The impact of a multicomponent telemedicine-based intervention on quality of life in adults with respiratory failure requiring mechanical ventilation: protocol for a cluster stepped-wedge randomized clinical trial (Tele-Rehab MV Trial)

Abstract

Objective: To assess the impact of a multicomponent intervention on the health-related quality of life of patients with hypoxemic respiratory failure requiring invasive mechanical ventilation. Methods: A cluster stepped-wedge randomized clinical trial will be conducted in intensive care units across Brazil. Intensive care units with ≥ 8 beds and the capacity to admit patients with acute hypoxemic respiratory failure will be included. Within each intensive care unit, adult patients with acute hypoxemic respiratory failure requiring invasive mechanical ventilation, in whom SARS-CoV-2 infection is part of the differential diagnosis, will be enrolled. The intervention consists of a telemedicine-based quality improvement program focused on disability prevention and rehabilitation strategies, implemented during the patient’s intensive care unit stay, continued through ward admission, and extending up to 2 months post-hospital discharge. The primary outcome is health-related quality of life assessed using the EuroQol 5-Dimension 3-Level scale 90 days after discharge from the hospital. Secondary outcomes include rehospitalization within 30 days from hospital discharge, as well as all-cause mortality, anxiety, depression, cognitive impairment, new disabilities for instrumental activities of daily living, and return to work or studies 90 days after discharge from the hospital. Results: The study protocol has been approved by the research ethics committees of all participant institutions. It was registered at ClinicalTrials.gov (NCT06343545) before the first participant was included. We aim to disseminate the findings through conferences and peer-reviewed journals. Conclusion: The “Tele-Rehab MV trial” may provide further information on the role of early multicomponent interventions aimed at disability prevention and rehabilitation for critically ill patients with acute hypoxemic respiratory failure.