Clinical trial NCT06445153: Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
Official title: Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Delirium
Keywords: Clinical decision support system, Delirium risk factors, recommendations, surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: BARMER
name: Technische Universität Berlin
name: Freie Universität Berlin
name: Universitätsklinik der Ruhr-Universität Bochum
First posted: 2024-06-06
Enrollment: 800
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Digi-POD is a multicenter, prospective, longitudinal intervention study in a before-and-after design with quantitative process analysis
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Guideline adherence
timeFrame: Up to five days
measure: Postperative delirium- free days
timeFrame: Up to five days
Secondary outcomes:
measure: Causes of delirium
timeFrame: Up to seven days
measure: Changes of Electroencephalography
timeFrame: Participants will be followed up until the end of the operation, an expected average of 60 minutes
measure: Blood pressure
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Pulse
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Heart rhythm
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Heart rate
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Oxygen saturation
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Amount of dexmedetomidine
timeFrame: Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.
measure: Therapeutic measures against postoperative delirium (POD)
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Team meetings on postoperative delirium (POD)
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Delirium incidence
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Delirium duration
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Proportion of patients with adequate adherence
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Proportion of patients with good adherence
timeFrame: Up to 7 postoperative days
measure: Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
timeFrame: Up to 7 postoperative days
measure: Guideline adherence
timeFrame: Up to 7 postoperative days
measure: Number of POD-free days within 7 days
timeFrame: Up to 7 postoperative days
measure: Delirium incidence within 7 days
timeFrame: Up to 7 postoperative days
measure: Anxiety
timeFrame: Up to 5 postoperative days
measure: Pain
timeFrame: Up to 5 postoperative days
measure: Depth of sedation
timeFrame: Up to 5 postoperative days
measure: Functional performance
timeFrame: Up to 5 postoperative days
measure: Concomitant medication
timeFrame: Up to 5 postoperative days
measure: Complications
timeFrame: Up to 7 postoperative days
measure: Infection status
timeFrame: Up to 7 postoperative days
measure: Charlson comorbidity index (CCI)
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Change in cognitive status I
timeFrame: Up to 6 months
measure: Change in cognitive status II
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Change in care level for BARMER patients
timeFrame: Up to 6 months
measure: Change in utilization of inpatient care
timeFrame: Up to 6 months
measure: Change in Patient-Reported Outcomes Measures (PROMs)
timeFrame: Up to 3 months
measure: Change in Patient-Reported Experience Measures (PREMs)
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Change in the result from the detailed geriatric assessment and the frailty scoring
timeFrame: Up to 6 months
measure: Length of hospital stay
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Length of intensive care unit stay
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Discharge type
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Length of stay in the recovery room
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Duration of surgery
timeFrame: Participants will be followed up until the end of operation, an expected average of 2 hours
measure: Duration of anesthesia
timeFrame: Participants will be followed up until the end of operation, an expected average of 2 hours
measure: Recommended therapies
timeFrame: Up to 6 months
measure: Incidence of Post Intensive Care Syndrome (PICS)
timeFrame: Up to 3 months
measure: Social data/Paragraph 21 data
timeFrame: Up to 6 months
measure: Social data
timeFrame: Up to 6 months
measure: All-cause "mortality"
timeFrame: Up to 6 months
measure: Direct cost data
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Follow-up costs
timeFrame: Up to 6 months
measure: Utilization of benefits
timeFrame: Up to 6 months
measure: Personnel resources during the hospital stay
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Investment costs
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
measure: Maintenance costs
timeFrame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum
state: Bochum
city: Berlin
country: Germany
facility: Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin
city: Berlin
country: Germany
facility: CARITAS Klinik Maria Heimsuchung
city: Berlin
country: Germany
facility: Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: