An interventional study of Multicomponent delirium prevention program in Postoperative Delirium, Delirium Prevention and Multicomponent Care Program, sponsored by Universitätsklinikum Hamburg-Eppendorf. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Prevention
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.
EvaDel is a prospective, single-center, longitudinal implementation study evaluating a multicomponent program for the prevention of postoperative delirium in patients aged 65 years and older undergoing inpatient surgery at the University Medical Center Hamburg-Eppendorf.
The program includes preoperative assessment of delirium-related risk factors, including cognitive impairment, frailty, and malnutrition. Patients are assigned to a low-, intermediate-, or high-risk category. Depending on the individual risk profile, preventive measures may include patient and family education, 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 transfers, and reduction of potentially deliriogenic medication. A specialized delirium team supports patients and clinical staff.
All participants receive care according to the prevention processes established at the time of treatment. No separate control group is planned. As the program is implemented gradually in routine clinical practice, outcomes will be analyzed in relation to time since implementation began and to the documented degree of implementation.
Data are collected from medical records and standardized assessments before surgery, during the postoperative hospital stay, at discharge, and during follow-up up to three months after surgery. Assessments include postoperative delirium, cognitive function, frailty, nutritional status, functional independence, complications, and patient experience.
The primary analysis will examine whether postoperative delirium decreases with increasing implementation of the prevention program. Secondary analyses will evaluate cognitive, functional, and clinical outcomes, feasibility, and adherence to the individual prevention measures. Regression models will account for relevant baseline and perioperative risk factors. Exploratory analyses will also be performed within the predefined delirium risk groups.
The study hypothesis is that a higher degree of implementation will be associated with fewer postoperative delirium events and better postoperative cognitive, functional, and clinical outcomes.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 720 is above the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multicomponent delirium prevention program
Behavioral: Multicomponent delirium prevention program
* 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
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).
Time frame: postoperative days 1-5
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.
Time frame: 3 months postoperative
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.
Time frame: 3 months postoperative
Postoperative complications
Incidence of postoperative complications, newly diagnosed conditions, and additional hospital treatment, obtained from medical records and participant interviews.
Time frame: 30 days postoperative
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.
Time frame: from baseline (day 1) up to 30 days postoperatively.
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.
Time frame: from baseline (day 1) up to 30 days postoperatively
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 184 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 26 months is above that.
Counting every sponsor, half of 184 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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