Utilization of an undergraduate emergency department research associate program for the screening and recruitment of research subjects with heart failure into a clinical study

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-01 DOI:10.1016/j.conctc.2024.101410

Dillon J. Dzikowicz , Brenda Hernandez-Romero , Nancy Wood , Beau W. Abar , David H. Adler , Linwei Wang , Wojciech Zareba

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引用次数: 0

Abstract

Background

Enrolling heart failure (HF) patients in clinical studies is challenging. Emergency department (ED) may use students as research associates programs, such as the University of Rochester Medical Center (URMC) ED Research Associate (EDRA) program, to screen and consent patients for clinical studies. This manuscript examines the effectiveness of the URMC EDRA program in consenting HF patients into a clinical study.

Methods

The URMC EDRA program recruited and consented HF patients presenting at URMC's ED. Research associates in the EDRA program identified potential patients based on age (>18 years) and chief complaints indicative of HF. After identifying potential patients, a thorough chart review was conducted, and any uncertainties were discussed with the patient and treating provider before patients were consented into the study. Descriptive statistics were used to assess the program's effectiveness.

Results

Over one fiscal year, the URMC EDRA program screened 1669 unique patients, of whom 118 (7.1 %) were consented. Consented patients tended to be younger (65 ± 12 years) than those who refused consent (70 ± 14 years) (p = 0.007). Of the 1551 patients not consented, 1021 (65.8 %) were deemed ineligible. Compared to a full time research associate, the URMC EDRA program was cheaper and more productive.

Conclusion

The URMC EDRA program was highly effective in screening and consenting HF patients, successfully consenting 118 patients (14 per month). This is a significant achievement, especially given the study's strict inclusion and exclusion criteria. Compared to other studies and a full time research associate, the URMC EDRA program demonstrated remarkable productivity.

查看原文本刊更多论文

利用本科急诊科研究助理计划筛选和招募心力衰竭研究对象进入临床研究。

背景：将心力衰竭（HF）患者纳入临床研究具有挑战性。急诊科（ED）可以使用学生作为研究助理项目，如罗切斯特大学医学中心（URMC） ED研究助理（EDRA）项目，筛选和同意患者进行临床研究。本文考察了URMC EDRA项目在同意HF患者进入临床研究中的有效性。方法：URMC EDRA项目招募并同意在URMC急诊科就诊的HF患者。EDRA项目的研究人员根据年龄（bb0 - 18岁）和表明HF的主诉确定潜在患者。在确定潜在患者后，进行彻底的图表审查，在患者同意参加研究之前，与患者和治疗提供者讨论任何不确定因素。描述性统计用于评估该计划的有效性。结果：在一个财政年度里，URMC EDRA项目筛选了1669名独特的患者，其中118名（7.1%）获得同意。同意患者年龄（65±12岁）大于拒绝同意患者年龄（70±14岁）（p = 0.007）。在1551名不同意的患者中，1021名（65.8%）被认为不符合条件。与全职研究助理相比，URMC EDRA项目成本更低，效率更高。结论：URMC EDRA项目在筛选和同意HF患者方面非常有效，成功同意118例患者（每月14例）。这是一项重大成就，特别是考虑到该研究严格的纳入和排除标准。与其他研究和全职研究人员相比，URMC EDRA项目显示出显着的生产力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.