背景:羟基脲是镰状细胞病(SCD)的一种基于证据的疾病修饰疗法,但未得到充分利用。将移动健康整合到镰状细胞病护理中以提高羟基脲利用率(meSH)多中心研究利用mHealth为患者和提供者提供有针对性的干预措施。SCD研究经常不足;SCD人群的招募策略并未得到广泛研究。意料之外的事件可能会对入学产生负面影响,使研究确保充分学习权责发生制的策略变得重要。
目的:本研究的目的是评估MESH研究中患者和提供者的入学障碍和修改后的招募策略对全球紧急情况的影响。
方法:提供者的招募时间预计为2个月,患者的招募时间为6个月。与患者和提供者一起使用的招募策略,新的招聘策略,和招募率进行了捕获和比较。记录招聘适应及其原因,负责招聘的研究人员完成了一份不限成员名额的9项问卷,引发了对招聘和使用策略的挑战。使用主题内容分析推断主题。
结果:7个研究中心的总招募包括89个提供者和293个患者。患者和提供者的研究接受率为85.5%(382/447)。患者拒绝参与的原因通常是缺乏时间和对研究的兴趣,虽然提供者大多因为自我感知的高水平SCD专业知识而拒绝,认为他们不需要干预。最初,招募涉及亲自邀请参加诊所访问(患者),员工会议(提供者),或在办公室(提供商)内。我们确定了几个重要的招聘挑战,包括(1)对研究缺乏兴趣,(2)缺乏人力资源,(3)招聘活动没有物理空间,(4)缺乏验证资格的文件。适应性策略对于缓解COVID-19大流行造成的入学中断至关重要。这些包括远程接近和同意(例如,远程医疗,电子邮件,和电话)供患者和提供者使用。此外,对于患者来说,通过简化注册程序来丰富招聘(例如,在没有提供者转诊的情况下直接接近患者)和多点触摸方法(即,用传单温暖的介绍,文本,和患者门户消息)。我们发现,患者招募率在面对面和适应性(虚拟多点触摸)方法之间相似(167/200,83.5%和126/143,88.1%,分别为;P=.23)。然而,对于供应商来说,当面招聘明显高于远程招聘(48/50,96%和41/54,76%,分别,P<.001)。
结论:我们发现,通过各种丰富的远程招聘策略,及时适应招聘策略可以确保较高的招聘率。方法的灵活性和减少参与者辅助注册的注册程序的负担。在涉及SCD患者及其提供者的研究中,继续确定有效的招募策略以及招募挑战的影响和导航非常重要。
背景:临床试验。政府NCT03380351;https://clinicaltrials.gov/study/NCT03380351。
■RR2-10.2196/16319。
BACKGROUND: Hydroxyurea is an evidence-based disease-modifying therapy for sickle cell disease (SCD) but is underutilized. The Integration of Mobile Health into Sickle Cell Disease Care to Increase Hydroxyurea Utilization (meSH) multicenter
study leveraged mHealth to deliver targeted interventions to patients and providers. SCD studies often underenroll; and recruitment strategies in the SCD population are not widely studied. Unanticipated events can negatively impact enrollment, making it important to
study strategies that ensure adequate
study accrual.
OBJECTIVE: The goal of this study was to evaluate enrollment barriers and the impact of modified recruitment strategies among patients and providers in the meSH
study in response to a global emergency.
METHODS: Recruitment was anticipated to last 2 months for providers and 6 months for patients. The recruitment strategies used with patients and providers, new recruitment strategies, and recruitment rates were captured and compared. To document recruitment adaptations and their reasons, study staff responsible for recruitment completed an open-ended 9-item questionnaire eliciting challenges to recruitment and strategies used. Themes were extrapolated using thematic content analysis.
RESULTS: Total enrollment across the 7 sites included 89 providers and 293 patients. The
study acceptance rate was 85.5% (382/447) for both patients and providers. The reasons patients declined participation were most frequently a lack of time and interest in research, while providers mostly declined because of self-perceived high levels of SCD expertise, believing they did not need the intervention. Initially, recruitment involved an in-person invitation to participate during clinic visits (patients), staff meetings (providers), or within the office (providers). We identified several important recruitment challenges, including (1) lack of interest in research, (2) lack of human resources, (3) unavailable physical space for recruitment activities, and (4) lack of documentation to verify eligibility. Adaptive strategies were crucial to alleviate enrollment disruptions due to the COVID-19 pandemic. These included remote approaching and consenting (eg, telehealth, email, and telephone) for patients and providers. Additionally, for patients, recruitment was enriched by simplification of enrollment procedures (eg, directly approaching patients without a referral from the provider) and a multitouch method (ie, warm introductions with flyers, texts, and patient portal messages). We found that patient recruitment rates were similar between in-person and adapted (virtual with multitouch) approaches (167/200, 83.5% and 126/143, 88.1%, respectively; P=.23). However, for providers, recruitment was significantly higher for in-person vs remote recruitment (48/50, 96% and 41/54, 76%, respectively, P<.001).
CONCLUSIONS: We found that timely adaptation in recruitment strategies secured high recruitment rates using an assortment of enriched remote recruitment strategies. Flexibility in approach and reducing the burden of enrollment procedures for participants aided enrollment. It is important to continue identifying effective recruitment strategies in studies involving patients with SCD and their providers and the impact and navigation of recruitment challenges.
BACKGROUND: ClinicalTrials.Gov NCT03380351; https://clinicaltrials.gov/study/NCT03380351.
UNASSIGNED: RR2-10.2196/16319.