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

NCT06445153 | Active Not Recruiting

• 1 other identifier: Digi-POD
• Study Type: interventional
• Target: 845
• Locations: 1 country
• Sites: 4

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.

Conditions

Postoperative Delirium

Keywords

Clinical decision support system, Delirium risk factors, recommendations, surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (50)

• Causes of delirium

  Up to seven days

• Changes of Electroencephalography

  Participants will be followed up until the end of the operation, an expected average of 60 minutes

• Blood pressure

  Participants will be followed up until the end of hospital stay, an expected average of 7 days

• Pulse

  Participants will be followed up until the end of hospital stay, an expected average of 7 days

• Heart rhythm

  Participants will be followed up until the end of hospital stay, an expected average of 7 days

Study Arms (2)

Control phase

NO INTERVENTION

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

Intervention phase

EXPERIMENTAL

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

Interventions

Intervention with clinical decision support system 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).

Intervention phase

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years
• Male and female patients
• Patients who are insured through statutory health insurance
• Operation (elective)

You may not qualify if:

• Insufficient language skills
• Moribund patients
• Study relatives
• Age ≥ 18 years
• Male and female relatives
• Insufficient language skills
• No consent for data entry
• Substudy of the Charité - University Berlin:
• \- All inpatients ≥ 18 years of age who have undergone delirium screening with a validated delirium screening instrument

Sponsors & Collaborators

• Ruhr University of Bochum: collaborator
• Charite University, Berlin, Germany: lead
• BARMER: collaborator
• Technische Universität Berlin: collaborator
• Freie Universität Berlin: collaborator

Study Sites (4)

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

Bad Oeynhausen, Bochum, 32545, Germany

Location

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

Berlin, 13355, Germany

Location

CARITAS Klinik Maria Heimsuchung

Berlin, Germany

Location

Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Methods

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Model Details: Digi-POD is a multicenter, prospective, longitudinal intervention study in a before-and-after design with quantitative process analysis

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 6, 2024
• Study Start: June 3, 2024
• Primary Completion: January 15, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)