Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial
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Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial. / Salzmann, Stefan; Laferton, Johannes A C; Shedden-Mora, Meike C; Horn, Nicole; Gärtner, Laura; Schröder, Lara; Rau, Jörn; Schade-Brittinger, Carmen; Murmann, Kirsten; Rastan, Ardawan; Andrási, Térezia B; Böning, Andreas; Salzmann-Djufri, Miriam; Löwe, Bernd; Brickwedel, Jens; Albus, Christian; Wahlers, Thorsten; Hamm, Alfons; Hilker, Lutz; Wolfgang, Albert; Volkmar, Falk; Zimmermann, Tanja; Ismail, Issam; Strauß, Bernhard; Doenst, Torsten; Schedlowski, Manfred; Moosdorf, Rainer; Rief, Winfried.
In: AM HEART J, Vol. 254, 12.2022, p. 1-11.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial
AU - Salzmann, Stefan
AU - Laferton, Johannes A C
AU - Shedden-Mora, Meike C
AU - Horn, Nicole
AU - Gärtner, Laura
AU - Schröder, Lara
AU - Rau, Jörn
AU - Schade-Brittinger, Carmen
AU - Murmann, Kirsten
AU - Rastan, Ardawan
AU - Andrási, Térezia B
AU - Böning, Andreas
AU - Salzmann-Djufri, Miriam
AU - Löwe, Bernd
AU - Brickwedel, Jens
AU - Albus, Christian
AU - Wahlers, Thorsten
AU - Hamm, Alfons
AU - Hilker, Lutz
AU - Wolfgang, Albert
AU - Volkmar, Falk
AU - Zimmermann, Tanja
AU - Ismail, Issam
AU - Strauß, Bernhard
AU - Doenst, Torsten
AU - Schedlowski, Manfred
AU - Moosdorf, Rainer
AU - Rief, Winfried
N1 - Copyright © 2022. Published by Elsevier Inc.
PY - 2022/12
Y1 - 2022/12
N2 - 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 (à 50 minute), 2 phone consultations (à 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 surgery. Secondary 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.
AB - 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 (à 50 minute), 2 phone consultations (à 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 surgery. Secondary 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.
U2 - 10.1016/j.ahj.2022.07.008
DO - 10.1016/j.ahj.2022.07.008
M3 - SCORING: Journal article
C2 - 35940247
VL - 254
SP - 1
EP - 11
JO - AM HEART J
JF - AM HEART J
SN - 0002-8703
ER -
