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Clinical Trials/NCT02920086
NCT02920086
Unknown
Not Applicable

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

Clinical Evaluation Research Unit at Kingston General Hospital10 sites in 3 countries150 target enrollmentMay 9, 2017

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2017
End Date
December 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (10)

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