Feasibility, acceptability, and preliminary estimates of a multimodal AKTIVER Heart Delirium Prevention Program in patients indicated for cardiac surgery: study protocol of a randomized controlled PREVENT POstoperative Delirium (PREVENT-POD) Pilot Study

Abstract

Abstract Background Postoperative delirium (POD) is a common complication in geriatric patients undergoing cardiac surgery. POD is associated with prolonged length of stay in the intensive care unit and hospital, increased mortality, institutionalization, distress, risk of cognitive impairment and dementia. The non-pharmacological, multimodal AKTIVER intervention from the multicenter PAWEL trial significantly reduced POD incidence and days with POD in older patients undergoing abdominal and orthopedic surgery. However, this positive effect on POD incidence has not yet been demonstrated in elderly patients undergoing cardiac surgery. Therefore, a specific AKTIVER Heart intervention with additional modules was developed. Methods In the randomized controlled PREVENT-POD pilot study, 60 patients aged 65 years or older undergoing elective cardiac surgery will be recruited and 2:1 randomized in either into the AKTIVER Heart intervention group (AKTIVER Heart) or treatment-as-usual plus (TAU+) group. In total, 40 patients will receive the non-pharmacological and modified AKTIVER Heart intervention, while the other 20 will receive TAU+ with preoperative education. The primary outcome is the feasibility and acceptability of the AKTIVER Heart intervention. Secondary outcomes include the preliminary estimates of the AKTIVER Heart on POD incidence, duration and severity, cognition, quality of life, sleep, treatment- and disease expectations, distress, depression, and anxiety symptoms. Discussion This randomized controlled pilot study aims to evaluate the feasibility and acceptability of the non-pharmacological, multimodal AKTIVER Heart intervention in elderly patients undergoing elective cardiac surgery. This trial is designed to provide evidence on acceptability and feasibility of the AKTIVER Heart, and to perform a larger, well-powered multicenter POD prevention trial in cardiac surgery. Trial registration German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00035091, Registered prospectively on November 4, 2024