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

• Conditions: Critically Ill

• Registration Number: NCT00896220
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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:

1. There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation.

2. 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).

3. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Status Verified: 2009-05
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-11
• Last Update Submitted: 2009-10-08
• Last Update Posted: 2009-10-09
• Primary Completion: 2010-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Older than 16 years of age.
• Mechanically ventilated for a minimum of one week in study ICU.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 Assistance Scale (CAS) - 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) - 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
The Care-giving Impact Scale (CIS) - Family Caregivers	7 days, 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
Impact of Event Scale (IES) - 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
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

Trial Locations

Locations (5)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada