Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers
NCT ID: NCT00896220
Last Updated: 2009-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2006-04-30
2012-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Mechanically ventilated for a minimum of one week in study ICU.
Exclusion Criteria
* 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).
16 Years
ALL
No
Sponsors
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Canadian Critical Care Trials Group
OTHER
Ontario Ministry of Health and Long Term Care
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University Health Network, Toronto
OTHER
Responsible Party
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University Health Network
Principal Investigators
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Margaret Herridge, MSc MD MPH
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Sunnybrook
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Jan Friedrich, MD
Role: primary
References
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Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
Cameron JI, Herridge MS, Tansey CM, McAndrews MP, Cheung AM. Well-being in informal caregivers of survivors of acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):81-6. doi: 10.1097/01.ccm.0000190428.71765.31.
Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
Cameron JI, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, dos Santos C, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Herridge MS; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. One-Year Outcomes in Caregivers of Critically Ill Patients. N Engl J Med. 2016 May 12;374(19):1831-41. doi: 10.1056/NEJMoa1511160.
Czerwonka AI, Herridge MS, Chan L, Chu LM, Matte A, Cameron JI. Changing support needs of survivors of complex critical illness and their family caregivers across the care continuum: a qualitative pilot study of Towards RECOVER. J Crit Care. 2015 Apr;30(2):242-9. doi: 10.1016/j.jcrc.2014.10.017. Epub 2014 Oct 30.
Other Identifiers
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IHP-94531
Identifier Type: -
Identifier Source: secondary_id
06-0157-AE
Identifier Type: -
Identifier Source: org_study_id
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