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| Name | Class |
|---|---|
| BARMER | OTHER |
| Technische Universität Berlin | OTHER |
| Freie Universität Berlin | OTHER |
| Ruhr University of Bochum |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control phase | No Intervention | Control phase: in this phase, all study patients receive the standard therapy of the respective study center. | |
| Intervention phase | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention with clinical decision support system | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Postperative delirium- free days | Number of postoperative delirium- free days within 5 days postoperatively per patient. | Up to five days |
| Measure | Description | Time Frame |
|---|---|---|
| Causes of delirium | Causes of postoperative delirium- within 7 days postoperatively per patient. | Up to seven days |
| Changes of Electroencephalography | Signals are measured by Electroencephalography Monitor. |
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Study patients:
Inclusion Criteria:
Exclusion Criteria:
Study relatives
Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum | Bad Oeynhausen | Bochum | 32545 | Germany |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| OTHER |
Digi-POD is a multicenter, prospective, longitudinal intervention study in a before-and-after design with quantitative process analysis
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| Participants will be followed up until the end of the operation, an expected average of 60 minutes |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Guideline adherence | Percentage of guideline recommendations fulfilled per patient in the first 7 postoperative days. | Up to 7 postoperative days |
| 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 |
| 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 |
| Anxiety | Anxiety is measured by Faces Anxiety Scale | Up to 5 postoperative days |
| Pain | Pain is measured with validated pain scores, scoring form 0 (no pain) to 10 (highest pain). | Up to 5 postoperative days |
| Depth of sedation | Depth of sedation is measured with the Richmond Agitation-Sedation Scale (RASS) | Up to 5 postoperative days |
| Functional performance | Functional performance is measured with the Glagow Coma Scale | Up to 5 postoperative days |
| Concomitant medication | Concomitant medication is measured in dosis per day. | Up to 5 postoperative days |
| Complications | Postoperative procedures/therapies and complications classified according to Clavien-Dindo | Up to 7 postoperative days |
| Infection status | Infection status is measured by chart review | Up to 7 postoperative days |
| 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 |
| Change in cognitive status I | Cognitive status is measured with validated scores. | Up to 6 months |
| Change in cognitive status II | Cognitive status is measured with the MOCA in patients with positive and negative MiniCog. | Participants will be followed up until the end of hospital stay, an expected average of 7 days |
| Change in care level for BARMER patients | Care level is measured by chart review. | Up to 6 months |
| Change in utilization of inpatient care | Up to 6 months |
| Change in Patient-Reported Outcomes Measures (PROMs) | Patient-Reported Outcome Measures are recorded by PROM instruments. | Up to 3 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Recommended therapies | Recommended therapies (physiotherapy, memory consultation, nutritional counseling) are measured by physical assessments. | Up to 6 months |
| 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 |
| 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 |
| Social data | 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. | Up to 6 months |
| All-cause "mortality" | Mortality is measured inhospital and during ths FU phase. | Up to 6 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin | Berlin | 13355 | Germany |
| CARITAS Klinik Maria Heimsuchung | Berlin | Germany |
| Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH | Berlin | Germany |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |