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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Griffith University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition Education Program | Experimental | Nutrition education for family members of an elderly critically ill patient |
|
| Decision Support Program | Experimental | Decision support education for family members of an elderly critically ill patient |
|
| Usual Care | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition Education Program | Behavioral |
|
| 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 |
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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:
Exclusion Criteria for Patients:
Inclusion Criteria for Family Member:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daren Heyland, MD | Contact | 613-549-6666 | 3339 | dkh2@queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| Daren Heyland, MD | Clinical Evaluation Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Medical Center | Recruiting | Phoenix | Arizona | 85012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37161555 | Derived | 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. | |
| 29301555 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055095 | Optics and Photonics |
| ID | Term |
|---|---|
| D004738 | Engineering |
| D013676 | Technology, Industry, and Agriculture |
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| Decision Support Program | Other |
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| Barnes Jewish Hospital/Washington University | Recruiting | St Louis | Missouri | 63110-1093 | United States |
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| Penn State Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Legacy Salmon Creek Medical Center | Recruiting | Vancouver | Washington | 98686 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Gold Coast Health | Recruiting | Gold Coast | Queensland | Australia |
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| University of Calgary | Withdrawn | Calgary | Alberta | Canada |
| University of Ottawa | Recruiting | Ottawa | Ontario | Canada |
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| Sunnybrook Health Science Centre | Recruiting | Toronto | Ontario | Canada |
|
| University Health Network | Terminated | Toronto | Ontario | Canada |
| Derived |
| 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. |