Critical Illness
Conditions
Keywords
intensive care medicine, critical illness, post intensive care syndrome, e-health, tele-ICU, quality indicators (QIs) in intensive care medicine, German Innovation Fund
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.
Interventions
OTHERICU Usual Care
The control condition delivered at ICU is usual care.
BEHAVIORALTele-ICU
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.
Sponsors
Innovationsausschuss beim Gemeinsamen Bundesausschuss (G-BA), Berlin, Germany
Fraunhofer-Institut für Offene Kommunikationssysteme FOKUS, Berlin, Germany
BARMER
Klinik Ernst von Bergmann Bad Belzig gGmbH, Bad Belzig, Germany
Technische Universität Berlin
Ludwig-Maximilians - University of Munich
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 '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 |
| 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 '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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Economic - Length of stay at intensive care unit | Up to 6 months | Patients will be followed for duration of stay. The total number of days spent in ICU will be assessed (inclusive of index ICU stay). |
| Economic - Cost-effectiveness | 3 and 6 months after ICU discharge | Health-related costs for standard care and supportive care will be estimated in Euros per patient per months. Data source will be GPs, hospital-electronic health records and health insurance data as well as publicly available data sources from the German reimbursement system. |
| Economic - Return to work | 3 and 6 months after ICU discharge | Employment status at 3 months and 6 months after hospital discharge (including e.g. return to work, change in duties or change in effectiveness) at 3 and 6 months. |
| Economic - Length of hospital stay | Up to 6 months | Patients will be followed for duration of hospital stay. The total number of days spent in a hospital will be assessed (inclusive of index ICU stay and index hospitalization). |
Countries
Germany
Outcome results
None listed