Enhanced Recovery After Intensive Care (ERIC)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhanced Recovery After Intensive Care (ERIC) - a Multi-Center Stepped Wedge Cluster-Randomized Controlled Trial

Conditions
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Critical Illness

Intervention / Treatment
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* Other: ICU Usual Care
* Behavioral: Tele-ICU


Participation Criteria
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Eligibility Criteria
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Patient Level: Inclusion Criteria: 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 Exclusion Criteria: • 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Stepped Wedge design with cluster-randomization of sites to 3 sequence groups (switching groups). Hereby, sites cross over to the intervention condition sequentially in a random order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICU usual care<br>control condition | Other: ICU Usual Care<br>* The control condition delivered at ICU is usual care.<br>|
| Experimental: Intervention ERIC<br>intervention condition | Behavioral: Tele-ICU<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. | 
| 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 | 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 | From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 6 months after ICU discharge | 
| Outpatient ventilation | Duration [in days] of mechanical ventilation after discharge from the ICU | 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. | 6 months after ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care medicine, critical illness, post intensive care syndrome, e-health, tele-ICU, quality indicators (QIs) in intensive care medicine, German Innovation Fund