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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Critically Ill

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Critical Care Trials Group

OTHER

Sponsor Role collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

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

Site Status RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Andrea Matte, RRT

Role: CONTACT

416-340-3057

Facility Contacts

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Neill Adhikari, MD

Role: primary

Jan Friedrich, MD

Role: primary

Sangeeta Mehta, MD

Role: primary

Andrea Matte, RRT

Role: primary

416-603-5967

Andrea Matte, RRT

Role: primary

416-603-5967

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.

Reference Type BACKGROUND
PMID: 12594312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16374160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16763220 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27168433 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25466314 (View on PubMed)

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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