- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02920086
Improving Partnerships With Family Members of ICU Patients (IMPACT)
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Queensland
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Gold Coast, Queensland, Australia
- Reclutamiento
- Gold Coast Health
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Contacto:
- Andrea Marshall
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-
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Alberta
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Calgary, Alberta, Canadá
- Retirado
- University of Calgary
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Ontario
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Ottawa, Ontario, Canadá
- Reclutamiento
- University of Ottawa
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Contacto:
- Kwadwo Kyeremanteng
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Toronto, Ontario, Canadá
- Reclutamiento
- Sunnybrook Health Science Centre
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Contacto:
- Dominique Piquette
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Toronto, Ontario, Canadá
- Terminado
- University Health Network
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-
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Arizona
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Phoenix, Arizona, Estados Unidos, 85012
- Reclutamiento
- Phoenix VA Medical Center
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Contacto:
- Mary Chew
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110-1093
- Reclutamiento
- Barnes Jewish Hospital/Washington University
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Contacto:
- Beth Taylor
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Reclutamiento
- Penn State Milton S. Hershey Medical Center
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Contacto:
- Lauren Van Scoy
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Washington
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Vancouver, Washington, Estados Unidos, 98686
- Reclutamiento
- Legacy Salmon Creek Medical Center
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Contacto:
- Joseph Jura, Dr
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Reclutamiento
- Medical College of Wisconsin
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Contacto:
- Jayshil Patel
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
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Otros nombres:
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Experimental: Decision Support Program
Decision support education for family members of an elderly critically ill patient
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Otros nombres:
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Sin intervención: Cuidado usual
Sin intervención
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Nutritional adequacy during the ICU stay
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: First four weeks once on ward
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First four weeks once on ward
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Hand grip strength
Periodo de tiempo: 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)
Periodo de tiempo: Within first week in ICU
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Within first week in ICU
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Change in decisional conflict
Periodo de tiempo: 1 week
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10-item Decisional Conflict Scale
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1 week
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Family satisfaction with decision-making
Periodo de tiempo: 1 week
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1 week
|
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Overall family satisfaction with ICU
Periodo de tiempo: At ICU discharge, an average of 12 days
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At ICU discharge, an average of 12 days
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Daren Heyland, MD, Clinical Evaluation Research Unit
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IMPACT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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-
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-
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-
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-
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