation on glycemic control, adherence to self-care and knowledge about diabetes: an intervention study. [2023]

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Incorporation of a patient navigator into a secondary fracture prevention program identifies barriers to patient care. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Current understanding and implementation of 'care navigation' across England: a cross-sectional study of NHS clinical commissioning groups. [2020]

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

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Evolution of a health navigator model of care within a primary care setting: a case study. [2013]

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

Translating the patient navigator approach to meet the needs of primary care. [2022]

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

Patient Navigators for CKD and Kidney Failure: A Systematic Review. [2022]