Patient Navigation for Gout
(CARE-Gout Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Enrollment in RCT NCT04075903
No Placebo Group
Trial Summary
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.
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.
12345How 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.
678910Eligibility 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
I am 18 years old or older.
I can communicate and understand either English or Spanish.
Confirmed acute gout flare by EMR review at ED visit
Exclusion Criteria
Enrollment in an ongoing RCT (NCT04075903) testing a behavioral intervention employing 'storytelling'
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient NavigationExperimental Treatment1 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: ControlActive Control1 Intervention
Usual Care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Influence of a patient navigation program on timeliness of care in patients with esophageal cancer. [2023]Patient navigation (P.N.) is designed to eliminate barriers to care. The objective of this study was to evaluate the impact of a novel P.N. program on timeliness of care in patients with esophageal cancer.
Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. [2021]Patient navigators can improve patient experiences of care and outcomes, but little is known about how navigation programs may affect physician workflows and experience.
The impact of patient navigation on glycemic control, adherence to self-care and knowledge about diabetes: an intervention study. [2023]Patient navigation helps with better adherence to treatment, as well as better knowledge about diabetes and greater interest in performing, monitoring, and seeking health care. Therefore, this study aims to evaluate the effect of patient navigation on glycemic control, disease knowledge, adherence to self-care in people with type 1 diabetes mellitus.
Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]Patient navigation (PN) programs can improve cancer screening in underserved populations. PN may advance quality and equity of care by supporting individuals at increased risk of not receiving recommended care.
Incorporation of a patient navigator into a secondary fracture prevention program identifies barriers to patient care. [2022]Patient navigation improves outcomes in various clinical contexts, but has not been evaluated in secondary fracture prevention.
Current understanding and implementation of 'care navigation' across England: a cross-sectional study of NHS clinical commissioning groups. [2020]Care navigation is an avenue to link patients to activities or organisations that can help address non-medical needs affecting health and wellbeing. An understanding of how care navigation is being implemented across primary care is lacking.
Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]Patient navigation is a barrier-focused program of care coordination designed to achieve timely and high-quality cancer-related care for medically underserved racial-ethnic minorities and the poor. However, to the authors' knowledge, few studies to date have examined the relationship between satisfaction with navigators and cancer-related care.
Evolution of a health navigator model of care within a primary care setting: a case study. [2013]Patient navigation originated as an approach for reducing disparities in cancer care and consequent health outcomes. Over time navigator models have evolved and been used to address various health issues in differing contexts. This case study outlines the evolution, purpose and effects of a lay-led health navigator model in a deprived, sparsely populated, New Zealand rural setting, where primary care services are frequently understaffed and routinely overstretched.
Translating the patient navigator approach to meet the needs of primary care. [2022]Helping patients navigate the complex and fragmented US health care system and coordinating their care are central to the patient-centered medical home. We evaluated the pilot use of a patient navigator (PN), someone who helps patients use the health care system effectively and efficiently, in primary care practices.
Patient Navigators for CKD and Kidney Failure: A Systematic Review. [2022]To what degree and how patient navigators improve clinical outcomes for patients with chronic kidney disease (CKD) and kidney failure is uncertain. We performed a systematic review to summarize patient navigator program design, evidence, and implementation in kidney disease.