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
  Purpose

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

Condition
Critically Ill

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: April 2006
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896220

Contacts
Contact: Andrea Matte, RRT 416-340-3057 andrea.matte@uhn.on.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Andrea Matte, RRT    416-603-5967    andrea.matte@uhn.on.ca   
Principal Investigator: Margaret S. Herridge, MSc MD FRCPC MPH         
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Andrea Matte, RRT    416-603-5967    andrea.matte@uhn.on.ca   
Principal Investigator: Niall Ferguson, MD FRCPC MSc         
Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Neill Adhikari, MD       neil.adhikari@sunnybrook.ca   
Principal Investigator: Neill Adhikari, MD FRCPC MSc         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Sangeeta Mehta, MD       geeta.mehta@utoronto.ca   
Principal Investigator: Sangeeta Mehta, MD FRCPC         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Jan Friedrich, MD         
Principal Investigator: Jan Friedrich, PhD MD FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Critical Care Trials Group
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Margaret Herridge, MSc MD MPH University Health Network, Toronto
  More Information

Publications:
Responsible Party: Dr. Margaret Herridge, MSc MD FRCPC MPH, University Health Network
ClinicalTrials.gov Identifier: NCT00896220     History of Changes
Other Study ID Numbers: 06-0157-AE, IHP-94531
Study First Received: May 8, 2009
Last Updated: October 8, 2009
Health Authority: Canada: UHN Research Ethics Board

Keywords provided by University Health Network, Toronto:
chronic critical illness
mechanical ventilation
outcomes
weakness
quality of life
Critically Ill patients and their family caregiver

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014