Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)

The project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care. Subprojects regarding delirium are implementes as well.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Other: Intervention with clinical decision support system

Detailed Description

Postoperative delirium (POD) is the most common post-operative complication in the 70+ age group, affecting approximately fifteen percent of elderly patients. POD is characterized by impaired attention, awareness, and cognitive function. Both patients and their families are severely affected by the effects of this condition. While symptoms of POD occur during hospitalization, they have a critical impact on post-hospitalization quality of life, dependency on long-term care, and life expectancy.

The overarching goal of the Digi-POD project consortium is to develop a digital decision support system that makes current evidence-based guideline recommendations for POD machine-readable and allows automated, real-time validation against clinical data.

Sub-projects such as a point prevalence analysis on the incidence of delirium on 2 days at the Charité and a staff survey conducted by Aktionsbündnis Patientensicherheit e.V. in all study centers accompany this study.

Further substudies initiated by Charité Universitätsmedizin Berlin:

Two substudies (one feasibility study and one acceptance study) will be conducted using the prototype of the Clinical Brain Protection (CBP) application in Digi-POD patients at Charité.

Interviews and a review of project documentation to analyze obstacles and solution strategies for implementing data security/information security will be organized by Fraunhofer Fokus. The results will be incorporated into the Data Security project report.

• Study Type: Interventional
• Enrollment (Actual): 845
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • CARITAS Klinik Maria Heimsuchung
  • Berlin, Germany
    • Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
  • Berlin, Germany, 13355
    • Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin
  • Bochum
    • Bad Oeynhausen, Bochum, Germany, 32545
      • Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Study patients:

Inclusion Criteria:

• Age ≥ 70 years
• Male and female patients
• Patients who are insured through statutory health insurance
• Patients capable of giving consent for inclusion: by the patient, preoperatively
• Patients under guardianship for inclusion: written declaration of consent by guardian
• Operation (elective)

Exclusion Criteria:

• Insufficient language skills
• Moribund patients

Study relatives

Inclusion Criteria:

• Age ≥ 18 years
• Male and female relatives
• Relatives capable of giving consent for inclusion

Exclusion Criteria:

• Insufficient language skills
• No consent for data entry

Substudy of the Charité - University Berlin:

Inclusion criteria:

- All inpatients ≥ 18 years of age who have undergone delirium screening with a validated delirium screening instrument

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control phase; Control phase: in this phase, all study patients receive the standard therapy of the respective study center.
Experimental: Intervention phase; In this phase, the intervention with Digi-POD is made available as Clinical Decision Support System. The intervention consists of providing patients, relatives and caregivers with Digi-POD decision support for the prevention of delirium and treatment decisions for delirium in accordance with the recommendations from the guidelines in addition to the standard therapy of the respective study center.	Other: Intervention with clinical decision support system; To this phase, patient data is automated and systematically analyzed in order to derive decision support based on current evidence and make it available to Digi-POD users (patients, relatives, nursing staff, doctors, other healthcare professionals).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Guideline adherence	Guideline adherence: proportion of guideline recommendations fulfilled per patient in the first five postoperative days. The guideline adherence rate up to postoperative day 5 (or earlier if the patient has already been discharged) is calculated as a simple division: Number of recommendations fulfilled by number of all recommendations (N=6). A guideline adherence rate of at least 4 out of 6 points (67%) per patient is considered clinically sufficient.	Up to five days
Postperative delirium- free days	Number of postoperative delirium- free days within 5 days postoperatively per patient.	Up to five days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Electroencephalography	Signals are measured by Electroencephalography Monitor.	Participants will be followed up until the end of the operation, an expected average of 60 minutes
Blood pressure	Blood pressure is measured in millimeters of mercury. Drop in blood pressure, Digi-POD cutoff RR systolic below 20% of baseline from start of surgery to discharge ICU.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Pulse	Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions of the heart per minute.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Heart rhythm	Heart rhythm is measured by an electrocardiogram used to evaluate heart frequencies.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Heart rate	Heart rate is measured by an electrocardiogram used to evaluate the heart. Heart rate drop Digi-POD cutoff below 50 bpm from start of surgery to discharge ICU.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Oxygen saturation	Oxygen saturation is measured by pulse oximetry.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Amount of dexmedetomidine	If dexmedetomidine is administered by the attending physician, the information from the patient's dexmedetomidine medication chart is recorded.	Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.
Therapeutic measures against postoperative delirium (POD)	Multicomponent/multimodal preventive measures to avoid POD are recorded by a questionnaire.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Team meetings on postoperative delirium (POD)	Multicomponent team meetings to discuss preventive measures to avoid POD will be recorded by a questionnaire.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Delirium incidence	Delirium incidence is measured with validated delirium scores.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Proportion of patients with adequate adherence	Proportion of patients with adequate (at least 4 out of 6 points) adherence to guidelines.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Proportion of patients with good adherence	Proportion of patients with good (at least 5 out of 6 points) adherence to guidelines	Up to 7 postoperative days
Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.	Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.	Up to 7 postoperative days
Guideline adherence	Percentage of guideline recommendations fulfilled per patient in the first 7 postoperative days.	Up to 7 postoperative days
Number of POD-free days within 7 days	Number of POD-free days within 7 days is measured postoperatively per patient:in	Up to 7 postoperative days
Delirium incidence within 7 days	Delirium incidence in patients who received delirium screening with validated delirium scores twice a day in at least two shifts (per-protocol analysis)	Up to 7 postoperative days
Anxiety	Anxiety is measured by Faces Anxiety Scale	Up to 5 postoperative days
Pain	Pain is measured with validated pain scores, scoring form 0 (no pain) to 10 (highest pain).	Up to 5 postoperative days
Depth of sedation	Depth of sedation is measured with the Richmond Agitation-Sedation Scale (RASS)	Up to 5 postoperative days
Functional performance	Functional performance is measured with the Glagow Coma Scale	Up to 5 postoperative days
Concomitant medication	Concomitant medication is measured in dosis per day.	Up to 5 postoperative days
Complications	Postoperative procedures/therapies and complications classified according to Clavien-Dindo	Up to 7 postoperative days
Infection status	Infection status is measured by chart review	Up to 7 postoperative days
Charlson comorbidity index (CCI)	The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in care level for BARMER patients	Care level is measured by chart review.	Up to 6 months
Change in utilization of inpatient care		Up to 6 months
Change in Patient-Reported Outcomes Measures (PROMs)	Patient-Reported Outcome Measures are recorded by PROM instruments.	Up to 3 months
Change in Patient-Reported Experience Measures (PREMs)	Patient-Reported Experience Measures are recorded by PREM instruments.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in the result from the detailed geriatric assessment and the frailty scoring	Frailty is measured by a modified Fried score.	Up to 6 months
Length of hospital stay	Length of hospital stay is measured in days.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Length of intensive care unit stay	Length of intensive care unit stay is measured in days.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Discharge type	Discharge type is taken from the medical record.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Length of stay in the recovery room	Length of stay in the recovery room is measured in hours.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Duration of surgery	Duration of surgery is measured in minutes.	Participants will be followed up until the end of operation, an expected average of 2 hours
Duration of anesthesia	Duration of anesthesia is measured in minutes.	Participants will be followed up until the end of operation, an expected average of 2 hours
Recommended therapies	Recommended therapies (physiotherapy, memory consultation, nutritional counseling) are measured by physical assessments.	Up to 6 months
Incidence of Post Intensive Care Syndrome (PICS)	Incidence of Post Intensive Care Syndrome (PICS) is measured by a composite of psychological, cognitive and functional scores.	Up to 3 months
Social data/Paragraph 21 data	Health economic data according to cost of patient care (The §21 dataset (diagnoses and operation-codes).	Up to 6 months
All-cause "mortality"	Mortality is measured inhospital and during ths FU phase.	Up to 6 months
Direct cost data	Direct care costs during inpatient treatment from the perspective of SHI (statutory health insurance).	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Follow-up costs	e.g. for outpatient/inpatient treatment, medication, remedies/aids and long-term care) from the perspective of statutory health insurance (SHI) and statutory long-term care insurance (LTCI)	Up to 6 months
Utilization of benefits	Utilization of benefits from (statutory health insurance) (SHI) and statutory long-term care insurance (GPV) (in particular need for long-term care, outpatient/inpatient treatment)	Up to 6 months
Personnel resources during the hospital stay	Personnel resources are measured by commitment time	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Investment costs	Costs are calculated with project data.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Maintenance costs	Costs are calculated with project data.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Causes of delirium	Causes of postoperative delirium- within 7 days postoperatively per patient.	Up to seven days
Delirium duration	Delirium duration is measured in days.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Change in cognitive status I	Cognitive status is measured with validated scores.	Up to 6 months
Change in cognitive status II	Cognitive status is measured with the MOCA in patients with positive and negative MiniCog.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Social data	Evaluation of social data (pseudonymised) only for patients with statutory BARMER insurance and only with the patient's written consent to the processing of social data.	Up to 6 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Freie Universität Berlin; Ruhr University of Bochum; Technische Universität Berlin; BARMER
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Actual): January 15, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Clinical decision support system, Delirium risk factors, recommendations, surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Investigative Techniques; Methods
• Other Study ID Numbers: Digi-POD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No