Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 15
- 主要终点
- Consumption of Oral Nutritional Supplements
研究概览
简要总结
The purpose of this study is to improve the outcomes of critically ill older patients and the health outcomes of their families by capacitating and partnering with families in optimizing patient/family centered care.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Usual Care
No intervention
Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
干预措施: Nutrition Education Program (Behavioral)
Decision Support Program
Decision support education for family members of an elderly critically ill patient
干预措施: Decision Support Program (Other)
结局指标
主要结局
Consumption of Oral Nutritional Supplements
时间窗: First four weeks once on ward
Use of shared-decision making (OPTION tool)
时间窗: Within first week in ICU
Hand grip strength
时间窗: At or before hospital discharge or up to 90 days
Hydraulic hand dynamometer
Intake on hospital wards (3 day calorie count)
时间窗: First four weeks once on ward
Nutritional adequacy during the ICU stay
时间窗: Up to 30 days in ICU
Change in decisional conflict
时间窗: 1 week
10-item Decisional Conflict Scale
Family satisfaction with decision-making
时间窗: 1 week
Overall family satisfaction with ICU
时间窗: At ICU discharge, an average of 12 days
次要结局
未报告次要终点
研究者
Daren K. Heyland
Principal Investigator
Clinical Evaluation Research Unit at Kingston General Hospital