Gout in the ED and Improving Research Participation

NCT ID: NCT04075903

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2026-02-01

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.

Conditions

Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Storytelling A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing "storytelling" to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, or ii) usual gout care (control state).

Group Type: EXPERIMENTAL

Storytelling

Intervention Type: BEHAVIORAL

A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing "storytelling" to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, or ii) usual gout care (control state).

Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Storytelling

A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing "storytelling" to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, or ii) usual gout care (control state).

Intervention Type: BEHAVIORAL

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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Saag, MD, MSc

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

300003869

Identifier Type: -

Identifier Source: org_study_id

P50AR060772

Identifier Type: NIH

Identifier Source: secondary_id

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