Increasing access to clinical research using an innovative mobile recruitment approach: The (MoRe) concept

Increasing access to clinical research using an innovative mobile recruitment approach: The (MoRe) concept
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DOI:
10.1016/j.conctc.2020.100623
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发表时间:
2020-09-01
影响因子:
1.5
通讯作者:
Huang, Grant D.
Huang, Grant D.
中科院分区:
其他
文献类型:
--
作者:
Beck, Danielle;Asghar, Aliya;Huang, Grant D.

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背景:获得医疗保健提供方案和系统是与退伍军人和普通民众的整体健康和福祉相关的主要因素。参与临床研究是通往旨在解决当前全球健康问题的新疗法的大门。达到或超过临床研究的招募目标是及时和成功完成一项研究的关键决定因素之一。研究参与者经历的旅行和时间负担通常被认为是他们进入临床研究的障碍。退伍军人事务部(退伍军人事务部)合作研究计划(CSP)建立了一个由9个退伍军人医疗中心(VAMCs)组成的联盟,称为专用招生地点网络(NODES)。Nodes计划提供研究现场级别的专业知识和创新方法,以应对临床研究执行方面的挑战。为了与我们的使命保持一致,我们的计划开发了一种方法,通过实施“流动招募(更多)”单元来增加研究参与者获得临床研究的机会。这篇手稿描述了使用这一策略来解决临床研究参与的三个常见障碍的效用和挑战:1)研究参与者的旅行负担,2)参与者获得研究机会,以及3)参与者参与率低。方法:在退伍军人医疗保健系统中,引入流动招募(MORE)单位作为招募战略的计划被试行,以进行大量的观察性队列研究和大型生物库,即“百万退伍军人计划(MVP)”。更多的是CSP研究的招聘战略,整合了移动技术和非典型研究招聘地点。招聘地点包括初级或主要退伍军人医院及其分配的退伍军人社区门诊诊所(CBOC)。每个节点站点(n=9)收到了MORE单元的部件,包括笔记本电脑、打印机、带存储空间的便携式手推车、用于样品存储和运输的冷藏箱/冰袋。每个站点对这些组件的使用根据其各自的需求而有所不同。活动集中在退伍军人管理局主要设施和CBOC设施进行招募。结果:在9个节点站点中,有7个站点在干预前、干预期间和干预后三个时间点上比较了MVP研究招生结果的有效性。在干预期间对MORE的利用表明,与前六个月(干预前)相比,注册人数增加了36.9%。与干预期相比,干预后6个月的登记人数增加了2%。干预前和干预后(为期18个月)相比,登记人数增加了38.9%。结论:7个地点中有5个在干预期间和干预后登记人数增加。这两个注册人数没有增加的网站经历了各种可以减轻损失的因素。
Background: Access to healthcare delivery programs and systems is a primary correlate to the overall health and well-being of Veterans and the general population. Participation in clinical research is a gateway to novel therapies that are intended to address current global health issues. Meeting or exceeding recruitment goals in clinical research is one of the key determinants of the timely and successful completion of a study. The travel and time burdens experienced by study participants are often considered barriers to their enrollment into clinical research. The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) established a consortium of nine VA medical centers (VAMCs) called the Network of Dedicated Enrollment Sites (NODES). The NODES program provides study site-level expertise and innovative approaches that address challenges to clinical research execution. In alignment with our mission, our program developed an approach to increase study participant access to clinical research through implementing "Mobile Recruitment (MoRe)" units. This manuscript describes the utility and challenges associated with employing this strategy to address three common barriers to clinical research participation: 1) research participant travel burden, 2) participant access to study opportunities, and 3) low participant enrollment.Methods: A plan to introduce the Mobile Recruitment (MoRe) unit as a recruitment strategy was piloted for a high-volume, observational cohort study and mega biobank in the VA health care system, the "Million Veteran Program (MVP)". MoRe is a recruitment strategy for CSP research integrating mobile technology and atypical research recruitment locations. Recruitment locations include primary or main VA hospitals and their assigned VA Community-Based Outpatient Clinics (CBOCs). Each Node site (n = 9) received components of the MoRe unit including a laptop, printer, portable cart with storage space, cooler/ice packs for specimen storage and transport. Each site's usage of these components varied based on its respective needs. Activities focused on both VA main facilities and CBOC facilities for recruitment.Results: Seven of the nine Node sites compared the effectiveness of the MoRe unit on MVP study enrollment outcomes over three-time points: pre-intervention period, intervention period, and post-intervention period. The utilization of MoRe in the intervention period demonstrated a 36.9% increase in enrollment compared to the previous six months (pre-intervention period). There was a 2% enrollment increase at the six-month postintervention period as compared to the intervention period. When comparing the pre-intervention period to the post-intervention period (duration of eighteen months), enrollment increased by 38.9%.Conclusion: Five of the seven sites experienced an increase in enrollment during the intervention and postintervention periods. The two sites without an increase in enrollment experienced various extenuating factors.