Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit

Study Overview
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Brief Summary
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The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.

Official Title
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Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial

Conditions
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Acute Hypercapnic Respiratory Failure

Intervention / Treatment
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* Other: Bundle of comorbidities care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent form signed Acute hypercapnic respiratory failure defined as PaCO2 > 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU Exclusion Criteria: Age < 18 years old Known or suspected neuromuscular diseases Pregnancy Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose) Life expectancy < 3 months Confusion or major psychiatric illness Patient unable to be weaned from NIV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial (bundle of comorbidity care vs standard care)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Bundle of comorbidities care | Other: Bundle of comorbidities care<br>* Pulmonary function tests, blood gas analysis, transthoracic echocardiography, sleep study after stabilization of patient's index clinical condition, thus 1 month after hospital discharge<br>|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission | Hospital or ICU readmission | 1-year observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | Hospital Anxiety and Depression scale (0 to 21 points with 21 indicating higher levels of anxiety and depression) Saint George Questionnaire (0-100 with 100 indicating more limitations) Impact of dyspea on daily activities measured by mMRC (0 to IV with IV indication more impact of dyspnea) | Measured at regular 3, 6 and 12 months visits following patient's hospital discharge | 
| Cost-effectiveness | Costs related to unplanned emergency visits and hospital length of stay following readmission | 1-year observation |