Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers

Study Overview
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Brief Summary
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Advances in critical care medicine have dramatically improved the survival of critically ill patients requiring prolonged mechanical ventilation. However, there are no systematic follow-up, rehabilitation, or psychoeducational interventions for these vulnerable patients or their family caregivers who contribute to survivor recovery and rehabilitation. Major barriers to developing these programs for survivors of prolonged mechanical ventilation and their caregivers include the following: There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation. There is inadequate information about the needs of survivors of prolonged mechanical ventilation and their family caregivers across the trajectory of illness (i.e., from the ICU to the community). There is a poor understanding of the development of ICU-acquired muscle injury. Towards RECOVER is the very first study to identify survivors of prolonged mechanical ventilation who are at-risk for poor functional outcomes, to identify elements of the care-giving situation that put caregivers at risk for poor quality of life and mental health, to catalogue the rehabilitative needs of patients and family caregivers across the illness trajectory, and to evaluate the mechanism of critical illness associated muscle injury. The RECOVER Program consists of Four Phases: Phase I: Towards RECOVER Phase II: RECOVER development and pilot testing Phase III: RECOVER randomized controlled trial Phase IV: Long-term implementation of RECOVER

Official Title
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Towards RECOVER - Rehabilitation and Recovery in Survivors of Critical Illness. Long-Term Outcomes and Needs Assessment in ICU Survivors of Prolonged Mechanical Ventilation and Their Caregivers

Conditions
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Critically Ill

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 16 years of age. Mechanically ventilated for a minimum of one week in study ICU. Exclusion Criteria: Catastrophic Neurological Injury in the opinion of the attending intensivist (ex. Grade V SAH or massive CVA). Pre-existing Formal diagnosis of neuromuscular disease. Non-ambulatory prior to hospital or ICU admission. Anticipated death or withdrawal of life sustaining treatment within 48 hours. History of psychiatric illness with documented admission. Patient is not fluent in English. Documented discussion re: imminent withdrawal of life sustaining treatment. Lives greater than 300 km from referral centre. Patient no living at a fixed address. Physician refusal. Patient of SDM (substitute decision maker) refuses consent. No next of kin of SDM available (if patient unable to provide consent).

Ages Eligible for Study
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Minimum Age: 16 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU Survivors and Their Family Caregiver<br>ICU Survivors who required one week or more of mechanical ventilation during their critical illness and their primary family caregiver | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) - ICU Survivor |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| Six Minute Walking Test (6MWT) - ICU Survivor |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor |  | 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| Beck Depression Inventory-II (BDI-II) - ICU Survivor |  | 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| Impact of Event Scale (IES) - ICU Survivor |  | 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| Hospital mortality - ICU Survivor |  | 1 and 2 years post-ICU discharge | 
| Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor |  | 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| The Positive Affect Scale (PAS) - Family Caregivers |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| The Care-giving Impact Scale (CIS) - Family Caregivers |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| The Care-giving Assistance Scale (CAS) - Family Caregivers |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 
| The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers |  | 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic critical illness, mechanical ventilation, outcomes, weakness, quality of life, Critically Ill patients and their family caregiver