Pre-surgery Optimization of Patients’ Expectations to Improve Outcome in Heart Surgery: Study Protocol of the Randomized Controlled Multicenter PSY-HEART-II Trial

Background: Preoperative psychological preparation is gaining importance for cardiac surgery. The PSY-HEART-I trial indicated that a brief psychological intervention optimizing patients' expectations before heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement).

Method: EXPECT will be compared with Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multicenter randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (50 minutes), 2 phone consultations (20 minutes) during the week prior to surgery, and one booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approximately 3 to 10 days before surgery, preoperatively the day before surgery, 4 to 6 days later, and 6 months after surgery. This trial is funded by the DFG (German Research Foundation; PI W. Rief, DFG Ri-574/29–1 and Ri-574/29–2).

Results: The study's primary endpoint will be patients’ illness-related disability 6 months after surgery. Secondary outcomes will be patients’ expectations, subjective illness beliefs, quality of life, anxiety, depression, length of hospital stay and blood sample parameters (e.g., biomarkers such as IL-6, IL-8, CRP, NT-proBNP).

Conclusion: This large multicenter trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, strengthen the importance of a multi-professional team, and stimulate revisions of treatment guidelines in heart surgery.

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Artikel online veröffentlicht:
28. Januar 2023