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

Abstract

Introduction: Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients' long-term outcomes if adhered to.

Methods and analysis: The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient's ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.

Ethics and dissemination: This protocol was approved by the ethics committee of the Charité-Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).

Trial registration number: ClinicalTrials.gov Registry (NCT03671447).

Keywords: adult intensive & critical care; clinical trials; health economics; medical education & training; quality in health care; telemedicine.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: All authors report grants from the German Innovation Fund of the Federal Joint Committee (G-BA), during the conduct of the study. CS reports grants from Aridis Pharmaceutical, grants from B. Braun Melsungen AG, grants from Drägerwerk AG & Co. KGaA, grants from Grünenthal GmbH, grants from Infectopharm GmbH, grants from Sedana Medical, grants from Deutsche Forschungsgemeinschaft/German Research Foundation, grants from Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)/German Aerospace Center, grants from Einstein Stiftung Berlin/ Einstein Foundation Berlin, grants from European Society of Anaesthesiology, grants from Gemeinsamer Bundesausschuss/G-BA, grants from Inneruniversitäre Forschungsförderung/Inner University Grants, grants from Projektträger im DLR/Project Management Agency, grants from Stifterverband/Non-Profit Society Promoting Science and Education, grants from WHOCC, grants from Baxter Deutschland GmbH, grants from Biotest AG, grants from Cytosorbents Europe GmbH, grants from Edwards Lifesciences Germany GmbH, grants from Fresenius Medical Care, grants from Grünenthal GmbH, grants from Masimo Europe, grants from Medtronic GmbH, grants from Pfizer Pharma PFE GmbH, personal fees from Georg Thieme Verlag, grants from Dr. F. Köhler Chemie GmbH, grants from Sintetica GmbH, grants from European Commission, grants from Stifterverband für die deutsche Wissenschaft e.V. /Philips, grants from Stiftung Charité, outside the submitted work. In addition, CS has a patent 10 2014 215 211.9 pending, a patent application no. PCT/EP2015/067730 pending to Graft Gesellschaft von Architekten mbH, and a patent application no. PCT/EP2015/067731 pending to Graft Gesellschaft von Architekten mbH. BW reports personal fees from Orion Pharma, outside the submitted work.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Schematic illustration of the staggered rollout process and timeline applied in the ERIC project (after the decision to extend recruitment, including postponement of third crossover date (indicated as vertical dashed line)). Blue areas indicate intervention stage (telemedicine), grey areas control stage and the unshaded area indicates the post-ICU phase (displayed after LPFV). In each sequence group, a 3-month transition period at the end of the control condition is defined. Follow-up assessments (secondary outcomes) on the patient level 3 and 6 months after index ICU stay. Randomisation of 12 units occurred at a single time point prior to patient enrolment; one cluster of sequence group 3 withdrew informed consent prior to start of recruitment. ERIC, Enhanced Recovery after Intensive Care; FPFV, first patient first visit; ICU, intensive care unit; LPF(L)V, last patient first (last) visit.

Figure 2

The pillars of the ERIC intervention: an integrated approach to critical care and causal pathways. Due to the complexity of the comprehensive ICU telemedicine intervention with multiple co-dependent components, all pillars need to be effectively implemented to be successful. *Behavioural changes include process-related factors: planning and coordination of measures, risk-benefit evaluation, responsibilities and roles. Cultural barriers: lack of mobility culture, staff knowledge and critical care expertise, or prioritisation of therapeutic concepts. †Direct mechanisms are the mechanisms that might influence the QI adherence without a behavioural change; the identification of structural barriers that result in limitations (eg, no availability of an electronic medical record so far) might have an influence on the QI documentation and, thus, QI adherence. ERIC, Enhanced Recovery after Intensive Care; ICU, intensive care unit; QI, quality indicator.