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Critical IllnessNCT03671447

Enhanced Recovery After Intensive Care (ERIC)

A study testing Tele-ICU in people with Critical Illness, run by Charite University, Berlin, Germany at 13 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness
What is being tested?
Tele-ICU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,463 participants
Where
13 sitesGermany
Study dates
4 Sep 2018to 17 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • Age < 18 years
  • Institutional level:
  • No intensive care beds available

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Sana Klinikum Lichtenberg

    Berlin, 10365

  • Department of Anesthesiolgy and Operative Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

    Berlin, 12203

  • Unfallkrankenhaus Berlin

    Berlin, 12683

  • Maria Heimsuchung Caritas Klinik Pankow

    Berlin, 13187

  • Department of Anesthesiolgy and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau

    Berlin, 13589

  • Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus

    Berlin, 14129

  • Paul Gerhard Diakonie - Martin-Luther-Krankenhaus

    Berlin, 14193

  • Klinikum Barnim Werner-Forßmann-Krankenhaus

    Eberswalde, 16225

  • Klinikum Frankfurt (Oder)

    Frankfurt (Oder), 15236

  • Ruppiner Kliniken

    Neuruppin, 16816

  • Ernst von Bergmann Klinikum - Clinic for Anesthesiology and Operative Intensive Care Medicine

    Potsdam, 14467

  • Ernst von Bergmann Klinikum - Clinic for Emergency and Internal-Intensive Care Medicine

    Potsdam, 14467

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
ICU Usual Care, Tele-ICU
Keywords
intensive care medicine, critical illness, post intensive care syndrome, e-health, tele-ICU, quality indicators (QIs) in intensive care medicine, German Innovation Fund
Medical subject headings
Critical Illness, postintensive care syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICU Usual CareOther

    The control condition delivered at ICU is usual care.

  • Tele-ICUBehavioural

    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.

Study groups in NCT03671447
Study groupRoleWhat they receive
ICU usual careActive comparatorcontrol condition
Receives: Other: ICU Usual Care
Intervention "ERIC"Experimentalintervention condition
Receives: Behavioral: Tele-ICU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

  2. QI 'Management of sedation, analgesia, and delirium'

    The adherence [fulfilled yes/no] to this intra-hospital QI is daily assessed on a patient-level

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

  3. QI 'Patient-adapted ventilation'

    The adherence [fulfilled yes/no] to this intra-hospital QI is daily assessed on a patient-level

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

  4. QI 'Early weaning from invasive ventilation'

    The adherence [fulfilled yes/no] to this intra-hospital QI is daily assessed on a patient-level

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

  5. QI 'Measures for infection management'

    The adherence [fulfilled yes/no] to this intra-hospital QI is daily assessed on a patient-level

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

  6. QI 'Early enteral nutrition'

    The adherence [fulfilled yes/no] to this intra-hospital QI is daily assessed on a patient-level

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

  7. 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

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

  8. QI 'Early mobilization'

    The adherence [fulfilled yes/no] to this intra-hospital QI is daily assessed on a patient-level

    Measured: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.

Secondary outcomes (12)

  1. 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).

    Measured: Up to 6 months following the first study-related ICU admission

  2. 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.

    Measured: 3 and 6 months after ICU discharge

  3. 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.

    Measured: 6 months after ICU discharge

  4. 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.

    Measured: 3 and 6 months after ICU discharge

  5. 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.

    Measured: 3 and 6 months after ICU discharge

  6. 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.

    Measured: 3 and 6 months after ICU discharge

  7. 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.

    Measured: 3 and 6 months after ICU discharge

  8. 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).

    Measured: 3 and 6 months after ICU discharge

  9. Organ dysfunction

    Number of patients with organ dysfunction as assessed by general practitioner or study personnel/ investigator at month 3 and 6.

    Measured: 3 and 6 months after ICU discharge

  10. 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.

    Measured: 6 months after ICU discharge

  11. Outpatient ventilation

    Duration [in days] of mechanical ventilation after discharge from the ICU

    Measured: Up to 6 months after ICU discharge

  12. 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.

    Measured: 6 months after ICU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start4 Sep 2018
  3. Primary completion15 Apr 2020
  4. Study completion17 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
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)
Enrolment
1,463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671447
Sponsor's protocol ID
ERIC
Status last verified
Apr 2022
First submitted
22 Aug 2018
Last updated
4 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28794694

  • 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.

    PubMed 29308061

  • Adam MF, Grunow JJ, Edel A, Steinecke K, Schuster FS, Spies CD, Weiss B, Paul N. The impact of an intensive care telemedicine program on weaning from invasive ventilation: a secondary analysis of the ERIC trial. Crit Care. 2026 Aug 7;30(1):405. doi: 10.1186/s13054-026-06234-z.

    PubMed 42568095

  • Ribet Buse E, Grunow JJ, Spies CD, Weiss B, Paul N. Health-related quality of life correlates with patient-reported and proxy-reported disability in critical illness survivors: a secondary analysis of the ERIC trial. Crit Care. 2025 Apr 23;29(1):158. doi: 10.1186/s13054-025-05399-3.

    PubMed 40270036

  • Paul N, Ribet Buse E, Grunow JJ, Schaller SJ, Spies CD, Edel A, Weiss B. Prolonged Mechanical Ventilation in Critically Ill Patients: Six-Month Mortality, Care Pathways, and Quality of Life. Chest. 2025 Jul;168(1):106-118. doi: 10.1016/j.chest.2025.01.018. Epub 2025 Jan 27.

    PubMed 39880302

  • Paul N, Cittadino J, Krampe H, Denke C, Spies CD, Weiss B. Determinants of Subjective Mental and Functional Health of Critical Illness Survivors: Comparing Pre-ICU and Post-ICU Status. Crit Care Med. 2024 May 1;52(5):704-716. doi: 10.1097/CCM.0000000000006158. Epub 2024 Jan 8.

    PubMed 38189649

  • Spies CD, Paul N, Adrion C, Berger E, Busse R, Kraufmann B, Marschall U, Rosseau S, Denke C, Krampe H, Dahnert E, Mansmann U, Weiss B; ERIC Study Group. Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial. Intensive Care Med. 2023 Feb;49(2):191-204. doi: 10.1007/s00134-022-06949-x. Epub 2023 Jan 16.

    PubMed 36645446

  • Paul N, Cittadino J, Weiss B, Krampe H, Denke C, Spies CD. Subjective Ratings of Mental and Physical Health Correlate With EQ-5D-5L Index Values in Survivors of Critical Illness: A Construct Validity Study. Crit Care Med. 2023 Mar 1;51(3):365-375. doi: 10.1097/CCM.0000000000005742. Epub 2023 Jan 5.

    PubMed 36606801

  • 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.

    PubMed 32978185

Questions about this trial

What is this clinical trial studying?

A study testing Tele-ICU in people with Critical Illness, run by Charite University, Berlin, Germany at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671447, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.

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