Digital decision support system to prevent postoperative delirium
Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
NA · Charite University, Berlin, Germany · NCT06445153
This study is testing a new digital tool to help doctors prevent confusion after surgery in older patients, specifically those aged 70 and up.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 4 sites (Bad Oeynhausen, Bochum and 3 other locations) |
| Trial ID | NCT06445153 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance patient safety by developing a digital clinical decision support system that implements evidence-based guidelines for preventing postoperative delirium (POD) in elderly patients. The system will automate real-time validation against clinical data to improve efficiency and reduce the workload in clinics. The study focuses on patients aged 70 and older who are undergoing elective surgery, as they are at a higher risk for POD. Accompanying subprojects will analyze the incidence of delirium and gather staff feedback across participating centers.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 70 and older who are scheduled for elective surgery and can provide consent.
Not a fit: Patients who are moribund or have insufficient language skills may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium, improving recovery and quality of life for elderly patients.
How similar studies have performed: Other studies have shown promise in using digital decision support systems for various medical conditions, indicating potential success for this novel approach in preventing postoperative delirium.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bad Oeynhausen, Bochum and 3 other locations
- Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum — Bad Oeynhausen, Bochum, Germany (RECRUITING)
- Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin — Berlin, Germany (RECRUITING)
- CARITAS Klinik Maria Heimsuchung — Berlin, Germany (RECRUITING)
- Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH — Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Claudia Spies, MD, Prof.
- Email: claudia.spies@charite.de
- Phone: +49 30 450 55 11 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Delirium, Clinical decision support system, Delirium risk factors, recommendations, surgery