NCT03671447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,463

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

August 22, 2018

Last Update Submit

April 28, 2022

Conditions

Critical Illness

Keywords

intensive care medicinecritical illnesspost intensive care syndromee-healthtele-ICUquality indicators (QIs) in intensive care medicineGerman Innovation Fund

Outcome Measures

Primary Outcomes (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (12)

  • All-cause mortality

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

  • Mental Health Condition - Depression and Anxiety

    3 and 6 months after ICU discharge

  • Mental Health Condition - Post-traumatic Stress

    6 months after ICU discharge

  • Cognition - MiniCog

    3 and 6 months after ICU discharge

  • Cognition - Animal Naming Test

    3 and 6 months after ICU discharge

  • +7 more secondary outcomes

Other Outcomes (4)

  • Economic - Length of stay at intensive care unit

    Up to 6 months

  • Economic - Length of hospital stay

    Up to 6 months

  • Economic - Return to work

    3 and 6 months after ICU discharge

  • +1 more other outcomes

Study Arms (2)

ICU usual care

ACTIVE COMPARATOR

control condition

Other: ICU Usual Care

Intervention "ERIC"

EXPERIMENTAL

intervention condition

Behavioral: Tele-ICU

Interventions

ICU Usual CareOTHER

The control condition delivered at ICU is usual care.

ICU usual care
Tele-ICUBEHAVIORAL

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.

Intervention "ERIC"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Sana Klinikum Lichtenberg

Berlin, 10365, Germany

Location

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

Berlin, 12203, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Maria Heimsuchung Caritas Klinik Pankow

Berlin, 13187, Germany

Location

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

Berlin, 13353, Germany

Location

Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus

Berlin, 14129, Germany

Location

Paul Gerhard Diakonie - Martin-Luther-Krankenhaus

Berlin, 14193, Germany

Location

Klinikum Barnim Werner-Forßmann-Krankenhaus

Eberswalde, 16225, Germany

Location

Klinikum Frankfurt (Oder)

Frankfurt (Oder), 15236, Germany

Location

Ruppiner Kliniken

Neuruppin, 16816, Germany

Location

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

Potsdam, 14467, Germany

Location

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

Potsdam, 14467, Germany

Location

Related Publications (8)

  • 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.

    PMID: 28794694BACKGROUND

  • 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.

    PMID: 29308061BACKGROUND

  • 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.

    PMID: 40270036DERIVED

  • 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.

    PMID: 39880302DERIVED

  • 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.

    PMID: 38189649DERIVED

  • 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.

    PMID: 36645446DERIVED

  • 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.

    PMID: 36606801DERIVED

  • 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.

    PMID: 32978185DERIVED

Related Links

MeSH Terms

Conditions

Critical Illnesspostintensive care syndrome

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Claudia Spies, MD, Prof.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK

Study Record Dates

First Submitted

August 22, 2018

First Posted

September 14, 2018

Study Start

September 4, 2018

Primary Completion

April 15, 2020

Study Completion

November 17, 2020

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations

DE(13)