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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canadian Critical Care Trials Group
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00896220
First received: May 8, 2009
Last updated: October 8, 2009
Last verified: May 2009

May 8, 2009
October 8, 2009
April 2006
October 2010   (final data collection date for primary outcome measure)
  • Functional Independence Measure (FIM) - ICU Survivor [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • Six Minute Walking Test (6MWT) - ICU Survivor [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00896220 on ClinicalTrials.gov Archive Site
  • Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor [ Time Frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) - ICU Survivor [ Time Frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • Impact of Event Scale (IES) - ICU Survivor [ Time Frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • Hospital mortality - ICU Survivor [ Time Frame: 1 and 2 years post-ICU discharge ] [ Designated as safety issue: No ]
  • Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor [ Time Frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • The Positive Affect Scale (PAS) - Family Caregivers [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • The Care-giving Impact Scale (CIS) - Family Caregivers [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • The Care-giving Assistance Scale (CAS) - Family Caregivers [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
  • The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers
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

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Critically ill individuals who require mechanical ventilation for one week or greater and their primary family caregiver

Critically Ill
Not Provided
ICU Survivors and Their Family Caregiver
ICU Survivors who required one week or more of mechanical ventilation during their critical illness and their primary family caregiver

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
October 2012
October 2010   (final data collection date for primary outcome measure)

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).
Both
16 Years and older
No
Contact: Andrea Matte, RRT 416-340-3057 andrea.matte@uhn.on.ca
Canada
 
NCT00896220
06-0157-AE, IHP-94531
No
Dr. Margaret Herridge, MSc MD FRCPC MPH, University Health Network
University Health Network, Toronto
  • Canadian Critical Care Trials Group
  • Ontario Ministry of Health and Long Term Care
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: Margaret Herridge, MSc MD MPH University Health Network, Toronto
University Health Network, Toronto
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP