Clinical trial NCT06343545: Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure
Official title: Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure in Patients With Suspected COVID-19
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: acute respiratory failure
rehabilitation
COVID-19
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster crossover randomized trial
Primary purpose: TREATMENT

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 in critically ill patients affected by hypoxemic acute respiratory failure with suspected COVID-19.

Detailed description: Patients with severe forms of hypoxemic acute respiratory failure have persistent symptoms after hospital discharge, which seem to be mediated mainly by the need for mechanical ventilation. One of the main etiologies of hypoxemic acute respiratory failure is still COVID-19 in its endemic form. According to the World Health Organization (WHO), approximately 10 to 20% of people affected by COVID-19 develop persistent symptoms (lasting more than 3 months) in a condition described as Long COVID \[1\]. These symptoms can affect multiple organ systems (including respiratory, cardiovascular, musculoskeletal and nervous systems) and health domains (physical and mental domains, for example). A systematic review identified more than 50 symptoms potentially associated with Long COVID, including fatigue, muscle weakness, cough, dyspnea, difficulty concentrating, anosmia, headache, joint pain, insomnia, and anxiety were the most frequently reported. Such findings are similar in broader populations, including those with other forms of hypoxemic acute respiratory failure.

Observational studies demonstrate a consistent association between Long COVID and negative impacts on functionality, quality of life, hospitalizations, and costs. Two cohort studies conducted in the United States with COVID-19 hospitalization survivors (whose sum totals more than 2700 participants) found 60-day rehospitalization rates greater than 15%. Notably, about 48% of participants in one of these studies were financially distressed by COVID-19.

Although the occurrence of prolonged post-COVID symptoms does not depend exclusively on the severity of the initial SARS-CoV-2 infection, patients who require hospitalization for severe acute COVID-19 are those who have a higher prevalence of Long COVID and intensity of disabilities. In a study of more than 1700 COVID-19 survivors in China, more severe COVID-19 cases were associated with a higher risk of persistent symptoms, reduced physical capacity, muscle weakness, reduced ability to diffuse carbon monoxide (a test that evaluates the oxygenation capacity of the lungs), and an impact on quality of life. In this population of severe cases, it is believed that the prolonged effects of SARS-CoV-2 infection are added to the physical, cognitive, and mental health sequelae typically associated with critical illness (resulting from organ dysfunctions and intensive treatments, for example), potentiating the impact on the long-term health of COVID-19 survivors.

In scenarios similar to those of severe COVID-19, such as sepsis and acute respiratory distress syndrome, the implementation of mechanical ventilation release bundles, screening and early rehabilitation while still in the hospital ward, the adequate transmission of continuity of care to primary care, and the provision of access to rehabilitation after hospital discharge have shown the potential to accelerate the recovery of people affected by sequelae related to critical illnesses. However, these findings are based on preliminary studies that do not confirm their benefit in a large sample and with adequate methodology. In the broadest sense, the early initiation of interventions is an essential aspect to improve outcomes. When added to the delay in defining the etiology of the hypoxemic acute respiratory condition, it is imperative that the measures be applied in an equitable manner in the case of suspected COVID-19 and maintained even if the final diagnosis is not COVID-19. It would be ethically questionable to withdraw a potentially beneficial intervention from an at-risk population merely because it is not COVID-19, given the immense impact of acute respiratory failure on long-term quality of life.

Given the current scenario in Brazil, with more than 36 million people with a history of SARS-CoV-2 infection, it is estimated that more than 1 million people have been affected by Long COVID. Given this magnitude of cases, it is likely that during the coming years, due to the sequelae of COVID-19, the demand on the Unified Health System (SUS) for physical and mental rehabilitation services will increase. In this imminent situation, it is essential to investigate effective and pragmatic strategies, such as those described above, aimed at preventing and rehabilitating sequelae related to Long COVID, especially in patients affected by severe forms of COVID-19. Thus, a randomized clinical trial, the gold standard for evaluating interventions, will have the potential to support public policies for post-COVID-19 rehabilitation with accurate and generalizable information to the Brazilian context. The inclusion of patients with a suspected, but not confirmed, condition will allow a greater generalization of the results and early initiation of intervention in patients with other equally relevant pathologies with similar potential benefits.

Therefore, we propose a process improvement implementation study, with a design based on the allocation of hospitals (clusters) in a sequential manner (stepped wedge), to evaluate whether the implementation of care bundles in intensive care units, wards and post-discharge is capable of improving the quality of life in patients admitted to the ICU with hypoxemic acute respiratory failure within 90 days after discharge hospital.

Eligibility criteria: Inclusion Criteria:

1. Age of at least 18 years
2. Need for ICU admission due to hypoxemic acute respiratory failure with suspected COVID-19
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.

Primary outcomes:
measure: Quality of life
timeFrame: 90 days after hospital discharge
Secondary outcomes:
measure: Mortality
timeFrame: 90 days
measure: Days alive and free of hospital
timeFrame: 90 days since intensive care unit admission
measure: Rehospitalization
timeFrame: 30 days after hospital discharge
measure: Return to work
timeFrame: 90 days after hospital discharge
measure: Anxiety and Depression
timeFrame: 90 days
measure: New disability
timeFrame: 90 days
measure: Disability
timeFrame: 90 days
measure: Clinical Status
timeFrame: 90 days
measure: Cognitive impairment
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Adriano Pereira
role: STUDY_CHAIR
References: