Improving Partnerships With Family Members of ICU Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial

Conditions
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Critical Illness

Intervention / Treatment
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* Behavioral: Nutrition Education Program
* Other: Decision Support Program


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Education Program<br>Nutrition education for family members of an elderly critically ill patient | Behavioral: Nutrition Education Program<br>* The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention Nutritional education will be provided to ICU patents' families by a dietitian Tracking of nutritional information by family Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day)<br>* Other names: OPTICS;|
| Experimental: Decision Support Program<br>Decision support education for family members of an elderly critically ill patient | Other: Decision Support Program<br>* Families will be provided with a web-based decision support tool (My ICU Guide) Families will meet with the ICU medical team early in ICU stay to review goals of care<br>* Other names: My ICU Guide;|
| No Intervention: Usual Care<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional adequacy during the ICU stay |  | Up to 30 days in ICU | 
| Consumption of Oral Nutritional Supplements |  | First four weeks once on ward | 
| Intake on hospital wards (3 day calorie count) |  | First four weeks once on ward | 
| Hand grip strength | Hydraulic hand dynamometer | At or before hospital discharge or up to 90 days | 
| Use of shared-decision making (OPTION tool) |  | Within first week in ICU | 
| Change in decisional conflict | 10-item Decisional Conflict Scale | 1 week | 
| Family satisfaction with decision-making |  | 1 week | 
| Overall family satisfaction with ICU |  | At ICU discharge, an average of 12 days |