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NCT Number: NCT07787832

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

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Delirium Prevention Emergence Delirium Mental Disorders Multicomponent Care Program Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Older Adults (60 - 85 Years Old) Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: 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 outcomes

  1. Functional independence

    Time frame: 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.

  2. Cognitive function

    Time frame: 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.

  3. Postoperative complications

    Time frame: 30 days postoperative

    Incidence of postoperative complications, newly diagnosed conditions, and additional hospital treatment, obtained from medical records and participant interviews.

Other outcomes

  1. Feasibility of the delirium prevention program

    Time frame: from baseline (day 1) up to 30 days postoperatively.

    Feasibility of integrating the multicomponent delirium prevention program into routine clinical care, assessed using documented completion and availability of the planned care processes.

  2. Implementation of delirium prevention measures

    Time frame: from baseline (day 1) up to 30 days postoperatively

    Degree of implementation of key intervention components, including preoperative risk assessment, postoperative delirium screening, delivery of indicated preventive measures, and staff training.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Olotu, MD, Dr.

CONTACT

[email protected]

+49 40 7410 52415

Lili Plümer, MD. Dr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Evaluation of the Quality Management Project 'Prevention of Post-operative Delirium in the Care of Older Patients' at the University Medical Centre Hamburg

Acronym: EvaDel

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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