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

University Health Network, Toronto

Status: Unknown

Conditions: Critically Ill

Study type: Observational

Funder types: Other

Identifiers

NCT00896220

06-0157-AE

IHP-94531

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

500 participants in 1 patient group

ICU Survivors and Their Family Caregiver

Description:

ICU Survivors who required one week or more of mechanical ventilation during their critical illness and their primary family caregiver