The Tele-Rehab MV Cluster Stepped-Wedge Randomized Clinical Trial

Hospital Israelita Albert Einstein1,916 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,916

Conditions

Acute Respiratory Failure

Interventions

Standard of CareBEHAVIORAL

Standard of Care provided by enrolling hospitals

Disability Prevention and RehabilitationBEHAVIORAL

The study intervention is an evidence-based, multicomponent program focused on disability prevention and rehabilitation strategies, implemented during the patient's ICU stay, continued through ward admission, and extending up to two months post-hospital discharge.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged ≥18 years 2. 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. 3. Need for invasive mechanical ventilation. Exclusion Criteria: 1. Severe underlying disease with a life expectancy of less than 3 months; 2. Absence of a responsible family member for cases of patients with communication difficulties (aphasia, severe cognitive impairment, non-native speakers of Portuguese); 3. Absence of telephone contact; 4. Participants already included in the study; 5. Unavailability to carry out telephone follow-ups.

Locations (20)

Hospital de Emergência Dr. Daniel Houly

Arapiraca, Alagoas, Brazil

Outcomes

Primary Outcomes

Quality of life

Health-related quality of life assessed by the Brazilian version of the 5-dimension, 3-level EuroQol scale (EQ-5D-3L)

Time frame: 90 days after hospital discharge

Secondary Outcomes

Mortality

All cause mortality

Time frame: From study enrollment (ICU admission) to 90 days after hospital discharge

Days alive and free of hospital

Days alive and free of hospital (not hospitalized)

Time frame: From study enrollment (ICU admission) to 90 days after hospital discharge

Rehospitalization

New hospitalization

Time frame: 30 days after hospital discharge

Return to work

Return to work or usual activities (work, study)

Time frame: 90 days after hospital discharge

Anxiety and Depression

Anxiety and depression measured according to Hospital Anxiety and Depression Scale

Time frame: 90 days after hospital discharge

New disability in instrumental activities of daily living

Incidence of new disabilities for instrumental activities of daily living assessed by the Lawton \& Brody scale

Time frame: 90 days after hospital discharge

Physical dependence

Prevalence of moderate, severe, or total physical disability assessed by the modified Barthel Index

Data from ClinicalTrials.gov

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