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Table 1 Items from the World Health Organization Trial Registration Data Set

From: 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)

1 Primary registry and trial-identifying number: DRKS-ID, DRKS00013311
2 Date of registration in primary registry: 10 November 2017
3 Secondary identifying numbers: no
4 Sources of monetary or material support: Innovation Fund of the Federal Joint Committee (G-BA): VF16012
5 Primary sponsor: University Hospital Tübingen
6 Secondary sponsor(s): (to be found)
7 Contact for public queries: Prof. Dr med. Gerhard Eschweiler, Geriatric Center of the University Hospital Tübingen; PD. Dr med. Christine Thomas, Klinikum Stuttgart
8 Contact for scientific queries: Prof. Dr med. Dr phil. Michael Rapp, Social and Preventive Medicine, Potsdam University
9 Public title: PAWEL: Patient safety, cost-effectiveness and quality of life: reduction of delirium risk and post-operative cognitive dysfunction after elective procedures in the elderly
10 Scientific title: see 9
11 Countries of recruitment: Germany, Baden-Wuerttemberg
12 Health condition(s) or problem(s) studied: delirium, postoperative cognitive dysfunction (POCD)
13 Intervention(s): trans-sectoral multimodal perioperative intervention for elective surgical interventions vs treatment as usual (TAU)
14 Key inclusion criteria: patients older than 70 years undergoing an elective surgery (heart, thorax, vessels, proximal big joints and spinal cord, genitourinary, gastrointestinal, and general elective surgery procedures) with at least 60-min duration of anesthesia (cut-to-suture time)
Key exclusion criteria: emergency surgery, newly discovered severe dementia (red flag: Mini Mental State Examination (MMSE) < 15, Montreal Cognitive Assessment (MoCA) < 8) without caregiver holding power of attorney, 120 km of driving distance to the center, inability to consent due to decreased German language abilities, poor clinical prognosis (survival < 15 months)
15 Study type: stepped wedge cluster randomized design
16 Date of first enrolment: 20 November 2017
17 Target sample size: 1800 for the delirium risk score, 1500 thereof for comparison of intervention
18 Recruitment status: enrolling by invitation
19 Primary outcome(s): delirium prevalence, measured by daily delirium screening (I-Confusion Assessment Method-based scoring system for delirium severity (I-CAM-S)) over 7 days post surgery, as well as after 2 and 6 months; Nursing Delirium Screening Scale (NuDESC) on days 2 and 6 post surgery
20 Key secondary outcome(s): delirium duration as described in the primary outcome assessment. Prevalence of POCD 2 and 6 months after surgery as measured by a neuropsychological test battery (Montreal Cognitive Assessment (MoCA), digit span backwards and Trail Making Test A and B (TMT A and B)) as well as cognitive performance measured with the continuous nonstandardized test values of these scales. A cognitive deficit is defined as the presence of a test value ≤ 0.5 standard deviations, normalized for age, gender, and education, in one of these test procedures