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:
- 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
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5B 1W8
- 募集
- St. Michael's Hospital
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コンタクト:
- Jan Friedrich, MD
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主任研究者:
- Jan Friedrich, PhD MD FRCPC
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Toronto、Ontario、カナダ、M5G 1X5
- 募集
- Mount Sinai Hospital
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コンタクト:
- Sangeeta Mehta, MD
- メール:geeta.mehta@utoronto.ca
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主任研究者:
- Sangeeta Mehta, MD FRCPC
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Toronto、Ontario、カナダ、M4N 3M5
- 募集
- Sunnybrook
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コンタクト:
- Neill Adhikari, MD
- メール:neil.adhikari@sunnybrook.ca
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主任研究者:
- Neill Adhikari, MD FRCPC MSc
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Toronto、Ontario、カナダ、M5G 2C4
- 募集
- Toronto Western Hospital
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コンタクト:
- Andrea Matte, RRT
- 電話番号:416-603-5967
- メール:andrea.matte@uhn.on.ca
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主任研究者:
- Niall Ferguson, MD FRCPC MSc
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Toronto、Ontario、カナダ、M5G 2N2
- 募集
- Toronto General Hospital
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コンタクト:
- Andrea Matte, RRT
- 電話番号:416-603-5967
- メール:andrea.matte@uhn.on.ca
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主任研究者:
- Margaret S. Herridge, MSc MD FRCPC MPH
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
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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
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Functional Independence Measure (FIM) - ICU Survivor
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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Six Minute Walking Test (6MWT) - ICU Survivor
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor
時間枠:3 months, 6 months, 12 months and 24 months post-ICU discharge
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3 months, 6 months, 12 months and 24 months post-ICU discharge
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Beck Depression Inventory-II (BDI-II) - ICU Survivor
時間枠:3 months, 6 months, 12 months and 24 months post-ICU discharge
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3 months, 6 months, 12 months and 24 months post-ICU discharge
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Impact of Event Scale (IES) - ICU Survivor
時間枠:3 months, 6 months, 12 months and 24 months post-ICU discharge
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3 months, 6 months, 12 months and 24 months post-ICU discharge
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Hospital mortality - ICU Survivor
時間枠:1 and 2 years post-ICU discharge
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1 and 2 years post-ICU discharge
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Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor
時間枠:3 months, 6 months, 12 months and 24 months post-ICU discharge
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3 months, 6 months, 12 months and 24 months post-ICU discharge
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The Positive Affect Scale (PAS) - Family Caregivers
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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The Care-giving Impact Scale (CIS) - Family Caregivers
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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The Care-giving Assistance Scale (CAS) - Family Caregivers
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers
時間枠:7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
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協力者と研究者
協力者
捜査官
- 主任研究者:Margaret Herridge, MSc MD MPH、University Health Network, Toronto
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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