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Patient safety, cost-effectiveness and quality of life: reduction of delirium risk and post-operative cognitive dysfunction (POCD) after elective procedures in the elderly

Patient safety, cost-effectiveness and quality of life: reduction of delirium risk and post-operative cognitive dysfunction (POCD) after elective procedures in the elderly - PAWEL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013311
Enrollment
1500
Registered
2017-11-23
Start date
2017-11-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F05.0 F05.1

Interventions

Group 1: The intervention implements a trans-sectoral multimodal delirium prevention and management approach, consisting of the following actions, applied to the individual centers after randomization
more than 20% of nurses receive advanced training (“delirium scout” training – 450 minutes teaching time)
and more than 10% receive expert level training (“delirium champion” training –900 minutes teaching time). Additionally, 70% of physicians receive an extra 90 minutes of training on delirium preventio

Sponsors

Geriatrisches Zentrum am Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: Elective surgery (heart, thorax, vessels, proximal big joints and spinal cord, genitourinary, gastrointestinal and general elective surgery procedures) with at least 60 minutes duration of surgery (cut-to-suture-time).

Exclusion criteria

Exclusion criteria: Emergency surgery, newly discovered severe dementia (Red flag: Mini Mental Status Test (MMST) < 15, Montreal Cognitive Assessment (MoCA) < 8) without authorization or legal guardian, 120 km of driving distance to the center, inability to consent due to decreased German language abilities, poor clinical prognosis (survival of less the 15 months).

Design outcomes

Primary

MeasureTime frame
Delirium prevalence, measured by daily delirium-screening (I-Confusion Assessment Method (I-CAM-S)) over 7 days surgery, as well as after 2 and 6 months, Nursing Delirium Screening Scale (NuDESC) on days 2 and 6 post surgery, and the clinical evaluation.

Secondary

MeasureTime frame
Delirium Duration as described in the prirmary Outcome assessment. Prevalence of POCD 2 and 6 months after surgery as measured by a neuropsychological test battery (Montreal Cognitive Assessment (MoCA), Trail Making Test A and B (TMT A and B) and digit span backwards) as well as cognitive performance measured with the continuous non-standardized 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. Persistance of POCD after 12 months. For baseline assessment: sociodemographic assessment, subjective memory impairment (SMI), anamnesis (incl. extended Charlson Comorbidity Index (CCI), the American Society of Anesthesiologists Physical Status classification (ASA), CHA2DS2-score, blood markers, delirium history), grip strength, Whisper and visual acuity test, Timed up and go (TUG), Patient Health Questionnaire 4 items (PHQ-4), EuroQol five dimensions questionnaire (EQ-5D-5L), 12-Item Short Form Survey (SF-12), Mini Nutritional Assessment Short Form (MNA-SF), Barthel Index, CSHA Clinical Frailty Scale, the Visual Analogue Scale (VAS), Pittsburgh Sleep Quality Index PSQI (Basic), STOP-BANG, Sniffin’ sticks 12, Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), German Zarit Burden Interview (G-ZBI), medication with anticholinergic drugs. For planned analyses: Patient Health Questionnaire 4 items (PHQ-4), EuroQol five dimensions questionnaire (EQ-5D-5L), 12-Item Short Form Survey (SF-12), Mini Nutritional Assessment Short Form (MNA-SF), Barthel Index, CSHA Clinical Frailty Scale, amount and duration of restraints, Nurses’ observation scale for geriatric patients (NOSGER II), Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), German Zarit Burden Interview (G-ZBI). For planned health-economic analyses: For two centers, hospital costs. For patients insured by AOK Baden-Württemberg: service costs of

Countries

Germany

Contacts

Public ContactGerhard Eschweiler

Geriatrisches Zentrum am Universitätsklinikum Tübingen

pawel@med.uni-tuebingen.de07071-2982684

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 22, 2026