Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN, USA.
Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.
Clin Trials. 2023 Oct;20(5):559-563. doi: 10.1177/17407745231167123. Epub 2023 Apr 12.
Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning.
We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients.
Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient.
We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research.
在严格的临床试验中测试医疗保健提供干预措施是改善患者护理的关键步骤，但进行多地点随机临床试验以测试护理提供干预措施的效果具有独特的挑战，需要有远见和规划。
我们在肿瘤临床研究联盟（National Cancer Institute Community Oncology Research Program 的研究基地）中进行了首个护理提供试验（A191402CD），该试验测试了两种不同决策辅助工具在支持前列腺癌治疗共同决策方面的有效性。我们的经验说明了护理提供研究人员在寻求测试改善患者体验的干预措施时所面临的挑战。
经验教训包括以下几点：集群随机设计引入了复杂性；工作流程中断可能会阻碍站点参与；循证方法可能并不总是足够。
我们的结论如下建议：评估可行性需要特别严格；必须利用关系和人际动态。我们的经验可能会为未来的护理提供研究提供信息。
