Enhanced Recovery after Intensive Care (ERIC): study protocol for a stepped-wedge cluster randomized controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes

Abstract

ABSTRACTIntroductionSurvival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there are 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- or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognized as post intensive care syndrome (PICS). There are evidence- 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 analysisThe protocol of a multicentre, pragmatic, stepped wedge cluster-randomized controlled, quality improvement trial is presented. During three predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a 1-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 8 QIs daily measured during the patient’s ICU stay, compared to 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 disseminationThis 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 journal and presented at conferences. Study findings will also be disseminated via the website (https://www.eric-projekt.de).Trial registration numberClinicalTrials.gov NCT03671447 (https://clinicaltrials.gov/ct2/show/NCT03671447, 22 August 2018)ARTICLE SUMMARYStrengths and limitations of this study▪Telemedicine-based care potentially improves the adherence to quality indicators (QIs) in intensive care medicine, which accelerate patient recovery and improve long-term outcomes after critical illness.▪ERIC is the first large-scale cluster-randomized controlled trial to be carried out in ICUs in Berlin and Brandenburg, Germany, comparing the clinical and cost effectiveness of a telehealth-based quality improvement intervention to standard of care.▪By employing a stepped-wedge design, this quality improvement study will allow each cluster to act as its own control and preserve the internal validity of the study, with a potential for confounding by secular trends.▪The nature of the intervention does not allow blinding of study personnel and eligible patients at ICUs and might be confronted with cross-contamination and staff turnover.▪ERIC allows getting a comprehensive evaluation from the patient’s perspective, healthcare staff and health economics and assessing its suitability to become standard of care.