ClinicalTrials.gg
RecruitingNCT06534554CARE-GoutUpdated Jan 16, 2026

Improving Gout Care After an ED Visit

An interventional study of Patient Navigation in Gout, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Gout

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03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's planned enrollment of 200 is above the median of 83 across 286 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Enrollment in an ongoing RCT (NCT04075903) testing a behavioral intervention employing "storytelling".
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Patient Navigation

    A 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.

    Behavioral: Patient Navigation

  • No intervention
    Control

    Usual Care

Interventions

  • BehavioralPatient Navigation

    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.

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What researchers measure

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.

    Time frame: 3 months

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Study locations

1 of 1 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35205, United States
    Recruiting
    • Zac Armor · Contactzarmor@uabmc.edu · (205) 934-1779
    • Kenneth G. Saag, MD · Principal investigator
    • Lesley E. Jackson, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jan 2027, 30 months after the start.

Of 34 non-industry interventional studies with no phase under Gout, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 30 months is close to that.

Counting every sponsor, half of 35 studies reached it within 29 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2024
First posted
Aug 2, 2024
StartActual
Jun 18, 2024
Primary completionEst.
Jan 1, 2027
CompletionEst.
Jun 1, 2027
Last update
Jan 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06534554
Responsible party
Kenneth Saag, MD, MSc (Professor of Medicine, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 2, 2024
Start date
Jun 18, 2024
Primary completion
Jan 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jan 16, 2026

Study contacts

Lesley E. Jackson, MD
Contact
lejackson@uabmc.edu
(812) 322-0637
Zac Armor
Contact
zarmor@uabmc.edu
(205) 934-1779

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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