Dickerson Suzanne S, Larkin Karen P, Loomis Dianne, Tyrpak Donna, Kwon Misol, Cha Youngran, Mohedat Heba, Dean Grace E
School of Nursing, University at Buffalo, The State University of New York, Buffalo, New York, United States of America.
Division of Sleep Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.
PLoS One. 2025 Aug 6;20(8):e0327806. doi: 10.1371/journal.pone.0327806. eCollection 2025.
COVID-19 was a barrier to meeting recruitment goals in clinical trials particularly for behavioral interventions requiring innovative and evolving strategies. This paper explores recruitment approaches prior to, during, and after the in-person recruitment pause in a longitudinal randomized controlled trial (RCT) in which cancer survivors received one of two interventions to self-manage insomnia. An explanatory case study method was used to investigate pre, during, and post COVID-19 recruitment during a longitudinal RCT. Data analysis included descriptive frequencies of enrollment approaches and outcomes obtained from the research team's weekly documented recruitment activities, and qualitative analysis of post-recruitment focus group of clinical partner experiences within the environmental context of the clinic settings. Team analysis included data triangulation between research team's recruitment data and clinical staff experiences, and times series analysis with explanation building with team consensus on the final product. A total of 136 heterogenous cancer survivor participants were recruited utilizing both in-person and virtual strategies with an 87.5% retention rate. Variability in success of recruitment approaches over time was demonstrated within the environmental contexts. Overall, in-person recruitment was the most effective strategy (55.1%) followed by passive strategies of print outreach and social media (36.8%). A creative and persistent research team was needed to achieve the recruitment target with a high retention rate. Recruiting in-person post COVID-19 was challenging due to clinical staff barriers. The explanatory case study method offers insight into the complex recruitment process and potential approaches that could be implemented for future public health insomnia treatment studies.
新冠疫情成为临床试验中实现招募目标的障碍,尤其是对于需要创新和不断发展策略的行为干预试验。本文探讨了一项纵向随机对照试验(RCT)中,在面对面招募暂停之前、期间和之后的招募方法。在该试验中,癌症幸存者接受两种自我管理失眠干预措施中的一种。采用解释性案例研究方法,调查纵向RCT中新冠疫情期间及前后的招募情况。数据分析包括从研究团队每周记录的招募活动中获得的招募方法和结果的描述性频率,以及在诊所环境背景下对临床合作伙伴招募后焦点小组经历的定性分析。团队分析包括研究团队招募数据与临床工作人员经验之间的数据三角测量,以及通过团队对最终结果达成共识进行解释构建的时间序列分析。共采用面对面和虚拟策略招募了136名异质性癌症幸存者参与者,保留率为87.5%。在不同环境背景下,招募方法的成功率随时间存在差异。总体而言,面对面招募是最有效的策略(55.1%),其次是印刷品宣传和社交媒体等被动策略(36.8%)。需要一个有创造力和坚持不懈的研究团队来实现高保留率的招募目标。由于临床工作人员的障碍,新冠疫情后进行面对面招募具有挑战性。解释性案例研究方法为复杂的招募过程以及未来公共卫生失眠治疗研究可采用的潜在方法提供了见解。