About this trial
Postoperative delirium is a common complication in older adults undergoing surgery. It is characterized by an acute and fluctuating disturbance of attention, awareness, and thinking. Delirium may be associated with prolonged hospital stay, loss of independence, cognitive decline, complications, and increased need for care.
The University Medical Center Hamburg-Eppendorf has introduced a multicomponent care program to prevent postoperative delirium in patients aged 65 years and older. The program includes preoperative assessment of risk factors such as frailty, cognitive impairment, and malnutrition, as well as information for patients and relatives. Depending on the individual risk profile, preventive measures may include support with orientation, adequate hydration and nutrition, early mobilization, preservation of the sleep-wake cycle, use of glasses and hearing aids, avoidance of unnecessary room changes, and reduction of medications that may contribute to delirium. A specialized delirium team supports patients and clinical staff during the hospital stay.
EvaDel is a prospective study evaluating how patient care and clinical outcomes change while this delirium prevention program is gradually implemented in routine clinical practice. Participants will be followed from before surgery until three months after the operation. The study will assess the occurrence of postoperative delirium, cognitive function, independence in everyday activities, postoperative complications, and the extent to which the preventive measures were successfully implemented.
The study hypothesis is that a higher degree of implementation of the delirium prevention program will be associated with a lower rate of postoperative delirium and with better cognitive, functional, and clinical outcomes after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥65 years
Scheduled for or undergoing inpatient surgery at the study site
Able to provide written informed consent
Sufficient language proficiency to understand the study information and complete the study assessments
Disqualifiers
Current schizophrenia
Active alcohol dependence or harmful alcohol use
Current drug abuse
severe intellectual disability
Trial design
Sequential
Treatments tested in this trial
Multicomponent delirium prevention program
Behavioral* Preoperative screening for cognitive impairment, frailty, and malnutrition * Risk stratification into low-, intermediate-, or high-delirium-risk groups * Patient and family education about postoperative delirium and preventive measures * Individualized measures to support orientation, hydration, nutrition, mobility, and sleep-wake regulation * Provision of glasses and hearing aids when needed * Avoidance of unnecessary room transfers and potentially deliriogenic medications, where clinically feasible * Postoperative delirium screening during the hospital stay * Support by a specialized delirium team * Staff education on delirium prevention, recognition, and management * Stepwise implementation, with the delivered intervention components documented for each participant
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative delirium
Proportion of participants with at least one positive delirium assessment using the Nursing Delirium Screening Scale (NuDESC) or the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium (3D-CAM).
Secondary outcomes
Functional independence
Functional independence assessed using the Functional Independence Measure (FIM). A score of 18 to 126 points can be achieved. Higher scores indicate greater independence.
Cognitive function
Cognitive performance assessed using the 5-minute Montreal Cognitive Assessment (5-minute MoCA). A score of 0 to 15 points can be achieved. Higher scores indicate better cognitive performance.
Postoperative complications
Incidence of postoperative complications, newly diagnosed conditions, and additional hospital treatment, obtained from medical records and participant interviews.
Other outcomes
Feasibility of the delirium prevention program
Feasibility of integrating the multicomponent delirium prevention program into routine clinical care, assessed using documented completion and availability of the planned care processes.
Implementation of delirium prevention measures
Degree of implementation of key intervention components, including preoperative risk assessment, postoperative delirium screening, delivery of indicated preventive measures, and staff training.
Locations
Sponsors and contacts
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