Enhanced Recovery After Intensive Care (ERIC)
- Conditions
- Critical Illness
- Interventions
- Behavioral: Tele-ICUOther: ICU Usual Care
- Registration Number
- NCT03671447
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1463
- Age ≥ 18 years
- Expected to receive treatment in a medical or surgical ICU connected to the project for more than 24 hours
- Coverage by a German statutory health insurance company
- Written informed consent of patient or legal representative
• Age < 18 years
Institutional level:
Inclusion Criteria:
- Located in the Berlin/Brandenburg metropolitan region
- Adherence to general legal obligations to participate in the study funded by the German Innovation Fund and participate in the respective contracts.
- Adherence to cluster-randomization
Exclusion Criteria:
• No intensive care beds available
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention "ERIC" Tele-ICU intervention condition ICU usual care ICU Usual Care control condition
- Primary Outcome Measures
Name Time Method QI 'Daily multiprofessional and interdisciplinary clinical visits with documentation of daily goals' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Management of sedation, analgesia, and delirium' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Patient-adapted ventilation' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Early weaning from invasive ventilation' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Measures for infection management' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Early enteral nutrition' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Documentation of structured patient and family communications' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Early mobilization' From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
- Secondary Outcome Measures
Name Time Method All-cause mortality Up to 6 months following the first study-related ICU admission 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).
Mental Health Condition - Depression and Anxiety 3 and 6 months after ICU discharge 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.
Mental Health Condition - Post-traumatic Stress 6 months after ICU discharge 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.
Cognition - MiniCog 3 and 6 months after ICU discharge 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.
Cognition - Animal Naming Test 3 and 6 months after ICU discharge Cognitive functional outcome as assessed by the Animal Naming test at month 3 and 6. Higher scores indicate better cognitive functioning.
Physical Function - Timed Up & Go Test 3 and 6 months after ICU discharge 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.
Physical Function - Hand grip strength test 3 and 6 months after ICU discharge 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.
Health-related quality of life 3 and 6 months after ICU discharge 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).
Organ dysfunction 3 and 6 months after ICU discharge Number of patients with organ dysfunction as assessed by general practitioner or study personnel/ investigator at month 3 and 6.
Pulmonary Function - Dyspnea 6 months after ICU discharge 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.
Outpatient ventilation Up to 6 months after ICU discharge Duration \[in days\] of mechanical ventilation after discharge from the ICU
Patient-reported Functioning and Disability (WHO Disability Assessment Schedule). 6 months after ICU discharge 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.
Trial Locations
- Locations (13)
Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus
🇩🇪Berlin, Germany
Sana Klinikum Lichtenberg
🇩🇪Berlin, Germany
Ernst von Bergmann Klinikum - Clinic for Emergency and Internal-Intensive Care Medicine
🇩🇪Potsdam, Germany
Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau
🇩🇪Berlin, Germany
Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
Klinikum Barnim Werner-Forßmann-Krankenhaus
🇩🇪Eberswalde, Germany
Ernst von Bergmann Klinikum - Clinic for Anesthesiology and Operative Intensive Care Medicine
🇩🇪Potsdam, Germany
Paul Gerhard Diakonie - Martin-Luther-Krankenhaus
🇩🇪Berlin, Germany
Maria Heimsuchung Caritas Klinik Pankow
🇩🇪Berlin, Germany
Department of Anesthesiolgy and Operative Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Ruppiner Kliniken
🇩🇪Neuruppin, Germany
Klinikum Frankfurt (Oder)
🇩🇪Frankfurt (Oder), Germany