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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445153
• Other study ID #: Digi-POD
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: June 2024
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 55 11 02
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Germany	Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum	Bad Oeynhausen	Bochum
Germany	CARITAS Klinik Maria Heimsuchung	Berlin
Germany	Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin	Berlin
Germany	Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH	Berlin

Sponsors (5)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	BARMER, Freie Universität Berlin, Technische Universität Berlin, Universitätsklinik der Ruhr-Universität Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Postperative delirium- free days	Number of postoperative delirium- free days within 5 days postoperatively per patient	Up to five days
Secondary	Changes of Electroencephalography	Signals are measured by Electroencephalography Monitor.	Participants will be followed up until the end of the operation, an expected average of 60 minutes
Secondary	Blood pressure	Blood pressure is measured in millimeters of mercury. Drop in blood pressure, Digi-POD cutoff RR systolic below 20% of baseline from start of surgery to discharge ICU.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Pulse	Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions of the heart per minute.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Heart rhythm	Heart rhythm is measured by an electrocardiogram used to evaluate heart frequencies.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Heart rate	Heart rate is measured by an electrocardiogram used to evaluate the heart. Heart rate drop Digi-POD cutoff below 50 bpm from start of surgery to discharge ICU.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Oxygen saturation	Oxygen saturation is measured by pulse oximetry.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Amount of dexmedetomidine	If dexmedetomidine is administered by the attending physician, the information from the patient's dexmedetomidine medication chart is recorded.	Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.
Secondary	Therapeutic measures against postoperative delirium (POD)	Multicomponent/multimodal preventive measures to avoid POD are recorded by a questionnaire.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Team meetings on postoperative delirium (POD)	Multicomponent team meetings to discuss preventive measures to avoid POD will be recorded by a questionnaire.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Delirium incidence	Delirium incidence is measured with validated delirium scores.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Delirium duration	Delirium duration is measured in days	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Proportion of patients with adequate adherence	Proportion of patients with adequate (at least 4 out of 6 points) adherence to guidelines.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Proportion of patients with good adherence	Proportion of patients with good (at least 5 out of 6 points) adherence to guidelines	Up to 7 postoperative days
Secondary	Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.	Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.	Up to 7 postoperative days
Secondary	Guideline adherence	Percentage of guideline recommendations fulfilled per patient in the first 7 postoperative days.	Up to 7 postoperative days
Secondary	Number of POD-free days within 7 days	Number of POD-free days within 7 days is measured postoperatively per patient:in	Up to 7 postoperative days
Secondary	Delirium incidence within 7 days	Delirium incidence in patients who received delirium screening with validated delirium scores twice a day in at least two shifts (per-protocol analysis)	Up to 7 postoperative days
Secondary	Anxiety	Anxiety is measured by Faces Anxiety Scale	Up to 5 postoperative days
Secondary	Pain	Pain is measured with validated pain scores, scoring form 0 (no pain) to 10 (highest pain).	Up to 5 postoperative days
Secondary	Depth of sedation	Depth of sedation is measured with the Richmond Agitation-Sedation Scale (RASS)	Up to 5 postoperative days
Secondary	Functional performance	Functional performance is measured with the Glagow Coma Scale	Up to 5 postoperative days
Secondary	Concomitant medication	Concomitant medication is measured in dosis per day.	Up to 5 postoperative days
Secondary	Complications	Postoperative procedures/therapies and complications classified according to Clavien-Dindo	Up to 7 postoperative days
Secondary	Infection status	Infection status is measured by chart review	Up to 7 postoperative days
Secondary	Charlson comorbidity index (CCI)	The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Change in cognitive status	Cognitive status is measured with validated scores.	Up to 6 months
Secondary	Change in care level for BARMER patients	Care level is measured by chart review.	Up to 6 months
Secondary	Change in utilization of inpatient care		Up to 6 months
Secondary	Change in Patient-Reported Outcomes Measures (PROMs)	Patient-Reported Outcome Measures are recorded by PROM instruments.	Up to 3 months
Secondary	Change in Patient-Reported Experience Measures (PREMs)	Patient-Reported Experience Measures are recorded by PREM instruments.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Change in the result from the detailed geriatric assessment and the frailty scoring	Frailty is measured by a modified Fried score.	Up to 6 months
Secondary	Length of hospital stay	Length of hospital stay is measured in days.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Length of intensive care unit stay	Length of intensive care unit stay is measured in days.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Discharge type	Discharge type is taken from the medical record.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Length of stay in the recovery room	Length of stay in the recovery room is measured in hours.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Duration of surgery	Duration of surgery is measured in minutes.	Participants will be followed up until the end of operation, an expected average of 2 hours
Secondary	Duration of anesthesia	Duration of anesthesia is measured in minutes.	Participants will be followed up until the end of operation, an expected average of 2 hours
Secondary	Recommended therapies	Recommended therapies (physiotherapy, memory consultation, nutritional counseling) are measured by physical assessments.	Up to 6 months
Secondary	Incidence of Post Intensive Care Syndrome (PICS)	Incidence of Post Intensive Care Syndrome (PICS) is measured by a composite of psychological, cognitive and functional scores.	Up to 3 months
Secondary	Social data/Paragraph 21 data	Health economic data according to cost of patient care (The §21 dataset (diagnoses and operation-codes).	Up to 6 months
Secondary	All-cause "mortality"	Mortality is measured inhospital and during ths FU phase.	Up to 6 months
Secondary	Direct cost data	Direct care costs during inpatient treatment from the perspective of SHI (statutory health insurance).	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Follow-up costs	e.g. for outpatient/inpatient treatment, medication, remedies/aids and long-term care) from the perspective of statutory health insurance (SHI) and statutory long-term care insurance (LTCI)	Up to 6 months
Secondary	Utilization of benefits	Utilization of benefits from (statutory health insurance) (SHI) and statutory long-term care insurance (GPV) (in particular need for long-term care, outpatient/inpatient treatment)	Up to 6 months
Secondary	Personnel resources during the hospital stay	Personnel resources are measured by commitment time	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Investment costs	Costs are calculated with project data.	Participants will be followed up until the end of hospital stay, an expected average of 7 days
Secondary	Maintenance costs	Costs are calculated with project data.	Participants will be followed up until the end of hospital stay, an expected average of 7 days