Clinical trial NCT02920086: Improving Partnerships With Family Members of ICU Patients
Official title: Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Lead sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Griffith University
First posted: 2016-09-30
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Nutritional adequacy during the ICU stay
timeFrame: Up to 30 days in ICU
measure: Consumption of Oral Nutritional Supplements
timeFrame: First four weeks once on ward
measure: Intake on hospital wards (3 day calorie count)
timeFrame: First four weeks once on ward
measure: Hand grip strength
timeFrame: At or before hospital discharge or up to 90 days
measure: Use of shared-decision making (OPTION tool)
timeFrame: Within first week in ICU
measure: Change in decisional conflict
timeFrame: 1 week
measure: Family satisfaction with decision-making
timeFrame: 1 week
measure: Overall family satisfaction with ICU
timeFrame: At ICU discharge, an average of 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Medical Center
state: Arizona
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital/Washington University
state: Missouri
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Vancouver
country: United States
facility: Legacy Salmon Creek Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Gold Coast
country: Australia
facility: Gold Coast Health
state: Queensland
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Clinical Evaluation Research Unit
name: Daren Heyland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heyland DK, Davidson J, Skrobik Y, des Ordons AR, Van Scoy LJ, Day AG, Vandall-Walker V, Marshall AP. Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):3. doi: 10.1186/s13063-017-2379-4.