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

PSYHEART-I是一项在心脏外科单位进行的单中心试验，显示术前心理干预能够改善心脏手术后6个月由心血管疾病引起的残疾。心理干预侧重于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，并于2019年开始。在所有研究中心启动后，冠状病毒危机开始了，研究进度下降，而每个纳入患者的成本增加。尽管存在这些并发症，我们预计在2021年10月之前纳入50%的预期患者。最初的PSY HEART-II申请计划进行42个月的研究，其中36个月获得了首次批准。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困难而延长18个月）。在意识到意想不到的问题后，我们联系了DFG，同意调整里程碑，并增加35%的案例付款。由于修改了学习计划和经费要求，有必要提出延期申请。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患者护理产生重要影响，同时也对Cochrane分析和治疗指南产生重要影响（这项单点研究已被纳入最近的Cochrane分析，并在印刷媒体和电视上获得了令人印象深刻的认可）。

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).