Johnson Marcus R, Kenworthy-Heinige Tawni, Beck Danielle J, Asghar Aliya, Broussard Emily B, Bratcher Karen, Tommessilli Lynn M, Antonelli Margaret, Planeta Beata M
Cooperative Studies Program Epidemiology Center-Durham, Durham VA Health Care System, 508 Fulton Street (152), Durham, NC 27705, USA.
VA Portland Health Care System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.
Contemp Clin Trials Commun. 2018 Feb 3;9:172-177. doi: 10.1016/j.conctc.2018.01.011. eCollection 2018 Mar.
BACKGROUND/AIMS: The VA Cooperative Studies Program's (CSP) Network of Dedicated Enrollment Sites (NODES) is a consortium of nine VA medical centers (VAMCs) with teams (nodes) dedicated to enhance performance, compliance, and management of CSP multi-site clinical trials. The West Haven CSP Coordinating Center (WH-CSPCC), study coordinating center for CSP #577, looscopy Versus ecal mmunochemical Test (FIT) in educing ortality from Colorectal Cancer (CONFIRM) trial, and NODES piloted a "site mentoring" (hub-and-spoke) model. In this model, a node site would work one-on-one with a low enrolling CONFIRM site to identify and overcome barriers to recruitment. The aim was to determine the impact of a research site mentoring model on study recruitment and examine site-level characteristics that facilitate or impede it.
Sites in the mentorship pilot had an average improvement of 5 ± 4 participants randomized per month (min -2.6; max 11.6; SD 4.3). Four of ten sites (40%) demonstrated continuous improvement in the average number of randomized participants per month after the pilot intervention and at three-month follow-up (post-intervention), as compared to the five-month period preceding the intervention. An additional two sites (20%) demonstrated improvement in the average number of randomized participants per month after the pilot intervention, and sustained that level of improvement at three-month follow-up (post-intervention). Additionally, six of ten sites (60%) demonstrated an increased number of participants screened for eligibility immediately following the intervention and at three-month follow-up (post-intervention). Only one site showed a decreased monthly average of randomized participants shortly after the intervention and through the three-month follow-up period.
The site mentoring model was successful in improving recruitment at low enrolling CONFIRM sites. An additional feasibility assessment is needed to determine if this mentoring model will be effective with other CSP trials.
背景/目的：退伍军人事务部合作研究项目（CSP）的专用入组站点网络（NODES）是由9个退伍军人事务部医疗中心（VAMC）组成的联盟，各中心均有专门团队（站点）致力于提高CSP多中心临床试验的绩效、合规性和管理水平。西黑文CSP协调中心（WH-CSPCC）作为CSP #577（结肠镜检查与粪便免疫化学检测（FIT）降低结直肠癌死亡率（CONFIRM）试验）的研究协调中心，与NODES共同试点了一种“站点指导”（中心辐射）模式。在该模式中，一个节点站点将与入组率低的CONFIRM站点一对一合作，以识别并克服招募障碍。目的是确定研究站点指导模式对研究招募的影响，并考察促进或阻碍招募的站点层面特征。
参与指导试点的站点每月随机入组的参与者平均增加5±4名（最小值-2.6；最大值11.6；标准差4.3）。与干预前的五个月相比，十个站点中有四个（40%）在试点干预后及三个月随访（干预后）时，每月随机入组参与者的平均数持续增加。另外两个站点（20%）在试点干预后每月随机入组参与者的平均数有所增加，并在三个月随访（干预后）时维持该改善水平。此外，十个站点中有六个（60%）在干预后及三个月随访（干预后）时，符合资格筛选的参与者数量增加。只有一个站点在干预后不久至三个月随访期间，每月随机入组参与者的平均数有所下降。
站点指导模式成功提高了CONFIRM入组率低的站点的招募率。需要进行额外的可行性评估，以确定该指导模式对其他CSP试验是否有效。
