Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Enrollment
- 150
- Locations
- 10
- Primary Endpoint
- Consumption of Oral Nutritional Supplements
- Last Updated
- 6 years ago
Overview
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.
Investigators
Daren K. Heyland
Principal Investigator
Clinical Evaluation Research Unit at Kingston General Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Consumption of Oral Nutritional Supplements
Time Frame: First four weeks once on ward
Use of shared-decision making (OPTION tool)
Time Frame: Within first week in ICU
Hand grip strength
Time Frame: At or before hospital discharge or up to 90 days
Hydraulic hand dynamometer
Intake on hospital wards (3 day calorie count)
Time Frame: First four weeks once on ward
Nutritional adequacy during the ICU stay
Time Frame: Up to 30 days in ICU
Change in decisional conflict
Time Frame: 1 week
10-item Decisional Conflict Scale
Family satisfaction with decision-making
Time Frame: 1 week
Overall family satisfaction with ICU
Time Frame: At ICU discharge, an average of 12 days