Blewer Audrey L, Li Jiaqi, Ikeda Daniel J, Leary Marion, Buckler David G, Riegel Barbara, Desai Sunita, Groeneveld Peter W, Putt Mary E, Abella Benjamin S
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.
Clin Trials. 2016 Aug;13(4):425-33. doi: 10.1177/1740774516643265. Epub 2016 Apr 19.
BACKGROUND/AIMS: Recruitment of subjects is critical to the success of any clinical trial, but achieving this goal can be a challenging endeavor. Volunteer nurse and student enrollers are potentially an important source of recruiters for hospital-based trials; however, little is known of either the efficacy or cost of these types of enrollers. We assessed volunteer clinical nurses and health science students in their rates of enrolling family members in a hospital-based, pragmatic clinical trial of cardiopulmonary resuscitation education, and their ability to achieve target recruitment goals. We hypothesized that students would have a higher enrollment rate and are more cost-effective compared to nurses.
Volunteer nurses and student enrollers were recruited from eight institutions. Participating nurses were primarily bedside nurses or nurse educators while students were pre-medical, pre-nursing, and pre-health students at local universities. We recorded the frequency of enrollees recruited into the clinical trial by each enroller. Enrollers' impressions of recruitment were assessed using mixed-methods surveys. Cost was estimated based on enrollment data. Overall enrollment data were analyzed using descriptive statistics and generalized estimating equations.
From February 2012 to November 2014, 260 hospital personnel (167 nurses and 93 students) enrolled 1493 cardiac patients' family members, achieving target recruitment goals. Of those recruited, 822 (55%) were by nurses, while 671 (45%) were by students. Overall, students enrolled 5.44 (95% confidence interval (CI): 2.88, 10.27) more subjects per month than nurses (p < 0.01). After consenting to participate in recruitment, students had a 2.85 (95% CI: 1.09, 7.43) increased chance of enrolling at least one family member (p = 0.03). Among those who enrolled at least one subject, nurses enrolled a mean of 0.51(95% CI: 0.42, 0.59) subjects monthly, while students enrolled 1.63 (95% CI: 1.37, 1.90) per month (p < 0.01). Of 198 surveyed hospital personnel (127 nurses, 71 students), 168/198 (85%) felt confident conducting enrollment. The variable cost per enrollee recruited was $25.38 per subject for nurses and $23.30 per subject for students.
Overall, volunteer students enrolled more subjects per month at a lower cost than nurses. This work suggests that recruitment goals for a pragmatic clinical trial can be successfully obtained using both nurses and students.
背景/目的:受试者招募对于任何临床试验的成功都至关重要,但实现这一目标可能是一项具有挑战性的工作。志愿护士和学生招募者可能是医院临床试验招募人员的重要来源;然而,对于这类招募者的效果或成本知之甚少。我们评估了志愿临床护士和健康科学专业学生在一项基于医院的心肺复苏教育实用临床试验中招募家庭成员的比例,以及他们实现目标招募目标的能力。我们假设学生的招募率会更高,并且与护士相比更具成本效益。
从8个机构招募志愿护士和学生招募者。参与的护士主要是床边护士或护士教育工作者,而学生是当地大学的医学预科、护理预科和健康预科学生。我们记录了每位招募者招募进入临床试验的受试者频率。使用混合方法调查评估招募者对招募工作的印象。根据招募数据估算成本。使用描述性统计和广义估计方程分析总体招募数据。
2012年2月至2014年11月,260名医院工作人员(167名护士和93名学生)招募了1493名心脏病患者的家庭成员,实现了目标招募目标。在招募的人员中,822名(55%)由护士招募,而671名(45%)由学生招募。总体而言,学生每月招募的受试者比护士多5.44名(95%置信区间(CI):2.88,10.27)(p<0.01)。在同意参与招募后,学生招募至少一名家庭成员的几率增加了2.85倍(95%CI:1.09,7.43)(p=0.03)。在那些至少招募了一名受试者的人中,护士每月平均招募0.51名(95%CI:0.42,0.59)受试者,而学生每月招募1.63名(95%CI:1.37,1.90)(p<0.01)。在接受调查的198名医院工作人员(127名护士,71名学生)中,168/198(85%)的人对进行招募工作有信心。护士招募每名受试者的可变成本为25.38美元/名,学生为23.30美元/名。
总体而言,志愿学生每月招募的受试者比护士多,且成本更低。这项工作表明,使用护士和学生都可以成功实现实用临床试验的招募目标。