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Improving Partnerships With Family Members of ICU Patients (IMPACT)

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ClinicalTrials.gov Identifier: NCT02920086
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Griffith University
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Critical Illness Behavioral: Nutrition Education Program Other: Decision Support Program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Nutritional adequacy during the ICU stay [ Time Frame: Up to 30 days in ICU ]
  2. Consumption of Oral Nutritional Supplements [ Time Frame: First four weeks once on ward ]
  3. Intake on hospital wards (3 day calorie count) [ Time Frame: First four weeks once on ward ]
  4. Hand grip strength [ Time Frame: At or before hospital discharge or up to 90 days ]
    Hydraulic hand dynamometer

  5. Use of shared-decision making (OPTION tool) [ Time Frame: Within first week in ICU ]
  6. Change in decisional conflict [ Time Frame: 1 week ]
    10-item Decisional Conflict Scale

  7. Family satisfaction with decision-making [ Time Frame: 1 week ]
  8. Overall family satisfaction with ICU [ Time Frame: At ICU discharge, an average of 12 days ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920086


Contacts
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Contact: Daren Heyland, MD 613-549-6666 ext 3339 dkh2@queensu.ca

Locations
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United States, Arizona
Phoenix VA Medical Center Recruiting
Phoenix, Arizona, United States, 85012
Contact: Mary Chew         
United States, Missouri
Barnes Jewish Hospital/Washington University Recruiting
Saint Louis, Missouri, United States, 63110-1093
Contact: Beth Taylor         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lauren Van Scoy         
United States, Washington
Legacy Salmon Creek Medical Center Recruiting
Vancouver, Washington, United States, 98686
Contact: Joseph Jura, Dr         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jayshil Patel         
Australia, Queensland
Gold Coast Health Recruiting
Gold Coast, Queensland, Australia
Contact: Andrea Marshall         
Canada, Alberta
University of Calgary Withdrawn
Calgary, Alberta, Canada
Canada, Ontario
University of Ottawa Recruiting
Ottawa, Ontario, Canada
Contact: Kwadwo Kyeremanteng         
Sunnybrook Health Science Centre Recruiting
Toronto, Ontario, Canada
Contact: Dominique Piquette         
University Health Network Terminated
Toronto, Ontario, Canada
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
Canadian Institutes of Health Research (CIHR)
Griffith University
Investigators
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Principal Investigator: Daren Heyland, MD Clinical Evaluation Research Unit
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daren K. Heyland, Principal Investigator, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT02920086    
Other Study ID Numbers: IMPACT
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes