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临床试验/NCT06534554
NCT06534554招募中不适用

Improving Gout Care After an Emergency Department Visit for Acute Gout

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Follow-Up Visit Addressing Gout within 3 Months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years old
  • Able to communicate and understand English or Spanish
  • Confirmed acute gout flare by EMR review at ED visit

排除标准

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

研究组 & 干预措施

Patient Navigation

Experimental

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.

干预措施: Patient Navigation (Behavioral)

Control

No Intervention

Usual Care

结局指标

主要结局

Follow-Up Visit Addressing Gout within 3 Months

时间窗: 3 months

Proportion of patients that have a follow-up visit addressing gout in the 3-month period after the ED visit.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Saag, MD, MSc

Professor of Medicine

University of Alabama at Birmingham

研究点 (2)

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