Improving Partnerships With Family Members of ICU Patients (IMPACT)
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Queensland
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Gold Coast, Queensland, Australia
- Reclutamento
- Gold Coast Health
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Contatto:
- Andrea Marshall
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-
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Alberta
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Calgary, Alberta, Canada
- Ritirato
- University of Calgary
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Ontario
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Ottawa, Ontario, Canada
- Reclutamento
- University of Ottawa
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Contatto:
- Kwadwo Kyeremanteng
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Toronto, Ontario, Canada
- Reclutamento
- Sunnybrook Health Science Centre
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Contatto:
- Dominique Piquette
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Toronto, Ontario, Canada
- Terminato
- University Health Network
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-
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Arizona
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Phoenix, Arizona, Stati Uniti, 85012
- Reclutamento
- Phoenix VA Medical Center
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Contatto:
- Mary Chew
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63110-1093
- Reclutamento
- Barnes Jewish Hospital/Washington University
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Contatto:
- Beth Taylor
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
- Reclutamento
- Penn State Milton S. Hershey Medical Center
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Contatto:
- Lauren Van Scoy
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Washington
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Vancouver, Washington, Stati Uniti, 98686
- Reclutamento
- Legacy Salmon Creek Medical Center
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Contatto:
- Joseph Jura, Dr
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Reclutamento
- Medical College of Wisconsin
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Contatto:
- Jayshil Patel
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
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Altri nomi:
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Sperimentale: Decision Support Program
Decision support education for family members of an elderly critically ill patient
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Altri nomi:
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Nessun intervento: Solita cura
Nessun intervento
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Nutritional adequacy during the ICU stay
Lasso di tempo: Up to 30 days in ICU
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Up to 30 days in ICU
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|
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Consumption of Oral Nutritional Supplements
Lasso di tempo: First four weeks once on ward
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First four weeks once on ward
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|
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Intake on hospital wards (3 day calorie count)
Lasso di tempo: First four weeks once on ward
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First four weeks once on ward
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|
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Hand grip strength
Lasso di tempo: 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)
Lasso di tempo: Within first week in ICU
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Within first week in ICU
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|
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Change in decisional conflict
Lasso di tempo: 1 week
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10-item Decisional Conflict Scale
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1 week
|
|
Family satisfaction with decision-making
Lasso di tempo: 1 week
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1 week
|
|
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Overall family satisfaction with ICU
Lasso di tempo: At ICU discharge, an average of 12 days
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At ICU discharge, an average of 12 days
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Daren Heyland, MD, Clinical Evaluation Research Unit
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IMPACT
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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