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Enhanced Recovery After Intensive Care (ERIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671447
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Claudia Spies, 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.


Condition or disease Intervention/treatment Phase
Critical Illness Other: ICU Usual Care Behavioral: Tele-ICU Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1431 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhanced Recovery After Intensive Care (ERIC) - a Multi-Center Stepped Wedge Cluster-Randomized Controlled Trial
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : April 15, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: ICU usual care
control condition
Other: ICU Usual Care
The control condition delivered at ICU is usual care.

Experimental: Intervention "ERIC"
intervention condition
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.




Primary Outcome Measures :
  1. QI 'Daily multiprofessional and interdisciplinary clinical visits with documentation of daily goals' [ Time Frame: 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

  2. QI 'Management of sedation, analgesia, and delirium' [ Time Frame: 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

  3. QI 'Patient-adapted ventilation' [ Time Frame: 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

  4. QI 'Early weaning from invasive ventilation' [ Time Frame: 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

  5. QI 'Measures for infection management' [ Time Frame: 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

  6. QI 'Early enteral nutrition' [ Time Frame: 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

  7. QI 'Documentation of structured patient and family communications' [ Time Frame: 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

  8. QI 'Early mobilization' [ Time Frame: 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 :
  1. All-cause mortality [ Time Frame: 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).

  2. Mental Health Condition - Depression and Anxiety [ Time Frame: 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.

  3. Mental Health Condition - Post-traumatic Stress [ Time Frame: 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.

  4. Cognition - MiniCog [ Time Frame: 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.

  5. Cognition - Animal Naming Test [ Time Frame: 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.

  6. Physical Function - Timed Up & Go Test [ Time Frame: 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.

  7. Physical Function - Hand grip strength test [ Time Frame: 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.

  8. Health-related quality of life [ Time Frame: 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).

  9. Organ dysfunction [ Time Frame: 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.

  10. Pulmonary Function - Dyspnea [ Time Frame: 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.

  11. Outpatient ventilation [ Time Frame: Up to 6 months after ICU discharge ]
    Duration [in days] of mechanical ventilation after discharge from the ICU

  12. Patient-reported Functioning and Disability (WHO Disability Assessment Schedule). [ Time Frame: 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.


Other Outcome Measures:
  1. Economic - Length of stay at intensive care unit [ Time Frame: 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).

  2. Economic - Length of hospital stay [ Time Frame: 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).

  3. Economic - Return to work [ Time Frame: 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.

  4. Economic - Cost-effectiveness [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

• No intensive care beds available


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671447


Locations
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Germany
Sana Klinikum Lichtenberg
Berlin, Germany, 10365
Department of Anesthesiolgy and Operative Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
Maria Heimsuchung Caritas Klinik Pankow
Berlin, Germany, 13187
Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau
Berlin, Germany, 13589
Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus
Berlin, Germany, 14129
Paul Gerhard Diakonie - Martin-Luther-Krankenhaus
Berlin, Germany, 14193
Klinikum Barnim Werner-Forßmann-Krankenhaus
Eberswalde, Germany, 16225
Klinikum Frankfurt (Oder)
Frankfurt (Oder), Germany, 15236
Ruppiner Kliniken
Neuruppin, Germany, 16816
Ernst von Bergmann Klinikum - Clinic for Anesthesiology and Operative Intensive Care Medicine
Potsdam, Germany, 14467
Ernst von Bergmann Klinikum - Clinic for Emergency and Internal-Intensive Care Medicine
Potsdam, Germany, 14467
Sponsors and Collaborators
Charite University, Berlin, Germany
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
Investigators
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Study Director: Claudia Spies, MD, Prof. Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03671447    
Other Study ID Numbers: ERIC
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claudia Spies, Charite University, Berlin, Germany:
intensive care medicine
critical illness
post intensive care syndrome
e-health
tele-ICU
quality indicators (QIs) in intensive care medicine
German Innovation Fund
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes