Improving Partnerships With Family Members of ICU Patients
- Conditions
- Critical Illness
- Interventions
- Behavioral: Nutrition Education ProgramOther: Decision Support Program
- Registration Number
- NCT02920086
- Lead Sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutrition Education Program Nutrition Education Program Nutrition education for family members of an elderly critically ill patient Decision Support Program Decision Support Program Decision support education for family members of an elderly critically ill patient
- Primary Outcome Measures
Name Time Method Consumption of Oral Nutritional Supplements First four weeks once on ward Use of shared-decision making (OPTION tool) Within first week in ICU Hand grip strength At or before hospital discharge or up to 90 days Hydraulic hand dynamometer
Intake on hospital wards (3 day calorie count) First four weeks once on ward Nutritional adequacy during the ICU stay Up to 30 days in ICU Change in decisional conflict 1 week 10-item Decisional Conflict Scale
Family satisfaction with decision-making 1 week Overall family satisfaction with ICU At ICU discharge, an average of 12 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Barnes Jewish Hospital/Washington University
🇺🇸Saint Louis, Missouri, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Gold Coast Health
🇦🇺Gold Coast, Queensland, Australia
Legacy Salmon Creek Medical Center
🇺🇸Vancouver, Washington, United States
University of Ottawa
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
Phoenix VA Medical Center
🇺🇸Phoenix, Arizona, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada