Enhanced Recovery After Intensive Care (ERIC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2020-11-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ICU usual care

control condition

Group Type ACTIVE_COMPARATOR

ICU Usual Care

Intervention Type OTHER

The control condition delivered at ICU is usual care.

Intervention "ERIC"

intervention condition

Group Type EXPERIMENTAL

Tele-ICU

Intervention Type BEHAVIORAL

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.

Interventions

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ICU Usual Care

The control condition delivered at ICU is usual care.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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