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Improving Partnerships With Family Members of ICU Patients (IMPACT)

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nutrition Education Program
Decision Support Program
Sponsored by
Clinical Evaluation Research Unit at Kingston General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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ICU for 72 hours after initial screening (physician judgment) or for whom life-sustaining treatments are expected to be withdrawn in the subsequent 72 hours (as sufficient time will be required for implementation of the study interventions)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).

Sites / Locations

  • Phoenix VA Medical CenterRecruiting
  • Barnes Jewish Hospital/Washington UniversityRecruiting
  • Penn State Milton S. Hershey Medical CenterRecruiting
  • Legacy Salmon Creek Medical CenterRecruiting
  • Medical College of WisconsinRecruiting
  • Gold Coast HealthRecruiting
  • University of Calgary
  • University of OttawaRecruiting
  • Sunnybrook Health Science CentreRecruiting
  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Nutrition Education Program

Decision Support Program

Usual Care

Arm Description

Nutrition education for family members of an elderly critically ill patient

Decision support education for family members of an elderly critically ill patient

No intervention

Outcomes

Primary Outcome Measures

Nutritional adequacy during the ICU stay
Consumption of Oral Nutritional Supplements
Intake on hospital wards (3 day calorie count)
Hand grip strength
Hydraulic hand dynamometer
Use of shared-decision making (OPTION tool)
Change in decisional conflict
10-item Decisional Conflict Scale
Family satisfaction with decision-making
Overall family satisfaction with ICU

Secondary Outcome Measures

Full Information

First Posted
September 19, 2016
Last Updated
September 5, 2019
Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), Griffith University
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1. Study Identification

Unique Protocol Identification Number
NCT02920086
Brief Title
Improving Partnerships With Family Members of ICU Patients
Acronym
IMPACT
Official Title
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), Griffith University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Education Program
Arm Type
Experimental
Arm Description
Nutrition education for family members of an elderly critically ill patient
Arm Title
Decision Support Program
Arm Type
Experimental
Arm Description
Decision support education for family members of an elderly critically ill patient
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education Program
Other Intervention Name(s)
OPTICS
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Decision Support Program
Other Intervention Name(s)
The REALISTIC-80 Decision Support Intervention, My ICU Guide
Intervention Description
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
Primary Outcome Measure Information:
Title
Nutritional adequacy during the ICU stay
Time Frame
Up to 30 days in ICU
Title
Consumption of Oral Nutritional Supplements
Time Frame
First four weeks once on ward
Title
Intake on hospital wards (3 day calorie count)
Time Frame
First four weeks once on ward
Title
Hand grip strength
Description
Hydraulic hand dynamometer
Time Frame
At or before hospital discharge or up to 90 days
Title
Use of shared-decision making (OPTION tool)
Time Frame
Within first week in ICU
Title
Change in decisional conflict
Description
10-item Decisional Conflict Scale
Time Frame
1 week
Title
Family satisfaction with decision-making
Time Frame
1 week
Title
Overall family satisfaction with ICU
Time Frame
At ICU discharge, an average of 12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daren Heyland, MD
Phone
613-549-6666
Ext
3339
Email
dkh2@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daren Heyland, MD
Organizational Affiliation
Clinical Evaluation Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Chew
Facility Name
Barnes Jewish Hospital/Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Taylor
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Van Scoy
Facility Name
Legacy Salmon Creek Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Jura, Dr
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayshil Patel
Facility Name
Gold Coast Health
City
Gold Coast
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Marshall
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Withdrawn
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwadwo Kyeremanteng
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Piquette
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Terminated

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29301555
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.
Results Reference
derived

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Improving Partnerships With Family Members of ICU Patients

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