Improving Partnerships With Family Members of ICU Patients (IMPACT)
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Queensland
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Gold Coast, Queensland, Australien
- Rekrutierung
- Gold Coast Health
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Kontakt:
- Andrea Marshall
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-
-
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Alberta
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Calgary, Alberta, Kanada
- Zurückgezogen
- University Of Calgary
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Ontario
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Ottawa, Ontario, Kanada
- Rekrutierung
- University of Ottawa
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Kontakt:
- Kwadwo Kyeremanteng
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Toronto, Ontario, Kanada
- Rekrutierung
- Sunnybrook Health Science Centre
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Kontakt:
- Dominique Piquette
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Toronto, Ontario, Kanada
- Beendet
- University Health Network
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-
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85012
- Rekrutierung
- Phoenix VA Medical Center
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Kontakt:
- Mary Chew
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Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63110-1093
- Rekrutierung
- Barnes Jewish Hospital/Washington University
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Kontakt:
- Beth Taylor
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Pennsylvania
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Hershey, Pennsylvania, Vereinigte Staaten, 17033
- Rekrutierung
- Penn State Milton S. Hershey Medical Center
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Kontakt:
- Lauren Van Scoy
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Washington
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Vancouver, Washington, Vereinigte Staaten, 98686
- Rekrutierung
- Legacy Salmon Creek Medical Center
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Kontakt:
- Joseph Jura, Dr
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Rekrutierung
- Medical College of Wisconsin
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Kontakt:
- Jayshil Patel
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
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Andere Namen:
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Experimental: Decision Support Program
Decision support education for family members of an elderly critically ill patient
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Andere Namen:
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Kein Eingriff: Übliche Pflege
Kein Eingriff
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Nutritional adequacy during the ICU stay
Zeitfenster: Up to 30 days in ICU
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Up to 30 days in ICU
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Consumption of Oral Nutritional Supplements
Zeitfenster: First four weeks once on ward
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First four weeks once on ward
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Intake on hospital wards (3 day calorie count)
Zeitfenster: First four weeks once on ward
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First four weeks once on ward
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Hand grip strength
Zeitfenster: At or before hospital discharge or up to 90 days
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Hydraulic hand dynamometer
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At or before hospital discharge or up to 90 days
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Use of shared-decision making (OPTION tool)
Zeitfenster: Within first week in ICU
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Within first week in ICU
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Change in decisional conflict
Zeitfenster: 1 week
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10-item Decisional Conflict Scale
|
1 week
|
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Family satisfaction with decision-making
Zeitfenster: 1 week
|
1 week
|
|
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Overall family satisfaction with ICU
Zeitfenster: At ICU discharge, an average of 12 days
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At ICU discharge, an average of 12 days
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Daren Heyland, MD, Clinical Evaluation Research Unit
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IMPACT
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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