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

Critically Ill Clinical Trial

— RECOVER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00896220
• Other study ID #: 06-0157-AE
• Secondary ID: IHP-94531
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2009
• Last updated: October 8, 2009
• Start date: April 2006
• Est. completion date: October 2012

Study information

• Verified date: May 2009
• Source: University Health Network, Toronto
• Contact: Andrea Matte, RRT
• Phone: 416-340-3057
• Email: andrea.matte[@]uhn.on.ca
• Is FDA regulated: No
• Health authority: Canada: UHN Research Ethics Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matté 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. Epub 2006 Jun 8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Independence Measure (FIM) - ICU Survivor		7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Primary	Six Minute Walking Test (6MWT) - ICU Survivor		7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor		3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	Beck Depression Inventory-II (BDI-II) - ICU Survivor		3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	Impact of Event Scale (IES) - ICU Survivor		3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	Hospital mortality - ICU Survivor		1 and 2 years post-ICU discharge	No
Secondary	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	No
Secondary	The Positive Affect Scale (PAS) - Family Caregivers		7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers		7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	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	No
Secondary	The Care-giving Impact Scale (CIS) - Family Caregivers		7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	The Care-giving Assistance Scale (CAS) - Family Caregivers		7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge	No
Secondary	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	No