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

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

Study Overview

• Status: Unknown
• Conditions: Critically Ill

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Jan Friedrich, MD
      • Principal Investigator: Jan Friedrich, PhD MD FRCPC
    • Toronto, Ontario, Canada, M5G 1X5
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Sangeeta Mehta, MD; Email: geeta.mehta@utoronto.ca
      • Principal Investigator: Sangeeta Mehta, MD FRCPC
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook
      • Contact: Neill Adhikari, MD; Email: neil.adhikari@sunnybrook.ca
      • Principal Investigator: Neill Adhikari, MD FRCPC MSc
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto Western Hospital
      • Contact: Andrea Matte, RRT; Phone Number: 416-603-5967; Email: andrea.matte@uhn.on.ca
      • Principal Investigator: Niall Ferguson, MD FRCPC MSc
    • Toronto, Ontario, Canada, M5G 2N2
      • Recruiting
      • Toronto General Hospital
      • Contact: Andrea Matte, RRT; Phone Number: 416-603-5967; Email: andrea.matte@uhn.on.ca
      • Principal Investigator: Margaret S. Herridge, MSc MD FRCPC MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Independence Measure (FIM) - ICU Survivor	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Six Minute Walking Test (6MWT) - ICU Survivor	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor	3 months, 6 months, 12 months and 24 months post-ICU discharge
Beck Depression Inventory-II (BDI-II) - ICU Survivor	3 months, 6 months, 12 months and 24 months post-ICU discharge
Impact of Event Scale (IES) - ICU Survivor	3 months, 6 months, 12 months and 24 months post-ICU discharge
Hospital mortality - ICU Survivor	1 and 2 years post-ICU discharge
Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor	3 months, 6 months, 12 months and 24 months post-ICU discharge
The Positive Affect Scale (PAS) - Family Caregivers	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Impact Scale (CIS) - Family Caregivers	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Assistance Scale (CAS) - Family Caregivers	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers	7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR); Ontario Ministry of Health and Long Term Care; Canadian Critical Care Trials Group
• Investigators: Principal Investigator: Margaret Herridge, MSc MD MPH, University Health Network, Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Anticipated): October 1, 2010
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: May 8, 2009
• First Submitted That Met QC Criteria: May 8, 2009
• First Posted (Estimate): May 11, 2009

Study Record Updates

• Last Update Posted (Estimate): October 9, 2009
• Last Update Submitted That Met QC Criteria: October 8, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: mechanical ventilation; quality of life; outcomes; weakness; chronic critical illness; Critically Ill patients and their family caregiver
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 06-0157-AE; IHP-94531