Improving Gout Care After an ED Visit
CARE-Gout
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2024
CompletedFirst Submitted
Initial submission to the registry
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
January 16, 2026
January 1, 2026
2.5 years
July 30, 2024
January 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Follow-Up Visit Addressing Gout within 3 Months
Proportion of patients that have a follow-up visit addressing gout in the 3-month period after the ED visit.
3 months
Study Arms (2)
Patient Navigation
EXPERIMENTALA 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.
Control
NO INTERVENTIONUsual Care
Interventions
A lay patient navigator working 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.
Eligibility Criteria
You may qualify if:
- ≥ 18 years old
- Able to communicate and understand English or Spanish
- Confirmed acute gout flare by EMR review at ED visit
You may not qualify if:
- Enrollment in an ongoing RCT (NCT04075903) testing a behavioral intervention employing "storytelling".
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 2, 2024
Study Start
June 18, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share