The primary objective of the multi-center stepped-wedge cluster-randomized controlled trial ERIC is to evaluate the effects of a multi-component telemedicine-based intervention delivered by the ICU on the adherence to quality indicators (QI) in intensive care medicine compared to usual care. Critically ill patients treated on the interventional condition receive daily tele-medical rounds during their ICU stay. Further secondary objectives are to demonstrate whether the intervention improves patient outcomes 3 and 6 months post ICU discharge, compared to usual care.
Rationale: Survivors of critical illness frequently develop long-term mental, cognitive, and/or physical impairments summarized as Post Intensive Care Syndrome (PICS). On the national society level, Germany uses 10 core QIs that are evidence-based to improve treatment quality at ICUs. Objective: To investigate whether a tele-medical intervention delivered at ICU improves the adherence to established evidence-based QIs in intensive care medicine compared to the adherence at ICUs delivering usual care. Study design: ERIC is a stepped-wedge cluster-randomized controlled quality improvement trial with participating ICUs crossing over from usual care to a multifaceted e-health intervention. After the rollout, all recruiting sites will have implemented the experimental intervention for at least 4 months. Follow-up assessments on the patient-level at month 3 and 6 after ICU discharge (index stay) will be conducted in the outpatient or inpatient setting (dependent on the patient's health status). Study population: Critically ill patients covered by statutory health insurance treated at participating ICUs in Berlin and Brandenburg, Germany. It is planned to recruit 1431 study patients within 16 months. Intervention: Complex telemedicine-based intervention incorporating the use of e-health technologies (virtual care), supported by blended learning of ICU staff prior to the site's crossover. Comparison: Intensive care according to current practice. Endpoints: Eight co-primary endpoints will be specified. A primary efficacy endpoint is the adherence to a single QI in intensive care medicine (definition according to Kumpf O. et al., 2017) measured on a daily basis, on a patient-level. Sedation and delirium management in Frankfurt/Oder before and after implementation of the new form of care ERIC - (SeDelFIN) In this sub-project it should be evaluated how the implementation of the evidence-based standard for delirium, analgesia and pain management changes changed after the introduction of the new form of care. For this purpose, the patient files (which are available in paper form) of all patients who were admitted to the intensive care unit of the Department of Anaesthesiology, Intensive Care Medicine and Pain therapy at the Frankfurt/Oder Clinic (study center) were analyzed by Wilma Klink.
The control condition delivered at ICU is usual care.
The experimental complex intervention ERIC consists of daily tele-medicine based rounds at ICU. Tele-ICU is implemented after a blended learning program for ICU staff which will be completed prior to the site's crossover.
Sana Klinikum Lichtenberg
Berlin, Germany
Department of Anesthesiolgy and Operative Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Berlin, Germany
QI 'Daily multiprofessional and interdisciplinary clinical visits with documentation of daily goals'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
QI 'Management of sedation, analgesia, and delirium'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
QI 'Patient-adapted ventilation'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
QI 'Early weaning from invasive ventilation'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
QI 'Measures for infection management'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
QI 'Early enteral nutrition'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,463
Unfallkrankenhaus Berlin
Berlin, Germany
Maria Heimsuchung Caritas Klinik Pankow
Berlin, Germany
Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Berlin, Germany
Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau
Berlin, Germany
Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus
Berlin, Germany
Paul Gerhard Diakonie - Martin-Luther-Krankenhaus
Berlin, Germany
Klinikum Barnim Werner-Forßmann-Krankenhaus
Eberswalde, Germany
Klinikum Frankfurt (Oder)
Frankfurt (Oder), Germany
...and 3 more locations
QI 'Documentation of structured patient and family communications'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
QI 'Early mobilization'
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
Time frame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
All-cause mortality
Number of deaths from any cause within 6 months after enrolment including in-hospital mortality will be recorded (using hospital administrative records, electronic medical records, municipal personal records database and the 3- and 6-month follow-up with surrogates).
Time frame: Up to 6 months following the first study-related ICU admission
Mental Health Condition - Depression and Anxiety
The patient-reported symptom burden on anxiety and depression will be assessed by the paper-based Patient-Health-Questionnaire PHQ-4 at month 3 and 6. Higher total scores indicate higher impairment.
Time frame: 3 and 6 months after ICU discharge
Mental Health Condition - Post-traumatic Stress
Patient-reported symptom burden on post-traumatic stress will be assessed by the paper-based questionnaire Impact of Event Scale revised (IES-R) at month 6. Higher total scores indicate greater distress.
Time frame: 6 months after ICU discharge
Cognition - MiniCog
Cognitive functional outcome as assessed by the MiniCog test (2 tests: three-item recall task; clock-drawing task) at month 3 and 6. Higher scores indicate better cognitive functioning.
Time frame: 3 and 6 months after ICU discharge
Cognition - Animal Naming Test
Cognitive functional outcome as assessed by the Animal Naming test at month 3 and 6. Higher scores indicate better cognitive functioning.
Time frame: 3 and 6 months after ICU discharge
Physical Function - Timed Up & Go Test
Patient's physical function, walking ability and risk of fall as assessed by the Timed Up \& Go (TUG) test at month 3 and 6. Higher scores indicate a higher level of impairment.
Time frame: 3 and 6 months after ICU discharge
Physical Function - Hand grip strength test
Patient's muscle/ nerve function is assessed by the Hand grip strength (HGS) test (measured with a dynamometer, average strength \[in kg\] of three trials for the dominant hand) at months 3 and 6.
Time frame: 3 and 6 months after ICU discharge
Health-related quality of life
Patient's self-reported health-related quality of life as measured by the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L) Visual Analogue Scale (VAS) and the EQ-5D-5L descriptive system; the EQ-5D-5L VAS is a thermometer-like rating scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: 3 and 6 months after ICU discharge
Organ dysfunction
Number of patients with organ dysfunction as assessed by general practitioner or study personnel/ investigator at month 3 and 6.
Time frame: 3 and 6 months after ICU discharge
Pulmonary Function - Dyspnea
Self-perceived breathlessness as assessed by the Modified British Medical Research Council (mMRC) Dyspnea Scale at month 6. 5-point Likert scale \[range 1 to 5\] with a higher score indicating higher impairment.
Time frame: 6 months after ICU discharge
Outpatient ventilation
Duration \[in days\] of mechanical ventilation after discharge from the ICU
Time frame: Up to 6 months after ICU discharge
Patient-reported Functioning and Disability (WHO Disability Assessment Schedule).
Patient-reported General Disability Score as measured by the WHO Disability Assessment Schedule (WHODAS 2.0) for activity limitation and participation restriction, 12-item short version, self-administered questionnaire. The raw score is calculated by summing the values for each of the 12 questions. Higher scores indicate greater disability.
Time frame: 6 months after ICU discharge