Disability and quality of life 6 months following coronary artery bypass graft surgery (CABG) were found to be significantly improved by a brief intervention focused on patients’ expectations before surgery (PSY-HEART-I study). To generalize the results and their implications for the healthcare system, however, a large multicenter experiment was required to explore the therapeutic value of such an intervention. The purpose of the PSY-HEART-II trial was to determine if a preoperative psychological intervention aimed at adjusting patients’ expectations (EXPECT) can enhance outcomes 6 months after coronary artery bypass graft (CABG) surgery (with or without heart valve replacement). Standard of Care (SOC) and an emotional support intervention not focusing on expectations will be used as benchmarks for the EXPECT study (SUPPORT). N equal to 567 patients undergoing CABG surgery will be randomly assigned to receive either SOC alone, SOC and EXPECT, or SOC and SUPPORT in a 3-arm multicenter randomized, controlled, prospective trial (RCT). To compare EXPECT and SOC, patients will be randomly assigned to either EXPECT or SUPPORT, with a 3:1:1 fixed imbalance ratio. Both psychological treatments involve 2 in-person appointments (each lasting 50 minutes), 2 phone consultations (each lasting 20 minutes) in the week leading up to surgery, and 1 follow-up phone consultation 6 weeks after the operation. Baseline evaluations will take place between 3 and 10 days before surgery, on the day of surgery itself, after 4 to 6 days, and at the 6-month mark. Disability due to illness at 6 months post-surgery will be the study’s primary aim. Secondary outcomes include patients’ hopes, patients’ perceptions of their own condition, patients’ quality of life, their hospital stays, and their blood test values (eg, inflammatory parameters such as IL-6, IL-8, CRP). With enough participants, this massive multi-center experiment could confirm and generalize the PSY-HEART-I trial’s encouraging findings for the routine management of cardiac surgery patients, thereby prompting adjustments to treatment guidelines in heart surgery.
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