Improving Partnerships With Family Members of ICU Patients (IMPACT)
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
調査の概要
詳細な説明
There is a pressing need to improve the care of critically ill older patients. For critically ill patients who are frequently unable to participate in their own care and decision-making, partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. However, the optimal means by which families engage in the role they play, and how best to capacitate them as advocates and partners in care while helping them maintain their own wellbeing, is not known.
The IMPACT trial will evaluate two interventions, each with a separate context, but similar in that they empower and support families; one focused on involvement in care, and the other focused on involvement in decision-making. The first is a nutrition intervention The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICs) intervention, a multi-faceted strategy to engage and empower family members to advocate for and audit best nutrition practices in their family members. The second is a decision support intervention. The REALISTIC-80 Decision Support Intervention, is a web-based tool (www.myicuguide.com) to support families in shared decision-making about goals of medical treatments.
The investigators propose to conduct a mixed methods multi-centre, open-label, randomized, clinical trial involving 3 groups (2 active interventions and a usual care group). The overall goal of this study is to demonstrate that the multi-faceted nutritional strategies that engage families in care of their family member tested in this trial will increase nutritional intake and optimize physical recovery in older critically ill patients at high nutrition risk.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Daren Heyland, MD
- 電話番号:3339 613-549-6666
- メール:dkh2@queensu.ca
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85012
- 募集
- Phoenix VA Medical Center
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コンタクト:
- Mary Chew
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Missouri
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Saint Louis、Missouri、アメリカ、63110-1093
- 募集
- Barnes Jewish Hospital/Washington University
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コンタクト:
- Beth Taylor
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- 募集
- Penn State Milton S. Hershey Medical Center
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コンタクト:
- Lauren Van Scoy
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Washington
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Vancouver、Washington、アメリカ、98686
- 募集
- Legacy Salmon Creek Medical Center
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コンタクト:
- Joseph Jura, Dr
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- 募集
- Medical College of Wisconsin
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コンタクト:
- Jayshil Patel
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Queensland
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Gold Coast、Queensland、オーストラリア
- 募集
- Gold Coast Health
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コンタクト:
- Andrea Marshall
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Alberta
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Calgary、Alberta、カナダ
- 引きこもった
- University of Calgary
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Ontario
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Ottawa、Ontario、カナダ
- 募集
- University of Ottawa
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コンタクト:
- Kwadwo Kyeremanteng
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Toronto、Ontario、カナダ
- 募集
- Sunnybrook Health Science Centre
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コンタクト:
- Dominique Piquette
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Toronto、Ontario、カナダ
- 終了しました
- University Health Network
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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
説明
Inclusion Criteria for Patients:
1a) > 60 years of age OR
1b) 55 years to 59 years old with one or more of the following diagnoses:
- Chronic obstructive lung disease - 2 of the 4 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L.
- Congestive heart failure - New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%.
- Cirrhosis - confirmed by imaging studies or documentation of esophageal varices and one of three conditions: a) hepatic coma, b) Child's class C liver disease, or c) Child's class B liver disease with gastrointestinal bleeding.
- Cancer - metastatic cancer or stage IV lymphoma.
- End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness) 2) Have a projected duration of ICU dependency of >72 hours from time of final assessment. We define ICU dependency as the need for one or more of the following:
- Mechanical ventilation
- Non-invasive ventilation
- Renal replacement therapy
- Vasopressors or
- Artificial nutrition because of their underlying illness
Exclusion Criteria for Patients:
- Patients who are not expected to remain alive in ICU for 72 hours after initial screening (physician judgment) or for whom life-sustaining treatments are expected to be withdrawn in the subsequent 72 hours (as sufficient time will be required for implementation of the study interventions)
- Uncomplicated elective surgical patients (regardless of age)
- Patients who have received organ transplantation during this hospitalization
Inclusion Criteria for Family Member:
- 18 years of age or older,
- present and expected to visit regularly (minimum about 3 times a week) while the patient is in hospital
- the nominated or legally appointed substitute decision-maker
- able to communicate in English (verbally and in writing).
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
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
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他の名前:
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実験的:Decision Support Program
Decision support education for family members of an elderly critically ill patient
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他の名前:
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介入なし:いつものお手入れ
介入なし
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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 |
メジャーの説明 |
時間枠 |
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Nutritional adequacy during the ICU stay
時間枠:Up to 30 days in ICU
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Up to 30 days in ICU
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Consumption of Oral Nutritional Supplements
時間枠:First four weeks once on ward
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First four weeks once on ward
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Intake on hospital wards (3 day calorie count)
時間枠:First four weeks once on ward
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First four weeks once on ward
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Hand grip strength
時間枠:At or before hospital discharge or up to 90 days
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Hydraulic hand dynamometer
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At or before hospital discharge or up to 90 days
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Use of shared-decision making (OPTION tool)
時間枠:Within first week in ICU
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Within first week in ICU
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Change in decisional conflict
時間枠:1 week
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10-item Decisional Conflict Scale
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1 week
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Family satisfaction with decision-making
時間枠:1 week
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1 week
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Overall family satisfaction with ICU
時間枠:At ICU discharge, an average of 12 days
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At ICU discharge, an average of 12 days
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協力者と研究者
捜査官
- 主任研究者:Daren Heyland, MD、Clinical Evaluation Research Unit
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Nutrition Education Programの臨床試験
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne積極的、募集していない
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Children's Health積極的、募集していない
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Brown UniversityHarvard University; West Virginia University; Canandaigua VA Medical Center; The Warren Alpert Foundation募集