Pediatrics, University of California San Francisco, San Francisco, California, USA
School of Medicine, Mayo Clinic School of Medicine, Rochester, Minnesota, USA.
BMJ Health Care Inform. 2021 Jan;28(1). doi: 10.1136/bmjhci-2019-100076.
Interactive patient care systems (IPCS) at the bedside are becoming increasingly common, but evidence is limited as to their potential for innovative clinical trial implementation. The objective of this study was to test the hypothesis that the IPCS could feasibly be used to automate recruitment and enrolment for a clinical trial.
In medical-surgical units, we used the IPCS to randomise, recruit and consent eligible subjects. For participants not interacting with IPCS study materials within 48 hours, study staff-initiated recruitment in-person. Eligible study population included all caregivers and any patients >6 years old admitted to medical-surgical units and oncology units September 2015 to January 2016.
randomisation assessed using between-group comparisons of patient characteristics; recruitment success assessed by rates of consent; paperless implementation using successful acquisition of electronic signature and email address. We used χ analysis to assess success of randomisation and recruitment.
Randomisation was successful (n=1012 randomised, p>0.05 for all between-group comparisons). For the subset of eligible, randomised patients who were recruited, IPCS-only recruitment (consented: 2.4% of n=213) was less successful than in-person recruitment (61.4% of n=87 eligible recruited, p<0.001). For those consenting (n=61), 96.7% provided an electronic signature and 68.9% provided email addresses.
Our results suggest that as a tool at the bedside, the IPCS offers key efficiencies for study implementation, including randomisation and collecting e-consent and contact information, but does not offer recruitment efficiencies. Further research could assess the value that interactive technologies bring to recruitment when paired with in-person efforts, potentially focusing on more intensive user-interface testing for recruitment materials.
NCT02491190.
床边交互式患者护理系统（IPCS）越来越普遍，但关于其在创新临床试验实施方面的潜力的证据有限。本研究的目的是检验以下假设，即 IPCS 可以有效地用于自动化临床试验的招募和入组。
在医疗外科病房，我们使用 IPCS 对合格的受试者进行随机分组、招募和同意。对于在 48 小时内未与 IPCS 研究材料互动的参与者，研究人员会亲自进行招募。合格的研究人群包括所有在医疗外科病房和肿瘤科病房住院的、年龄大于 6 岁的医护人员和患者。
通过比较组间患者特征评估随机化的效果；通过同意率评估招募成功率；通过成功获取电子签名和电子邮件地址评估无纸化实施情况。我们使用卡方检验评估随机化和招募的成功率。
我们的结果表明，作为床边的一种工具，IPCS 为研究实施提供了关键的效率，包括随机分组、收集电子同意书和联系信息，但不能提供招募效率。进一步的研究可以评估交互式技术在与面对面努力相结合时对招募的价值，可能需要对招募材料进行更深入的用户界面测试。
NCT02491190。
