Main Content

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

Project information

The aim of the PSY-HEART II study is to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) is capable of improving long-term outcome after coronary artery bypass graft surgery with or without heart valve replacement compared to Standard of Care (SOC) and an attention control intervention.

In a 3-arm multi-center randomized, controlled, prospective trial (RCT) N=567 patients scheduled for heart surgery will be randomized to either a psychological preoperative intervention to optimize expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care/standard of care /SOC) only. 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 (à 50 min) and 2 phone consultations (à 20 min) during the week prior to surgery, and one booster session post-surgery (around 6 weeks later). The 4 assessment will take place at baseline (approx. 10 days before surgery), preoperative assessment (-1 day before surgery), approx. 4-6 after surgery and 6 months after surgery. Primary endpoint of the study will be patients’ disability scores 6 months after surgery. Secondary outcomes will be patients’ expectations, subjective illness beliefs, quality of life, anxiety and depression, physical activity, cardiac anxiety, optimism, pain, beliefs about medicine, rehospitalization, adverse events, left ventricular ejection fraction, treatment satisfaction, manipulation check, expected working ability and blood samples (e.g., catecholamines, cortisol, IL-6, IL-10, CRP). A multi-center trial with a large sample size is needed to generalize the results (and to review the promising results of PsyHeart I) and its implications for health care systems, and to better understand the pathways of action and implications for different clinical outcomes.

The aim of the PSY-HEART II study is to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) is capable of improving long-term outcome after coronary artery bypass graft surgery with or without heart valve replacement compared to Standard of Care (SOC) and an attention control intervention. In a 3-arm multi-center randomized, controlled, prospective trial (RCT) N=567 patients scheduled for heart surgery will be randomized to either a psychological preoperative intervention to optimize expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care/standard of care /SOC) only. 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 (à 50 min) and 2 phone consultations (à 20 min) during the week prior to surgery, and one booster session post-surgery (around 6 weeks later). The 4 assessment will take place at baseline (approx. 10 days before surgery), preoperative assessment (-1 day before surgery), approx. 4-6 after surgery and 6 months after surgery. Primary endpoint of the study will be patients’ disability scores 6 months after surgery. Secondary outcomes will be patients’ expectations, subjective illness beliefs, quality of life, anxiety and depression, physical activity, cardiac anxiety, optimism, pain, beliefs about medicine, rehospitalization, adverse events, left ventricular ejection fraction, treatment satisfaction, manipulation check, expected working ability and blood samples (e.g., IL-6, IL-10, CRP).

A multi-center trial with a large sample size is needed to generalize the results (and to review the promising results of PsyHeart I) and its implications for health care systems, and to better understand the pathways of action and implications for different clinical outcomes.

Current program status

recruitment period

Team

Collaboration

Funding