Improving Partnerships With Family Members of ICU Patients

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.

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).