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

Not Applicable

Recruiting

• Conditions: Postoperative Delirium
• Interventions: Other: Intervention with clinical decision support system

• Registration Number: NCT06445153
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2024-05-23
• Study Start: 2024-06-03
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention phase	Intervention with clinical decision support system	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.

Primary Outcome Measures

Name	Time	Method
Guideline adherence	Up to five days	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.
Postperative delirium- free days	Up to five days	Number of postoperative delirium- free days within 5 days postoperatively per patient.

Secondary Outcome Measures

Name	Time	Method
Causes of delirium	Up to seven days	Causes of postoperative delirium- within 7 days postoperatively per patient.
Changes of Electroencephalography	Participants will be followed up until the end of the operation, an expected average of 60 minutes	Signals are measured by Electroencephalography Monitor.
Blood pressure	Participants will be followed up until the end of hospital stay, an expected average of 7 days	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.
Pulse	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
Heart rhythm	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Heart rhythm is measured by an electrocardiogram used to evaluate heart frequencies.
Heart rate	Participants will be followed up until the end of hospital stay, an expected average of 7 days	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.
Oxygen saturation	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Oxygen saturation is measured by pulse oximetry.
Amount of dexmedetomidine	Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.	If dexmedetomidine is administered by the attending physician, the information from the patient's dexmedetomidine medication chart is recorded.
Therapeutic measures against postoperative delirium (POD)	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Multicomponent/multimodal preventive measures to avoid POD are recorded by a questionnaire.
Team meetings on postoperative delirium (POD)	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Multicomponent team meetings to discuss preventive measures to avoid POD will be recorded by a questionnaire.
Delirium incidence	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Delirium incidence is measured with validated delirium scores.
Delirium duration	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Delirium duration is measured in days.
Proportion of patients with adequate adherence	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Proportion of patients with adequate (at least 4 out of 6 points) adherence to guidelines.
Proportion of patients with good adherence	Up to 7 postoperative days	Proportion of patients with good (at least 5 out of 6 points) adherence to guidelines
Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.	Up to 7 postoperative days	Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
Guideline adherence	Up to 7 postoperative days	Percentage of guideline recommendations fulfilled per patient in the first 7 postoperative days.
Number of POD-free days within 7 days	Up to 7 postoperative days	Number of POD-free days within 7 days is measured postoperatively per patient:in
Delirium incidence within 7 days	Up to 7 postoperative days	Delirium incidence in patients who received delirium screening with validated delirium scores twice a day in at least two shifts (per-protocol analysis)
Anxiety	Up to 5 postoperative days	Anxiety is measured by Faces Anxiety Scale
Pain	Up to 5 postoperative days	Pain is measured with validated pain scores, scoring form 0 (no pain) to 10 (highest pain).
Depth of sedation	Up to 5 postoperative days	Depth of sedation is measured with the Richmond Agitation-Sedation Scale (RASS)
Functional performance	Up to 5 postoperative days	Functional performance is measured with the Glagow Coma Scale
Concomitant medication	Up to 5 postoperative days	Concomitant medication is measured in dosis per day.
Complications	Up to 7 postoperative days	Postoperative procedures/therapies and complications classified according to Clavien-Dindo
Infection status	Up to 7 postoperative days	Infection status is measured by chart review
Charlson comorbidity index (CCI)	Participants will be followed up until the end of hospital stay, an expected average of 7 days	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.
Change in cognitive status I	Up to 6 months	Cognitive status is measured with validated scores.
Change in cognitive status II	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Cognitive status is measured with the MOCA in patients with positive and negative MiniCog.
Change in care level for BARMER patients	Up to 6 months	Care level is measured by chart review.
Change in utilization of inpatient care	Up to 6 months
Change in Patient-Reported Outcomes Measures (PROMs)	Up to 3 months	Patient-Reported Outcome Measures are recorded by PROM instruments.
Change in Patient-Reported Experience Measures (PREMs)	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Patient-Reported Experience Measures are recorded by PREM instruments.
Change in the result from the detailed geriatric assessment and the frailty scoring	Up to 6 months	Frailty is measured by a modified Fried score.
Length of hospital stay	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Length of hospital stay is measured in days.
Length of intensive care unit stay	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Length of intensive care unit stay is measured in days.
Discharge type	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Discharge type is taken from the medical record.
Length of stay in the recovery room	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Length of stay in the recovery room is measured in hours.
Duration of surgery	Participants will be followed up until the end of operation, an expected average of 2 hours	Duration of surgery is measured in minutes.
Duration of anesthesia	Participants will be followed up until the end of operation, an expected average of 2 hours	Duration of anesthesia is measured in minutes.
Recommended therapies	Up to 6 months	Recommended therapies (physiotherapy, memory consultation, nutritional counseling) are measured by physical assessments.
Incidence of Post Intensive Care Syndrome (PICS)	Up to 3 months	Incidence of Post Intensive Care Syndrome (PICS) is measured by a composite of psychological, cognitive and functional scores.
Social data/Paragraph 21 data	Up to 6 months	Health economic data according to cost of patient care (The §21 dataset (diagnoses and operation-codes).
Social data	Up to 6 months	Evaluation of social data (pseudonymised) only for patients with statutory BARMER insurance and only with the patient's written consent to the processing of social data.
All-cause "mortality"	Up to 6 months	Mortality is measured inhospital and during ths FU phase.
Direct cost data	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Direct care costs during inpatient treatment from the perspective of SHI (statutory health insurance).
Follow-up costs	Up to 6 months	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)
Utilization of benefits	Up to 6 months	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)
Personnel resources during the hospital stay	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Personnel resources are measured by commitment time
Investment costs	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Costs are calculated with project data.
Maintenance costs	Participants will be followed up until the end of hospital stay, an expected average of 7 days	Costs are calculated with project data.

Trial Locations

Locations (4)

Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Bochum, Germany

Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin; 🇩🇪 Berlin, Germany

CARITAS Klinik Maria Heimsuchung; 🇩🇪 Berlin, Germany

Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH; 🇩🇪 Berlin, Germany