Enhanced Recovery After Intensive Care (ERIC)

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671447
• Other study ID #: ERIC
• Status: Completed
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: November 17, 2020

Study information

• Verified date: April 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1463
• Est. completion date: November 17, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• ICU Usual Care
The control condition delivered at ICU is usual care.

Behavioral:
• Tele-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.

Locations

Country	Name	City	State
Germany	Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin	Berlin
Germany	Department of Anesthesiolgy and Operative Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin	Berlin
Germany	Maria Heimsuchung Caritas Klinik Pankow	Berlin
Germany	Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus	Berlin
Germany	Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau	Berlin
Germany	Paul Gerhard Diakonie - Martin-Luther-Krankenhaus	Berlin
Germany	Sana Klinikum Lichtenberg	Berlin
Germany	Unfallkrankenhaus Berlin	Berlin
Germany	Klinikum Barnim Werner-Forßmann-Krankenhaus	Eberswalde
Germany	Klinikum Frankfurt (Oder)	Frankfurt (Oder)
Germany	Ruppiner Kliniken	Neuruppin
Germany	Ernst von Bergmann Klinikum - Clinic for Anesthesiology and Operative Intensive Care Medicine	Potsdam
Germany	Ernst von Bergmann Klinikum - Clinic for Emergency and Internal-Intensive Care Medicine	Potsdam

Sponsors (7)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	BARMER, Fraunhofer-Institut für Offene Kommunikationssysteme FOKUS, Berlin, Germany, Innovationsausschuss beim Gemeinsamen Bundesausschuss (G-BA), Berlin, Germany, Klinik Ernst von Bergmann Bad Belzig gGmbH, Bad Belzig, Germany, Ludwig-Maximilians - University of Munich, Technische Universität Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Kastrup M, Tittmann B, Sawatzki T, Gersch M, Vogt C, Rosenthal M, Rosseau S, Spies C. Transition from in-hospital ventilation to home ventilation: process description and quality indicators. Ger Med Sci. 2017 Dec 19;15:Doc18. doi: 10.3205/000259. eCollection 2017. — View Citation

Kumpf O, Braun JP, Brinkmann A, Bause H, Bellgardt M, Bloos F, Dubb R, Greim C, Kaltwasser A, Marx G, Riessen R, Spies C, Weimann J, Wöbker G, Muhl E, Waydhas C. Quality indicators in intensive care medicine for Germany - third edition 2017. Ger Med Sci. 2017 Aug 1;15:Doc10. doi: 10.3205/000251. eCollection 2017. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic - Length of stay at intensive care unit	Patients will be followed for duration of stay. The total number of days spent in ICU will be assessed (inclusive of index ICU stay).	Up to 6 months
Other	Economic - Length of hospital stay	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).	Up to 6 months
Other	Economic - Return to work	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.	3 and 6 months after ICU discharge
Other	Economic - Cost-effectiveness	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.	3 and 6 months after ICU discharge
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Outpatient ventilation	Duration [in days] of mechanical ventilation after discharge from the ICU	Up to 6 months after ICU discharge
Secondary	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

External Links

•   Funding source body of study
•   Official German project website
•   Quality indicators in intensive care medicine for Germany - third edition 2017