Clinical trial NCT06534554: Improving Gout Care After an ED Visit
Official title: Improving Gout Care After an Emergency Department Visit for Acute Gout
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gout
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 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.

Detailed description: The prevalence of gout has been steadily increasing and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeast U.S. - particularly in African Americans. Many patients with acute gout receive care at the emergency department (ED), particularly underserved urban populations in the Deep South. Appropriate outpatient follow-up for an acute flare after an ED visit is variable. Indeed, in a preliminary analysis of a retrospective cohort study of patients with acute gout treated at our urban medical center ED, only 46% of patients followed up with an outpatient clinician in our healthcare system within 6 months of their ED visit. Even fewer (36%) had an outpatient visit specifically addressing gout care within 6 months post-ED visit. This population of patients that seek acute gout care in the ED represent an important group that may benefit from interventions focused on improving gout quality of care, such as promoting outpatient follow-up.

While having a mechanism to identity acute gout patients in the ED is fundamental for enhancing care for patients with acute gout, recruiting people with acute gout who receive care in the ED outside regular business hours is challenging. One potential solution involves approaching patients after their ED visits remotely using patient navigators. The 36-72 hour period after their ED visit represents a critical time during which patients may be more receptive to efforts focused on improving healthy behaviors including scheduling outpatient follow-up (i.e., a "teachable moment). Patient navigators are trained, lay individuals of similar cultural background, and region, who provide personal guidance to patients and engage "hard-to-reach" groups, reduce access barriers, and encourage healthy behaviors such as engaging in outpatient chronic disease management.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Able to communicate and understand 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".

Primary outcomes:
measure: Follow-Up Visit Addressing Gout within 3 Months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: