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Gout in the ED and Improving Research Participation

Improving Care for Gout in the Southeast Enhancing Gout Minority Patients Care and Participation in Gout Clinical Research

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04075903
Enrollment
200
Registered
2019-09-03
Start date
2021-06-01
Completion date
2026-02-01
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

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.

Interventions

BEHAVIORALStorytelling

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).

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
MetroHealth Medical Center
CollaboratorOTHER
University of Iowa
CollaboratorOTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Outpatient Primary Care or Specialist Visits for Gout Treatment3 monthsProportion of participants who attend a primary care or specialist visits for gout treatment

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Storytelling and Navigation 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, along with post-emergency department visit patient navigation to promote outpatient follow-up.
135
Control
Usual Care
65
Total200

Baseline characteristics

CharacteristicInterventionControlTotal
Age, Continuous57.6 years
STANDARD_DEVIATION 13.6
58.9 years
STANDARD_DEVIATION 12.4
58 years
STANDARD_DEVIATION 13.1
Alcohol Use
2-4 times per month
53 Participants22 Participants75 Participants
Alcohol Use
2 or more times per week
24 Participants10 Participants34 Participants
Alcohol Use
Never
54 Participants33 Participants87 Participants
Education Level
4-year Degree or More Completed
23 Participants12 Participants35 Participants
Education Level
High School Graduate or Less
65 Participants30 Participants95 Participants
Education Level
Vocational Training or Some College
44 Participants23 Participants67 Participants
Employment Status
Full-Time Work
61 Participants19 Participants80 Participants
Employment Status
Other or Choose not to Answer
8 Participants8 Participants16 Participants
Employment Status
Part-Time Work or Not Seeking Work
37 Participants22 Participants59 Participants
Employment Status
Unemployed
25 Participants16 Participants41 Participants
Race/Ethnicity, Customized
Asian, Hispanic or Latino, Unknown/Other
8 Participants4 Participants12 Participants
Race/Ethnicity, Customized
Black or African American
92 Participants45 Participants137 Participants
Race/Ethnicity, Customized
White
35 Participants16 Participants51 Participants
Sex: Female, Male
Female
34 Participants15 Participants49 Participants
Sex: Female, Male
Male
101 Participants50 Participants151 Participants
Smoking Status
Currently Smoking Everyday
17 Participants9 Participants26 Participants
Smoking Status
Currently Smoking Some Days
18 Participants4 Participants22 Participants
Smoking Status
Not Smoking at All
97 Participants50 Participants147 Participants
Yearly Income
$30,000 to less than $60,000
13 Participants13 Participants26 Participants
Yearly Income
$60,000 to less than $100,000
14 Participants8 Participants22 Participants
Yearly Income
Greater than $100,000
11 Participants4 Participants15 Participants
Yearly Income
Less than $30,000
42 Participants20 Participants62 Participants
Yearly Income
Prefer not to answer
44 Participants18 Participants62 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1350 / 65
other
Total, other adverse events
0 / 1350 / 65
serious
Total, serious adverse events
0 / 1350 / 65

Outcome results

Primary

Outpatient Primary Care or Specialist Visits for Gout Treatment

Proportion of participants who attend a primary care or specialist visits for gout treatment

Time frame: 3 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionOutpatient Primary Care or Specialist Visits for Gout TreatmentPresence of Gout Follow-Up64 Participants
ControlOutpatient Primary Care or Specialist Visits for Gout TreatmentPresence of Gout Follow-Up35 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026