Salzmann, Stefan, Laferton, Johannes A. C., Shedden-Mora, Meike C., Horn, Nicole, Gaertner, Laura, Schroeder, Lara, Rau, Jorn, Schade-Brittinger, Carmen, Murmann, Kirsten, Rastan, Ardawan, Andrasi, Terezia B., Boening, Andreas, Salzmann-Djufri, Miriam, Loewe, Bernd, Brickwedel, Jens, Albus, Christian, Wahlers, Thorsten, Hamm, Alfons, Hilker, Lutz, Albert, Wolfgang, Falk, Volkmar, Zimmermann, Tanja, Ismail, Issam, Strauss, Bernhard, Doenst, Torsten, Schedlowski, Manfred, Moosdorf, Rainer and Rief, Winfried (2022). Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial. Am. Heart J., 254. S. 1 - 12. NEW YORK: MOSBY-ELSEVIER. ISSN 1097-6744

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Abstract

The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to 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). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center 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 (a 50 minute), 2 phone consultations (a 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surger y. Secondar y outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery. (Am Heart J 2022;254:1-11.)

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Salzmann, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Laferton, Johannes A. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shedden-Mora, Meike C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Horn, NicoleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaertner, LauraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schroeder, LaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rau, JornUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schade-Brittinger, CarmenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Murmann, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rastan, ArdawanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Andrasi, Terezia B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boening, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salzmann-Djufri, MiriamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loewe, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brickwedel, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Albus, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wahlers, ThorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hamm, AlfonsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hilker, LutzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Albert, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Falk, VolkmarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zimmermann, TanjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ismail, IssamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Strauss, BernhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doenst, TorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schedlowski, ManfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moosdorf, RainerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rief, WinfriedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-694103
DOI: 10.1016/j.ahj.2022.07.008
Journal or Publication Title: Am. Heart J.
Volume: 254
Page Range: S. 1 - 12
Date: 2022
Publisher: MOSBY-ELSEVIER
Place of Publication: NEW YORK
ISSN: 1097-6744
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
QUALITY-OF-LIFE; PREOPERATIVE EXPECTATIONS; HEALTH; QUESTIONNAIRE; RELIABILITY; DISABILITY; MORTALITY; PLACEBO; PERCEPTION; DEPRESSIONMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69410

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