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临床试验/NCT05345054
NCT05345054已完成不适用

The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health

University of Alabama at Birmingham3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
3
主要终点
Barriers to surgical care for older African American patients in the Deep South.

研究概览

简要总结

Rationale: Older African Americans undergoing surgery are a vulnerable and growing population at high risk for poor surgical outcomes and disparities. Few programs have focused on this population due to a fragmented understanding of the needs of this population.

Objectives: While socioecological determinants of health (SEDOH) such as health literacy and socioeconomic status are known drivers of surgical disparities, an estimated 36-47% of surgical disparities remains unexplained. This gap results from limitations of current clinical datasets in capturing SEDOHs. This pilot study aims to fill this gap by (i) collecting granular SEDOH data, (ii) identifying barriers to surgical care for older African Americans, and (iii) establishing a multi-institutional clinical database through a socioecological context. These findings will help understand how SEDOHs drive surgical disparities and inform development of interventions to eliminate them in elderly African Americans.

Design and Methods: Guided by the socioecological model of health, the investigators will use mixed-methods to achieve the objectives. First, the investigators will assess the acceptability and feasibility of a 58-item SEDOH survey based on the NIH PhenX toolkit. After distributing this survey to 36 elderly (≥65 years) African American patients undergoing surgery at 3 rural, UAB-affiliated hospitals (Alex-City, Greenville, Demopolis) the investigators will conduct detailed theory guided assessments of acceptability and feasibility (SA1). Second, the investigators will conduct key informant interviews of individuals from all 5 socioecological levels at each rural hospital (n=10) to identify additional barriers and facilitators to surgical care. The investigators will purposively sample 100% of participants at the patient and caregiver level (n=12) to be elderly African Americans (SA2). Finally, the investigators will link measured SEDOH data with standardized clinical data at each hospital to establish a novel database (SA3). These findings will establish a process to measure SEDOHs across the Deep South and set the foundation for a unique database to study surgical disparities.

Significance: Development of effective multilevel interventions to eliminate surgical disparities in older African Americans is dependent on a clearer understanding of the contextual drivers of these disparities. This pilot study will accelerate understanding of these mechanism(s) through SEDOHs. It will establish a process to measure SEDOHs, identify additional barriers to surgical care not captured by NIH instruments, and build the database to study these relationships. Such findings will have the potential to impact vulnerable surgical populations in the Deep South and support the Deep South RCMAR mission to promote health and optimize health outcomes for older and rural African Americans.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Barriers to surgical care for older African American patients in the Deep South.

时间窗: 6 months

To identify barriers to surgical care for older African American patients in the Deep South the investigators will conduct qualitative interviews of participants at all socioecological levels at each site. These interviews will be transcribed and coded using NVivo software, and themes from this analysis will be compared with the domains assessed in the survey used in specific aim 1 in order to ensure that all relevant domains are captured and assessed.

Feasibility and Acceptability of a multidimensional survey in measuring socioecological determinants of health at rural hospitals in the Black Belt of Alabama (Demopolis, Alexander City, Greenville).

时间窗: 3 months

Using a theory guided framework and previously published measures of acceptability and feasibility, a post survey will be administered to all participants in specific aim 1. Feasibility and acceptability scores will be calculated, with positive acceptability and feasibility being indicated by scores of 4 or greater on a likert scale. The investigators will ensure that the survey is found to be acceptable and feasible to \>70% of the target population, and will have areas for qualitative feedback and comments to adapt the survey as needed.

A database linking socioecological determinants of health with nationally validated surgical outcomes.

时间窗: 12 months

To establish a database linking socioecological determinants of health with nationally validated surgical outcomes the investigators will pair data obtained from the previously developed survey with chart abstracted clinical outcomes data. All data will be stored in a secure RedCap database, and entered only by trained abstractors.

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

Daniel Chu

Associate Professor

University of Alabama at Birmingham

研究点 (3)

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