Evaluation of a Hospital Program to Prevent Postoperative Delirium in Older Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversitätsklinikum Hamburg-Eppendorf

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 volunteers

Qualifiers

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

Design model

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

720 Participants
are divided into 1 treatment group
Group A: Delirium prevention programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

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.
2

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

Locations

This trial has no locations.

Sponsors and contacts

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