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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02920086




Registration number
NCT02920086
Ethics application status
Date submitted
19/09/2016
Date registered
30/09/2016

Titles & IDs
Public title
Improving Partnerships With Family Members of ICU Patients
Scientific title
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Secondary ID [1] 0 0
IMPACT
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Nutrition Education Program
Other interventions - Decision Support Program

Experimental: Nutrition Education Program - Nutrition education for family members of an elderly critically ill patient

Experimental: Decision Support Program - Decision support education for family members of an elderly critically ill patient

No intervention: Usual Care - No intervention


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 interventions: 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
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nutritional adequacy during the ICU stay
Timepoint [1] 0 0
Up to 30 days in ICU
Primary outcome [2] 0 0
Consumption of Oral Nutritional Supplements
Timepoint [2] 0 0
First four weeks once on ward
Primary outcome [3] 0 0
Intake on hospital wards (3 day calorie count)
Timepoint [3] 0 0
First four weeks once on ward
Primary outcome [4] 0 0
Hand grip strength
Timepoint [4] 0 0
At or before hospital discharge or up to 90 days
Primary outcome [5] 0 0
Use of shared-decision making (OPTION tool)
Timepoint [5] 0 0
Within first week in ICU
Primary outcome [6] 0 0
Change in decisional conflict
Timepoint [6] 0 0
1 week
Primary outcome [7] 0 0
Family satisfaction with decision-making
Timepoint [7] 0 0
1 week
Primary outcome [8] 0 0
Overall family satisfaction with ICU
Timepoint [8] 0 0
At ICU discharge, an average of 12 days

Eligibility
Key inclusion 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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast Health - Gold Coast
Recruitment postcode(s) [1] 0 0
- Gold Coast
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Clinical Evaluation Research Unit at Kingston General Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Griffith University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daren Heyland, MD
Address 0 0
Clinical Evaluation Research Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daren Heyland, MD
Address 0 0
Country 0 0
Phone 0 0
613-549-6666
Fax 0 0
Email 0 0
dkh2@queensu.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02920086