Evaluation of an Integrated Multicomponent Telemedicine-Based Intervention on Health-Related Quality of Life in Adults With Acute Respiratory Failure Requiring Mechanical Ventilation (Tele-Rehab MV Trial)
Overview
- Phase
- N/A
- Intervention
- Standard of Care
- Conditions
- Acute Respiratory Failure
- Sponsor
- Hospital Israelita Albert Einstein
- Enrollment
- 1916
- Locations
- 20
- Primary Endpoint
- Quality of life
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), the impact of specific bundles for disability prevention and early rehabilitation, focused on 3 domains (ICU, ward and post-discharge), on health-related quality of life and other long- and short-term outcomes, 90 days after hospital discharge, in critically ill patients affected by hypoxemic acute respiratory failure.
Detailed Description
Acute respiratory failure requiring invasive mechanical ventilation is associated with significant mortality rates. Furthermore, survivors often develop new physical, mental, and cognitive disabilities, as well as worsening clinical conditions, which can significantly impair their health-related quality of life. COVID-19 remains a notable cause of acute respiratory failure and long-term disabilities,6 with the added potential to cause persistent symptoms regardless of the infection's initial severity. Although the incidence of SARS-CoV-2-related respiratory failure has declined with the widespread adoption of vaccination, it persists as an endemic cause of pneumonia, particularly among patients with significant comorbidities, and is often part of the differential diagnosis in severe cases of acute hypoxemic respiratory failure. While bundles of interventions including analgesia optimization, sedation minimization, early mobilization, and delirium prevention, as well as screening for individuals at risk of new disabilities for early rehabilitation have been recommended to prevent disabilities in critical care patients, no large randomized clinical trial has yet demonstrated a significant impact on long-term health-related quality of life. Additionally, the burden of disability following critical illness is often associated with patients' inability to attend clinic-based follow-up, and telemedicine may serve as a tool to reduce healthcare inequalities. Accordingly, the primary objective of this cluster stepped-wedge randomized clinical trial is to assess the impact of a multicomponent telemedicine-based intervention on the health-related quality of life of patients with acute hypoxemic respiratory failure requiring invasive mechanical ventilation, evaluated 90 days after hospital discharge.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged ≥18 years
- •Admission to the ICU with hypoxemic acute respiratory failure in whom SARS-CoV-2 infection is part of the differential diagnosis will be enrolled. This does not imply that COVID-19 is the primary suspected cause, but rather that it is considered at least a possible (though not necessarily probable) diagnosis at the time of ICU admission.
- •Need for invasive mechanical ventilation.
Exclusion Criteria
- •Severe underlying disease with a life expectancy of less than 3 months;
- •Absence of a responsible family member for cases of patients with communication difficulties (aphasia, severe cognitive impairment, non-native speakers of Portuguese);
- •Absence of telephone contact;
- •Participants already included in the study;
- •Unavailability to carry out telephone follow-ups.
Arms & Interventions
Standard of Care
Standard of care provided by participating hospitals
Intervention: Standard of Care
Rehabilitation
An implementation bundle of measures to improve outcomes in intensive care unit, hospital, and after hospital discharge, including rehabilitation at home performed through telemedicine.
Intervention: Standard of Care
Rehabilitation
An implementation bundle of measures to improve outcomes in intensive care unit, hospital, and after hospital discharge, including rehabilitation at home performed through telemedicine.
Intervention: Disability Prevention and Rehabilitation
Outcomes
Primary Outcomes
Quality of life
Time Frame: 90 days after hospital discharge
Health-related quality of life assessed by the Brazilian version of the 5-dimension, 3-level EuroQol scale (EQ-5D-3L)
Secondary Outcomes
- Rehospitalization(30 days after hospital discharge)
- Return to work(90 days after hospital discharge)
- Mortality(From study enrollment (ICU admission) to 90 days after hospital discharge)
- Days alive and free of hospital(From study enrollment (ICU admission) to 90 days after hospital discharge)
- Anxiety and Depression(90 days after hospital discharge)
- New disability in instrumental activities of daily living(90 days after hospital discharge)
- Physical dependence(90 days after hospital discharge)
- Clinical Status(90 days after hospital discharge)
- Cognitive impairment(90 days after hospital discharge)