Pre-surgery optimization of patients’ expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial - 06/12/22
, Johannes A.C. Laferton, PhD b, Meike C. Shedden-Mora, PhD c, d, Nicole Horn a, Laura Gärtner a, Lara Schröder a, Jörn Rau e, Carmen Schade-Brittinger e, Kirsten Murmann, PhD e, Ardawan Rastan, MD f, Térezia B. Andrási, MD f, Andreas Böning, MD g, Miriam Salzmann-Djufri, MD g, Bernd Löwe, MD d, Jens Brickwedel, MD h, Christian Albus, MD i, Thorsten Wahlers, MD PhD j, Alfons Hamm, PhD k, Lutz Hilker, MD l, Wolfgang Albert, MD m, Volkmar Falk, MD n, Tanja Zimmermann, PhD o, Issam Ismail, MD p, Bernhard Strauß, PhD q, Torsten Doenst, MD r, Manfred Schedlowski, PhD s, Rainer Moosdorf, MD f, Winfried Rief, PhD aAbstract |
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.
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Vol 254
P. 1-11 - décembre 2022 Retour au numéro
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