Delirium Prevention, Multicomponent Care Program, Older Adults (60 - 85 Years Old), Postoperative Delirium
Conditions
Keywords
delirium, older adults, anesthesia, surgery
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMulticomponent 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
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
* Single-group, prospective, longitudinal interventional study * No parallel control group * All participants receive the multicomponent delirium prevention program * The intervention is implemented gradually within routine clinical care * Outcomes are compared across different stages and degrees of implementation * Implementation level is assessed based on documented delivery of key prevention measures
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Current schizophrenia * Active alcohol dependence or harmful alcohol use * Current drug abuse * severe intellectual disability * Preoperative delirium * Inability to understand the nature, significance, and implications of study participation or to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | postoperative days 1-5 | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional independence | 3 months postoperative | 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 | 3 months postoperative | 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 | 30 days postoperative | Incidence of postoperative complications, newly diagnosed conditions, and additional hospital treatment, obtained from medical records and participant interviews. |
Contacts
CONTACTCynthia Olotu, MD, Dr.
CONTACTLili Plümer, MD. Dr
PRINCIPAL_INVESTIGATORCynthia Olotu, MD. Dr.
University Medical Center Hamburg
Outcome results
None listed