Improving Partnerships With Family Members of ICU Patients (IMPACT)
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| ClinicalTrials.gov Identifier: NCT02920086 |
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Recruitment Status :
Recruiting
First Posted : September 30, 2016
Last Update Posted : September 28, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Illness | Behavioral: Nutrition Education Program Other: Decision Support Program | Not Applicable |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
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Behavioral: Nutrition Education Program
Other Name: OPTICS |
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Experimental: Decision Support Program
Decision support education for family members of an elderly critically ill patient
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Other: Decision Support Program
Other Names:
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No Intervention: Usual Care
No intervention
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- Nutritional adequacy during the ICU stay [ Time Frame: Up to 30 days in ICU ]
- Consumption of Oral Nutritional Supplements [ Time Frame: First four weeks once on ward ]
- Intake on hospital wards (3 day calorie count) [ Time Frame: First four weeks once on ward ]
- Hand grip strength [ Time Frame: At or before hospital discharge or up to 90 days ]Hydraulic hand dynamometer
- Use of shared-decision making (OPTION tool) [ Time Frame: Within first week in ICU ]
- Change in decisional conflict [ Time Frame: 1 week ]10-item Decisional Conflict Scale
- Family satisfaction with decision-making [ Time Frame: 1 week ]
- Overall family satisfaction with ICU [ Time Frame: At ICU discharge, an average of 12 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
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
| Contact: Daren Heyland, MD | 613-549-6666 ext 3339 | dkh2@queensu.ca |
| 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, 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 | |
| Logan Hospital, Metro South Health | Not yet recruiting |
| Logan, Queensland, Australia, 4131 | |
| Contact: Kellie Sosnowski | |
| 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: Taz Sinuff | |
| University Health Network | Terminated |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Daren Heyland, MD | Clinical Evaluation Research Unit |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daren K. Heyland, Principal Investigator, Clinical Evaluation Research Unit at Kingston General Hospital |
| ClinicalTrials.gov Identifier: | NCT02920086 History of Changes |
| Other Study ID Numbers: |
IMPACT |
| First Posted: | September 30, 2016 Key Record Dates |
| Last Update Posted: | September 28, 2018 |
| Last Verified: | September 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |