Clinical trial NCT00896220: Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Keywords: chronic critical illness
mechanical ventilation
outcomes
weakness
quality of life
Critically Ill patients and their family caregiver
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Critical Care Trials Group
name: Ontario Ministry of Health and Long Term Care
name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-05-11
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill individuals who require mechanical ventilation for one week or greater and their primary family caregiver

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


Eligibility 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).

Primary outcomes:
measure: Functional Independence Measure (FIM) - ICU Survivor
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: Six Minute Walking Test (6MWT) - ICU Survivor
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Secondary outcomes:
measure: Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor
timeFrame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: Beck Depression Inventory-II (BDI-II) - ICU Survivor
timeFrame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: Impact of Event Scale (IES) - ICU Survivor
timeFrame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: Hospital mortality - ICU Survivor
timeFrame: 1 and 2 years post-ICU discharge
measure: Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor
timeFrame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: The Positive Affect Scale (PAS) - Family Caregivers
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: The Care-giving Impact Scale (CIS) - Family Caregivers
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: The Care-giving Assistance Scale (CAS) - Family Caregivers
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
measure: The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers
timeFrame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Margaret Herridge, MSc MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.