Presurgery optimization of patient’s expectations to improve outcome in heart surgery (The PSY-HEART-II trial): Extension

术前优化患者对改善心脏手术结果的期望（PSY-HEART-II 试验）：扩展

• 批准号: 387080568
• 负责人: Professor Dr. Winfried Rief, Ph.D.
• 金额: --
• 依托单位: Klinik für Herz- und thorakale Gefäßchirurgie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/387080568?language=en
• 关键词: Presurgery; optimization; patient; expectations; improve

PSYHEART-I was a monocentric trial in cardiac surgery units showing that a preoperative psychological intervention is able to improve disability caused by the cardiovascular condition 6 months after cardiac surgery. The psychological intervention focusses on the optimization of patient's expectations about course and outcome (EXPECT), and was compared to a psychological comparison group, and standard medical care. The following multicenter Clinical Trial PSY HEART-II was funded by the DFG, and started in 2019. After all study centers were initiated, the Corona crisis started, and the study progress was reduced, while costs per included patient increased. Despite these complications, we expect the inclusion of 50 % of anticipated patients until October 2021. The original PSY HEART-II application planned a 42 months study duration, and 36 months were funded with the first approval. This prolongation application applies for financing 24 months (6 months extension as originally planned, and 18 months due to Corona difficulties). After realizing the unexpected problems, we contacted the DFG and agreed on adapting the milestones, and increasing the case payments for 35 %. As a consequence of the modified study plans and financial requests, this application for prolongation became necessary. A successful finalizing of this study PSY HEART-II and confirmation of our hypotheses will lead to important implications for patient care in cardiac surgery, but also for Cochrane analyses and treatment guidelines (already the monosite study was included in a recent Cochrane analyses, and resulted in impressive recognition in print media and TV).

PSYHEART-I是一项在心脏外科单位进行的单中心试验，表明术前心理干预能够改善心脏手术后6个月心血管疾病引起的残疾。心理干预的重点是优化患者对过程和结果的期望（EXPECT），并与心理对照组和标准医疗护理进行比较。以下多中心临床试验PSY HEART-II由DFG资助，于2019年开始。在所有研究中心启动后，Corona危机开始，研究进度降低，而每位入组患者的成本增加。尽管有这些并发症，我们预计到2021年10月将纳入50%的预期患者。最初的PSY HEART-II申请计划了42个月的研究时间，第一次批准后资助了36个月。此延期申请适用于24个月的融资（原计划延长6个月，由于Corona困难延长18个月）。在意识到意外的问题后，我们联系了DFG，并同意调整里程碑，并将案例付款增加35%。由于修改了研究计划和财务要求，有必要申请延长。这项研究PSY HEART-II的成功完成和我们假设的确认将对心脏手术中的患者护理产生重要影响，也对科克伦分析和治疗指南产生重要影响（单中心研究已经被纳入最近的科克伦分析，并在印刷媒体和电视上获得了令人印象深刻的认可）。