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

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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).