Clinical trial NCT04075903: Gout in the ED and Improving Research Participation
Official title: Improving Care for Gout in the Southeast Enhancing Gout Minority Patients Care and Participation in Gout Clinical Research
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gout
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: MetroHealth Medical Center
name: University of Iowa
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-09-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 emergency department led 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.

Detailed description: Gout is a chronic disease that affects over 9 million Americans. It is characterized by intermittent flares associated with severe pain. The prevalence of gout has been steadily increasing over several decades and it correlates with the rising burden of obesity, chronic cardiac and renal disease, all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. In addition, many gout patients are not adherent with their follow-up visits due to a lack of awareness of the consequences of untreated gout and/or poor access to health care. As a result, US emergency departments (EDs) are delivering an increasing amount of gout care for underserved populations.

To address this significant public health problems teams at the University of Alabama at Birmingham (UAB), University of Iowa, Massachusetts General Hospital (MGH), and MetroHealth Medical Center are collaborating on a novel emergency department-led intervention aimed at improving the gout care patients receive, during periods of acute flare and long-term. Investigators hypothesize that the use of educational material including cultural appropriate stories about what it is like to live with gout and the use of navigators who will help patients better coordinate their care, will be associated with improved rates of patients that have a follow-up visit addressing gout after the ED visit. A secondary goal is to enhance participation of underrepresented minorities in biomedical research in the Deep South as part of an NIH funded gout center at UAB.

Investigators will recruit and enroll adults (at least 18 years of age) that have confirmed gout. Participants will include men and women of all races/ethnicities. Recruitment will occur in the EDs at UAB, University of Iowa, MGH, and MetroHealth. Qualifying patients will be assigned by chance to get either 1) our enhanced educational materials coupled (at UAB) with a lay person who can help them coordinate their care or 2) to receive the current usual standard of care for their gout. After a gout diagnosis is confirmed by a research assistant, informed consent will be obtained. Following enrollment, participants will complete questionnaires at 3 and 6 months. Beyond follow-up visits, Investigators will also measure differences in the groups between the use of medication for gout treatment, other healthcare visits, changes in weight, satisfaction, and overall health during study follow-up. Leveraging the resources of UAB, including the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funded Center of Research Translation (CORT) in gout and hyperuricemia and ongoing collaborations between these medical institutions, Investigators have assembled a multidisciplinary scientific team, uniquely prepared to execute the proposed study to help medically underserved gout patients and enhance research diversity in the Southeast.

Eligibility criteria: Inclusion Criteria:

* Gout diagnosis meeting 2015 American College of Rheumatology and European League Against Rheumatism classification criteria,99,140
* Adult \> 18 years of age
* Able to communicate and understand English language (a future objective, with additional resources, will include Spanish translation of all study materials).

Key exclusion criteria:

* Joint complaint related to significant trauma or recent surgery (\<1 month)
* Life expectancy of \< 6 months
* Current critical illness leading to admission to high acuity medical care unit (ICU, stepdown unit) or requiring surgical intervention (general anesthesia); confirmed septic arthritis or joint infectious arthritis

Primary outcomes:
measure: Outpatient primary care or specialist visits for gout treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
References: