aDivision of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.
Clin Trials. 2014 Apr;11(2):218-29. doi: 10.1177/1740774514521904. Epub 2014 Feb 26.
Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects.
We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury.
Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes.
PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination.
We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings.
Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.
在家庭和社区环境中实施的复杂非药物干预措施的随机试验，例如南加利福尼亚大学（USC）-Rancho Los Amigos 国家康复中心（RLANRC）压疮预防研究（PUPS），在以下方面存在独特的挑战：（1）参与者招募和保留；（2）干预措施的提供和一致性；（3）随机化和评估；（4）潜在的意外治疗效果。
我们描述了在实施 PUPS 中应对挑战所采用的方法。在这项随机对照试验中，我们正在评估一种复杂的预防干预措施在降低脊髓损伤患者中发生严重压疮的发生率和与发展相关的成本方面的疗效。
从 RLANRC 招募的脊髓损伤患者被分配到为期 12 个月的预防干预组或标准护理对照组。主要结局是严重压疮的发生率，次要结局包括溃疡相关手术、医疗费用和生活质量。这些结局在随机分组后 12 个月和 24 个月进行评估。此外，我们还在研究解释干预结果的中介机制。
PUPS 已成功实施，包括招募到 170 名目标样本量，确保干预方案的提供具有平均 90%的治疗依从率，以及实施评估计划。然而，实施过程中充满了挑战。为了达到招募目标，我们采取了一种针对服务不足、种族多样化人群的五管齐下的方法。在干预措施的实施过程中，我们增加了员工时间，以克服保留和遵守治疗的经济和文化障碍。为了确保治疗的一致性和可复制性，我们根据严格的计划监测了干预方案的实施。最后，我们克服了与（1）确定压疮的发生率/严重程度、（2）随机化不平衡以及（3）意外的潜在对照组污染相关的未预料到的评估和设计问题。
我们已经解决了在 PUPS 的招募、评估和干预阶段遇到的最艰巨的挑战。一些挑战和解决方案可能不适用于在其他环境中进行的试验。
克服挑战需要采取多方面的方法，包括个性化、灵活性和坚持性，以及实施必要的中途修正的能力。
