Improving Partnerships With Family Members of ICU Patients (IMPACT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Behavioral: Nutrition Education Program; Other: Decision Support Program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Gold Coast, Queensland, Australia
      • Recruiting
      • Gold Coast Health
      • Contact: Andrea Marshall
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Withdrawn
      • University of Calgary
  • Ontario
    • Ottawa, Ontario, Canada
      • Recruiting
      • University of Ottawa
      • Contact: Kwadwo Kyeremanteng
    • Toronto, Ontario, Canada
      • Recruiting
      • Sunnybrook Health Science Centre
      • Contact: Dominique Piquette
    • Toronto, Ontario, Canada
      • Terminated
      • University Health Network
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Recruiting
      • Phoenix VA Medical Center
      • Contact: Mary Chew
  • Missouri
    • Saint Louis, Missouri, United States, 63110-1093
      • Recruiting
      • Barnes Jewish Hospital/Washington University
      • Contact: Beth Taylor
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Milton S. Hershey Medical Center
      • Contact: Lauren Van Scoy
  • Washington
    • Vancouver, Washington, United States, 98686
      • Recruiting
      • Legacy Salmon Creek Medical Center
      • Contact: Joseph Jura, Dr
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Jayshil Patel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition Education Program; Nutrition education for family members of an elderly critically ill patient	Behavioral: Nutrition Education Program; The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention; Nutritional education will be provided to ICU patents' families by a dietitian; Tracking of nutritional information by family; Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day); Other Names: OPTICS
Experimental: Decision Support Program; Decision support education for family members of an elderly critically ill patient	Other: Decision Support Program; Families will be provided with a web-based decision support tool (My ICU Guide); Families will meet with the ICU medical team early in ICU stay to review goals of care; Other Names: The REALISTIC-80 Decision Support Intervention; My ICU Guide
No Intervention: Usual Care; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional adequacy during the ICU stay		Up to 30 days in ICU
Consumption of Oral Nutritional Supplements		First four weeks once on ward
Intake on hospital wards (3 day calorie count)		First four weeks once on ward
Hand grip strength	Hydraulic hand dynamometer	At or before hospital discharge or up to 90 days
Use of shared-decision making (OPTION tool)		Within first week in ICU
Change in decisional conflict	10-item Decisional Conflict Scale	1 week
Family satisfaction with decision-making		1 week
Overall family satisfaction with ICU		At ICU discharge, an average of 12 days

Collaborators and Investigators

• Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
• Collaborators: Canadian Institutes of Health Research (CIHR); Griffith University
• Investigators: Principal Investigator: Daren Heyland, MD, Clinical Evaluation Research Unit

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: IMPACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No