NCT Number: NCT06445153
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.
This study is active but is not currently recruiting participants.
Notify Me70 year and older
All sexes
Interventional
Not applicable
Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen, Bochum, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Study patients:
Inclusion criteria
Exclusion criteria
Study relatives
Inclusion criteria
Exclusion criteria
Substudy of the Charité - University Berlin:
Inclusion criteria
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).
Time frame: 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.
Time frame: Up to five days
Number of postoperative delirium- free days within 5 days postoperatively per patient.
Time frame: Up to seven days
Causes of postoperative delirium- within 7 days postoperatively per patient.
Time frame: Participants will be followed up until the end of the operation, an expected average of 60 minutes
Signals are measured by Electroencephalography Monitor.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Oxygen saturation is measured by pulse oximetry.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Delirium duration is measured in days.
Time frame: 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.
Time frame: Up to 7 postoperative days
Proportion of patients with good (at least 5 out of 6 points) adherence to guidelines
Time frame: Up to 7 postoperative days
Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
Time frame: Up to 7 postoperative days
Percentage of guideline recommendations fulfilled per patient in the first 7 postoperative days.
Time frame: Up to 7 postoperative days
Number of POD-free days within 7 days is measured postoperatively per patient:in
Time frame: 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)
Time frame: Up to 5 postoperative days
Anxiety is measured by Faces Anxiety Scale
Time frame: Up to 5 postoperative days
Pain is measured with validated pain scores, scoring form 0 (no pain) to 10 (highest pain).
Time frame: Up to 5 postoperative days
Depth of sedation is measured with the Richmond Agitation-Sedation Scale (RASS)
Time frame: Up to 5 postoperative days
Functional performance is measured with the Glagow Coma Scale
Time frame: Up to 5 postoperative days
Concomitant medication is measured in dosis per day.
Time frame: Up to 7 postoperative days
Postoperative procedures/therapies and complications classified according to Clavien-Dindo
Time frame: Up to 7 postoperative days
Infection status is measured by chart review
Time frame: 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.
Time frame: Up to 6 months
Cognitive status is measured with validated scores.
Time frame: 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.
Time frame: Up to 6 months
Care level is measured by chart review.
Time frame: Up to 6 months
Time frame: Up to 3 months
Patient-Reported Outcome Measures are recorded by PROM instruments.
Time frame: 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.
Time frame: Up to 6 months
Frailty is measured by a modified Fried score.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants will be followed up until the end of operation, an expected average of 2 hours
Duration of surgery is measured in minutes.
Time frame: Participants will be followed up until the end of operation, an expected average of 2 hours
Duration of anesthesia is measured in minutes.
Time frame: Up to 6 months
Recommended therapies (physiotherapy, memory consultation, nutritional counseling) are measured by physical assessments.
Time frame: Up to 3 months
Incidence of Post Intensive Care Syndrome (PICS) is measured by a composite of psychological, cognitive and functional scores.
Time frame: Up to 6 months
Health economic data according to cost of patient care (The §21 dataset (diagnoses and operation-codes).
Time frame: 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.
Time frame: Up to 6 months
Mortality is measured inhospital and during ths FU phase.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Personnel resources are measured by commitment time
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Costs are calculated with project data.
Time frame: Participants will be followed up until the end of hospital stay, an expected average of 7 days
Costs are calculated with project data.
Charite University, Berlin, Germany
Other
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