Sanchez 2019.

Study name	Patient safety, cost‐effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults‐study protocol for a stepped‐wedge cluster randomized trial (PAWEL Study)
Methods	Stepped‐wedge cluster randomised trial
Participants	1500 patients (≥70 years) undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures)
Interventions	Group 1: cross‐sectorial all‐encompassing multimodal delirium prevention and management approach Group 2: standard care
Outcomes	Primary outcome: delirium prevalence using the delirium screening (I‐Confusion Assessment Method‐based scoring system for delirium severity (I‐CAM)/CAM‐S)) [over 7 days after surgery and after 2 and 6 months, the Nursing Delirium Screening Scale (NuDESC) [(days 2 and 6 after surgery), a chart review at discharge applying the DSM‐V delirium criteria as a reference standard and the clinical evaluation. Secondary outcome(s): delirium duration as described in the primary outcome assessment; prevalence of POCD 2 and 6 months after surgery; and persistence of POCD after 12 months. The prevalence of POCD will be measured by the following neuropsychological test battery: the Montreal Cognitive Assessment (MoCA), the digit span backwards, the Trail Making Test A and B (TMT A and B), and cognitive performance measured with the continuous non standardised test values of these scales.
Starting date	November 2017
Contact information	Michael Rapp, michael.rapp@uni‐potsdam.de Department of Social and Preventive Medicine, University of Potsdam
Notes	German Clinical Trials Register Identifer: DRKS00013311 Status: not reported. Estimated completion date: December 2020