Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers (RECOVER)
8 octobre 2009 mis à jour par: University Health Network, Toronto
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:
- There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation.
- 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).
- 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
Aperçu de l'étude
Statut
Inconnue
Les conditions
Type d'étude
Observationnel
Inscription (Anticipé)
500
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Andrea Matte, RRT
- Numéro de téléphone: 416-340-3057
- E-mail: andrea.matte@uhn.on.ca
Lieux d'étude
-
-
Ontario
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Toronto, Ontario, Canada, M5B 1W8
- Recrutement
- St. Michael's Hospital
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Contact:
- Jan Friedrich, MD
-
Chercheur principal:
- Jan Friedrich, PhD MD FRCPC
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Toronto, Ontario, Canada, M5G 1X5
- Recrutement
- Mount Sinai Hospital
-
Contact:
- Sangeeta Mehta, MD
- E-mail: geeta.mehta@utoronto.ca
-
Chercheur principal:
- Sangeeta Mehta, MD FRCPC
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Toronto, Ontario, Canada, M4N 3M5
- Recrutement
- Sunnybrook
-
Contact:
- Neill Adhikari, MD
- E-mail: neil.adhikari@sunnybrook.ca
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Chercheur principal:
- Neill Adhikari, MD FRCPC MSc
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Toronto, Ontario, Canada, M5G 2C4
- Recrutement
- Toronto Western Hospital
-
Contact:
- Andrea Matte, RRT
- Numéro de téléphone: 416-603-5967
- E-mail: andrea.matte@uhn.on.ca
-
Chercheur principal:
- Niall Ferguson, MD FRCPC MSc
-
Toronto, Ontario, Canada, M5G 2N2
- Recrutement
- Toronto General Hospital
-
Contact:
- Andrea Matte, RRT
- Numéro de téléphone: 416-603-5967
- E-mail: andrea.matte@uhn.on.ca
-
Chercheur principal:
- Margaret S. Herridge, MSc MD FRCPC MPH
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
16 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Critically ill individuals who require mechanical ventilation for one week or greater and their primary family caregiver
La 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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Functional Independence Measure (FIM) - ICU Survivor
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
Six Minute Walking Test (6MWT) - ICU Survivor
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor
Délai: 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
Beck Depression Inventory-II (BDI-II) - ICU Survivor
Délai: 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
Impact of Event Scale (IES) - ICU Survivor
Délai: 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
Hospital mortality - ICU Survivor
Délai: 1 and 2 years post-ICU discharge
|
1 and 2 years post-ICU discharge
|
|
Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor
Délai: 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
The Positive Affect Scale (PAS) - Family Caregivers
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
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
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
The Care-giving Impact Scale (CIS) - Family Caregivers
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
|
The Care-giving Assistance Scale (CAS) - Family Caregivers
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
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
Délai: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Margaret Herridge, MSc MD MPH, University Health Network, Toronto
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2006
Achèvement primaire (Anticipé)
1 octobre 2010
Achèvement de l'étude (Anticipé)
1 octobre 2012
Dates d'inscription aux études
Première soumission
8 mai 2009
Première soumission répondant aux critères de contrôle qualité
8 mai 2009
Première publication (Estimation)
11 mai 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
9 octobre 2009
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 octobre 2009
Dernière vérification
1 mai 2009
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 06-0157-AE
- IHP-94531
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .