Preventing Delirium and Promoting Long-Term Brain Health: A Clinical Trial Design for the Perioperative Cognitive Enhancement (PROTECT) Trial

Article type: Research Article

Authors: Atkins, Kelly J.^{a; b; c; *} | Scott, David A.^{a; b} | Silbert, Brendan^{a; b} | Pike, Kerryn E.^d | Evered, Lis^{a; b; e}

Affiliations: [a] Department of Anaesthesia and Acute Pain Medicine, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia | [b] Department of Critical Care, Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia | [c] Turner Institute for Brain and Mental Health, Monash University, Clayton, Victoria, Australia | [d] Department of Psychology & Counselling, School of Psychology & Public Health, La Trobe University, Melbourne, Victoria, Australia | [e] Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA

Correspondence: [*] Correspondence to: Dr. Kelly Atkins, Department of Anaesthesia and Acute Pain, 41 Victoria Parade, Fitzroy, Victoria 3065, Australia. E-mail: kelly.atkins@svha.org.au.

Abstract: Background: Perioperative neurocognitive disorders (PND), including postoperative delirium (POD), are common in older adults and, for many, precipitate functional decline and/or dementia. Objective: In this protocol, we describe a novel multidisciplinary, multicomponent perioperative intervention that seeks to prevent or reduce POD and associated cognitive decline. Methods: We will conduct a prospective, single-blind, pragmatic, randomized-controlled trial to compare our tailored multi-disciplinary perioperative pathway against current standard of care practices. We will recruit a total of 692 elective surgical patients aged 65 years or more and randomize them in a 1:1 design. Our perioperative intervention targets delirium risk reduction strategies by emphasizing the importance of early mobilization, nutrition, hydration, cognitive orientation, sensory aids, and avoiding polypharmacy. To promote healthy behavior change, we will provide a tailored psychoeducation program both pre- and postoperatively, focusing on cardiovascular and psychosocial risks for cognitive and functional decline. Results: Our primary outcome is the incidence of any PND (encapsulating POD and mild or major postoperative neurocognitive disorder) at three months postoperative. Secondary outcomes include any incidence of POD or neurocognitive disorder at 12 months. A specialized delirium screening instrument, the Confusion Assessment Method (3D-CAM), and a neuropsychological test battery, will inform our primary and secondary outcomes. Conclusion: Delirium is a common and debilitating postoperative complication that contributes to the cognitive and functional decline of older adults. By adopting a multicomponent, multidisciplinary approach to perioperative delirium prevention, we seek to reduce the burden of delirium and subsequent dementia in older adults.

Keywords: Anesthesia and analgesia, cognition, delirium, dementia, healthy aging, perioperative medicine, prehabilitation, preventive medicine, rehabilitation

DOI: 10.3233/JAD-210438

Journal: Journal of Alzheimer's Disease, vol. 83, no. 4, pp. 1637-1649, 2021