Improving Partnerships With Family Members of ICU Patients
NCT ID: NCT02920086
Last Updated: 2019-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2017-05-09
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
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)
Decision Support Program
Decision support education for family members of an elderly critically ill patient
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
Usual Care
No intervention
No interventions assigned to this group
Interventions
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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)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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).
Exclusion Criteria
* Uncomplicated elective surgical patients (regardless of age)
* Patients who have received organ transplantation during this hospitalization
55 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Griffith University
OTHER
Clinical Evaluation Research Unit at Kingston General Hospital
OTHER
Responsible Party
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Daren K. Heyland
Principal Investigator
Principal Investigators
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Daren Heyland, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Evaluation Research Unit
Locations
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Phoenix VA Medical Center
Phoenix, Arizona, United States
Barnes Jewish Hospital/Washington University
St Louis, Missouri, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Gold Coast Health
Gold Coast, Queensland, Australia
University of Calgary
Calgary, Alberta, Canada
University of Ottawa
Ottawa, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Mary Chew
Role: primary
Beth Taylor
Role: primary
Lauren Van Scoy
Role: primary
Joseph Jura, Dr
Role: primary
Jayshil Patel
Role: primary
Andrea Marshall
Role: primary
Kwadwo Kyeremanteng
Role: primary
Dominique Piquette
Role: primary
References
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Marshall AP, Van Scoy LJ, Chaboyer W, Chew M, Davidson J, Day AG, Martinez A, Patel J, Roberts S, Skrobik Y, Taylor B, Tobiano G, Heyland DK. A randomised controlled trial of a nutrition and a decision support intervention to enable partnerships with families of critically ill patients. J Clin Nurs. 2023 Sep;32(17-18):6723-6742. doi: 10.1111/jocn.16752. Epub 2023 May 9.
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.
Other Identifiers
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IMPACT
Identifier Type: -
Identifier Source: org_study_id
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