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

Charité University Medicine Berlin

Status: Enrolling

Conditions: Postoperative Delirium

Treatments: Other: Intervention with clinical decision support system

Study type: Interventional

Funder types: Other

Identifiers

NCT06445153

Digi-POD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

800 participants in 2 patient groups

Control phase

No Intervention group

Description:

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

Intervention phase

Experimental group

Description:

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.

Treatment:

Other: Intervention with clinical decision support system