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

NCT ID: NCT06445153

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2027-07-31

Brief Summary

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.

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.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control phase

Control phase: in this phase, all study patients receive the standard therapy of the respective study center.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Intervention with clinical decision support system

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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)

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

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

Exclusion Criteria

• Insufficient language skills
• Moribund patients

Study relatives

• Insufficient language skills
• No consent for data entry

Substudy of the Charité - University Berlin:

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BARMER

OTHER

Sponsor Role: collaborator

Technische Universität Berlin

OTHER

Sponsor Role: collaborator

Freie Universität Berlin

OTHER

Sponsor Role: collaborator

Universitätsklinik der Ruhr-Universität Bochum

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum

Bad Oeynhausen, Bochum, Germany

Site Status: RECRUITING

Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin

Berlin, , Germany

Site Status: RECRUITING

CARITAS Klinik Maria Heimsuchung

Berlin, , Germany

Site Status: RECRUITING

Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Spies, MD, Prof.

Role: CONTACT

claudia.spies@charite.de

+49 30 450 55 11 02

Facility Contacts

Vera von Dossow, MD, Prof.

Role: primary

vvondossow@hdz-nrw.de

05731 97-1128

Claudia Spies, MD, Prof.

Role: primary

claudia.spies@charite.de

+49 30 450 55 11 02

Thomas König, MD

Role: primary

Other Identifiers

Digi-POD

Identifier Type: -

Identifier Source: org_study_id