Clinical trial NCT03671447: Enhanced Recovery After Intensive Care (ERIC)
Official title: Enhanced Recovery After Intensive Care (ERIC) - a Multi-Center Stepped Wedge Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: intensive care medicine
critical illness
post intensive care syndrome
e-health
tele-ICU
quality indicators (QIs) in intensive care medicine
German Innovation Fund
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Innovationsausschuss beim Gemeinsamen Bundesausschuss (G-BA), Berlin, Germany
name: Fraunhofer-Institut für Offene Kommunikationssysteme FOKUS, Berlin, Germany
name: BARMER
name: Klinik Ernst von Bergmann Bad Belzig gGmbH, Bad Belzig, Germany
name: Technische Universität Berlin
name: Ludwig-Maximilians - University of Munich
First posted: 2018-09-14
Enrollment: 1463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: QI 'Daily multiprofessional and interdisciplinary clinical visits with documentation of daily goals'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
measure: QI 'Management of sedation, analgesia, and delirium'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
measure: QI 'Patient-adapted ventilation'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
measure: QI 'Early weaning from invasive ventilation'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
measure: QI 'Measures for infection management'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
measure: QI 'Early enteral nutrition'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
measure: QI 'Documentation of structured patient and family communications'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
measure: QI 'Early mobilization'
timeFrame: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to 6 months following the first study-related ICU admission
measure: Mental Health Condition - Depression and Anxiety
timeFrame: 3 and 6 months after ICU discharge
measure: Mental Health Condition - Post-traumatic Stress
timeFrame: 6 months after ICU discharge
measure: Cognition - MiniCog
timeFrame: 3 and 6 months after ICU discharge
measure: Cognition - Animal Naming Test
timeFrame: 3 and 6 months after ICU discharge
measure: Physical Function - Timed Up & Go Test
timeFrame: 3 and 6 months after ICU discharge
measure: Physical Function - Hand grip strength test
timeFrame: 3 and 6 months after ICU discharge
measure: Health-related quality of life
timeFrame: 3 and 6 months after ICU discharge
measure: Organ dysfunction
timeFrame: 3 and 6 months after ICU discharge
measure: Pulmonary Function - Dyspnea
timeFrame: 6 months after ICU discharge
measure: Outpatient ventilation
timeFrame: Up to 6 months after ICU discharge
measure: Patient-reported Functioning and Disability (WHO Disability Assessment Schedule).
timeFrame: 6 months after ICU discharge
Other outcomes:
measure: Economic - Length of stay at intensive care unit
timeFrame: Up to 6 months
measure: Economic - Length of hospital stay
timeFrame: Up to 6 months
measure: Economic - Return to work
timeFrame: 3 and 6 months after ICU discharge
measure: Economic - Cost-effectiveness
timeFrame: 3 and 6 months after ICU discharge
Locations:
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Berlin
country: Germany
facility: Department of Anesthesiolgy and Operative Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Berlin
country: Germany
facility: Maria Heimsuchung Caritas Klinik Pankow
city: Berlin
country: Germany
facility: Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau
city: Berlin
country: Germany
facility: Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus
city: Berlin
country: Germany
facility: Paul Gerhard Diakonie - Martin-Luther-Krankenhaus
city: Eberswalde
country: Germany
facility: Klinikum Barnim Werner-Forßmann-Krankenhaus
city: Frankfurt (Oder)
country: Germany
facility: Klinikum Frankfurt (Oder)
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken
city: Potsdam
country: Germany
facility: Ernst von Bergmann Klinikum - Clinic for Anesthesiology and Operative Intensive Care Medicine
city: Potsdam
country: Germany
facility: Ernst von Bergmann Klinikum - Clinic for Emergency and Internal-Intensive Care Medicine
Study officials:
affiliation: Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
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, Wobker 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.
citation: 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.
citation: Adrion C, Weiss B, Paul N, Berger E, Busse R, Marschall U, Caumanns J, Rosseau S, Mansmann U, Spies C; ERIC study group. Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes. BMJ Open. 2020 Sep 25;10(9):e036096. doi: 10.1136/bmjopen-2019-036096.