Postoperative DeliriumEvaDelNCT07787832
Evaluation of a Hospital Program to Prevent Postoperative Delirium in Older Patients
A study testing Multicomponent delirium prevention program in people with Postoperative Delirium and Delirium Prevention, run by Universitätsklinikum Hamburg-Eppendorf.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Delirium Prevention, Multicomponent Care Program
- What is being tested?
- Multicomponent delirium prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lili Plümer, MD. Dr contact
About this study
Official title: Evaluation of the Quality Management Project 'Prevention of Post-operative Delirium in the Care of Older Patients' at the University Medical Centre Hamburg
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.
Read more
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.
Read the 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.
- Conditions
- Postoperative Delirium, Delirium Prevention, Multicomponent Care Program, Older Adults (60 - 85 Years Old)
- Being tested
- Multicomponent delirium prevention program
- Keywords
- delirium, older adults, anesthesia, surgery
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent delirium prevention programBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Delirium prevention program | Experimental | Multicomponent delirium prevention program Receives: Behavioral: Multicomponent delirium prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: postoperative days 1-5
Secondary outcomes (3)
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.
Measured: 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.
Measured: 3 months postoperative
Postoperative complications
Incidence of postoperative complications, newly diagnosed conditions, and additional hospital treatment, obtained from medical records and participant interviews.
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Olotu, MD. Dr., Principal investigator, University Medical Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787832
- Sponsor's protocol ID
- EvaDel
- Other IDs
- 2026-101793-BO-ff
- Acronym
- EvaDel
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality Management Project 'Prevention of Post-operative Delirium in the Care of Older Patients' at the University Medical Centre Hamburg
- ClinicalTrials.gov ID
- NCT07787832
- Acronym / sponsor ID
- EvaDel / EvaDel
- Conditions
- Postoperative Delirium, Delirium Prevention, Multicomponent Care Program, Older Adults (60 - 85 Years Old)
- Keywords
- delirium, older adults, anesthesia, surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Delirium prevention program | Experimental | Behavioral: Multicomponent delirium prevention programMulticomponent delirium prevention program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Current schizophrenia
- Active alcohol dependence or harmful alcohol use
- Current drug abuse
- severe intellectual disability
- Preoperative delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Delirium prevention program |
Primary outcome
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).
3 secondary outcomes
Functional independence
Time frame: 3 months postoperative
Cognitive function
Time frame: 3 months postoperative
Postoperative complications
Time frame: 30 days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lili Plümer, MD. Dr contact
Cynthia Olotu, MD. Dr. principal investigator
University Medical Center Hamburg
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent delirium prevention program in people with Postoperative Delirium and Delirium Prevention, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Olotu, MD, Dr. (+49 40 7410 52415, c.olotu@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: postoperative days 1-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.