Improving Partnerships With Family Members of ICU Patients (IMPACT)
Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Queensland
-
Gold Coast, Queensland, Austrália
- Recrutamento
- Gold Coast Health
-
Contato:
- Andrea Marshall
-
-
-
-
Alberta
-
Calgary, Alberta, Canadá
- Retirado
- University Of Calgary
-
-
Ontario
-
Ottawa, Ontario, Canadá
- Recrutamento
- University of Ottawa
-
Contato:
- Kwadwo Kyeremanteng
-
Toronto, Ontario, Canadá
- Recrutamento
- Sunnybrook Health Science Centre
-
Contato:
- Dominique Piquette
-
Toronto, Ontario, Canadá
- Rescindido
- University Health Network
-
-
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85012
- Recrutamento
- Phoenix VA Medical Center
-
Contato:
- Mary Chew
-
-
Missouri
-
Saint Louis, Missouri, Estados Unidos, 63110-1093
- Recrutamento
- Barnes Jewish Hospital/Washington University
-
Contato:
- Beth Taylor
-
-
Pennsylvania
-
Hershey, Pennsylvania, Estados Unidos, 17033
- Recrutamento
- Penn State Milton S. Hershey Medical Center
-
Contato:
- Lauren Van Scoy
-
-
Washington
-
Vancouver, Washington, Estados Unidos, 98686
- Recrutamento
- Legacy Salmon Creek Medical Center
-
Contato:
- Joseph Jura, Dr
-
-
Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Recrutamento
- Medical College of Wisconsin
-
Contato:
- Jayshil Patel
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Nutrition Education Program
Nutrition education for family members of an elderly critically ill patient
|
Outros nomes:
|
|
Experimental: Decision Support Program
Decision support education for family members of an elderly critically ill patient
|
Outros nomes:
|
|
Sem intervenção: Cuidados usuais
Sem intervenção
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Nutritional adequacy during the ICU stay
Prazo: Up to 30 days in ICU
|
Up to 30 days in ICU
|
|
|
Consumption of Oral Nutritional Supplements
Prazo: First four weeks once on ward
|
First four weeks once on ward
|
|
|
Intake on hospital wards (3 day calorie count)
Prazo: First four weeks once on ward
|
First four weeks once on ward
|
|
|
Hand grip strength
Prazo: At or before hospital discharge or up to 90 days
|
Hydraulic hand dynamometer
|
At or before hospital discharge or up to 90 days
|
|
Use of shared-decision making (OPTION tool)
Prazo: Within first week in ICU
|
Within first week in ICU
|
|
|
Change in decisional conflict
Prazo: 1 week
|
10-item Decisional Conflict Scale
|
1 week
|
|
Family satisfaction with decision-making
Prazo: 1 week
|
1 week
|
|
|
Overall family satisfaction with ICU
Prazo: At ICU discharge, an average of 12 days
|
At ICU discharge, an average of 12 days
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Daren Heyland, MD, Clinical Evaluation Research Unit
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IMPACT
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .