Thorac Cardiovasc Surg 2023; 71(S 01): S1-S72
DOI: 10.1055/s-0043-1761773
Monday, 13 February
Perioperative Risikoadjustierung

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

Authors

  • S. Salzmann

    1   Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Deutschland

  • J. Laferton

    2   Department of Medicine, Health and Medical University, Potsdam, Deutschland

  • M. Shedden-Mora

    3   Department of Psychology, Medical School Hamburg, Hamburg, Deutschland

  • N. Horn

    1   Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Deutschland

  • L. Gärtner

    1   Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Deutschland

  • L. Schröder

    1   Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Deutschland

  • J. Rau

    4   Coordination Center for Clinical Trials (KKS), University of Marburg, Marburg, Deutschland

  • C. Schade-Brittinger

    4   Coordination Center for Clinical Trials (KKS), University of Marburg, Marburg, Deutschland

  • K. Murmann

    4   Coordination Center for Clinical Trials (KKS), University of Marburg, Marburg, Deutschland

  • A. Rastan

    5   Department for Cardiovascular Surgery, Heart Center, Philipps University of Marburg, Marburg, Deutschland

  • T. Andrási

    5   Department for Cardiovascular Surgery, Heart Center, Philipps University of Marburg, Marburg, Deutschland

  • A. Böning

    6   Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Deutschland

  • M. Salzmann-Djufri

    6   Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Deutschland

  • B. Löwe

    7   Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg, Hamburg, Deutschland

  • J. Brickwedel

    8   Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Deutschland

  • C. Albus

    9   Department of Psychosomatics and Psychotherapy, Medical Faculty and University Hospital, Cologne, Deutschland

  • T. Wahlers

    10   Department of Cardiothoracic Surgery, University Hospital of Cologne, Cologne, Deutschland

  • A. Hamm

    11   Department of Physiological and Clinical Psychology/ Psychotherapy, University of Greifswald, Greifswald, Deutschland

  • L. Hilker

    12   Department of Cardiovascular Surgery, Clinic Karlsburg, Heart and Diabetes Center, Karlsburg, Deutschland

  • W. Albert

    13   Psychosomatics, German Heart Center Berlin, Berlin, Deutschland

  • T. Zimmermann

    14   Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hanover, Deutschland

  • I. Ismail

    15   Division of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hanover, Deutschland

  • B. Strauß

    16   Institute of Psychosocial Medicine, Psychotherapy, and Psychooncology, University Hospital Jena, Jena, Deutschland

  • T. Doenst

    17   Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Deutschland

  • M. Schedlowski

    18   Institute of Medical Psychology and Behavioral Immunobiology, University Clinic Essen, Essen, Deutschland

  • R. Moosdorf

    5   Department for Cardiovascular Surgery, Heart Center, Philipps University of Marburg, Marburg, Deutschland

  • W. Rief

    1   Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Deutschland
Further Information
 
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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.


No conflict of interest has been declared by the author(s).

Publication History

Article published online:
28 January 2023

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