- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01561885
Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways (CHAMP-Path)
A Pragmatic Randomized Controlled Trial of Patient-Centered Integrated Clinical Pathways Based Versus Usual Care in an Academic Center: National Guard Health Affairs Western Region Experience
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a pragmatic randomized controlled trial. To date, there is a scarcity of randomized controlled trials looking at pathway-based, patient-centered healthcare versus usual care in several high-risk or high volume diagnoses that account for the vast majority of hospitalizations in medical settings.
In this study, the pathway care intervention is a collaborative effort that involves healthcare professionals from multiple departments, including pharmacists, health educators, nurses, social workers, nutritionists, and quality management.
For patients allocated to the usual care, these healthcare professionals will deliver standardized care when consulted. For pathway care patients, this collaborative healthcare will be default.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Makkah
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Jeddah, Makkah, Arábia Saudita, 21423
- King Khalid National Guard Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria (Overall Criteria):
- One principle diagnosis
- Hemodynamic Stability
Inclusion Criteria (Specific to each Diagnosis):
Acute Venous Thromboembolism:
- New onset / in-patient
Acute Kidney Injury:
- Patients with increased serum creatinine of more than 50% from baseline
Community Acquired Pneumonia:
- Age limit
Adult Left Ventricular Heart Failure:
- Age limit
Asthma
- Acute exacerbation of Asthma
Exclusion Criteria (Overall Criteria):
- Intensive Care Unit (ICU) patients
- Pregnancy
- Exclusion Criteria (Specific to each Diagnosis):
Acute Venous Thromboembolism:
- Hemodynamic instability (Systolic Blood Pressure (SBP) less than 90 mmHg or massive Pulmonary Embolism (PE)
- PE patients with an sPESI Score ≥ 1
Acute Kidney Injury:
- Critical care patients (ICU, Coronary Care Unit, burn units)
- Stage 4 and 5 chronic kidney diseases
- Kidney allograft recipients
- Obstructive uropathy
- Glomerulonephritis
- Interstitial nephritis
Community Acquired Pneumonia:
- Intensive Care Unit (ICU) patients
- Pregnancy
Adult Left Ventricular Heart Failure:
- All non-cardiogenic pulmonary edema
- Patients requiring Inotropic agents
Asthma
- Patients with Chronic Obstructive Pulmonary Disease (COPD) and Bronchiectasis
- Severe Asthma (Peak Expiratory Flow Rate (PEFR) less than 40 percent)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Patients on Pathway Care
|
Patients who are randomly allocated to Pathway Care will be treated by the Pathway Clinical Teaching Unit as well as other collaborative healthcare professionals (pharmacists, nurses, health educators, nutritionists, and social workers).
The Pathway Care physicians will have access to the Clinical Care Plan on the QuadraMed, which is a detailed, organized, day-to-day treatment plan that includes pre-set orders and medications.
Physicians for the patients on Usual Care will not have access to this information, and the collaborative healthcare will only be provided upon consultation.
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Sem intervenção: Patients on Usual Care
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Decrease in length of hospital stay by two days
Prazo: During hospitalization period of 7 to 10 days
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During hospitalization period of 7 to 10 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
30-Day Rehospitalization
Prazo: After discharge up to 30 days
|
To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis
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After discharge up to 30 days
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Determinants of the Length of Stay
Prazo: Upon admission until discharge
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Upon admission until discharge
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Pathway Care Specific Clinical Outcomes
Prazo: Upon admission until discharge
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For pathway care, there are specific targeted outcomes that ought to be met.
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Upon admission until discharge
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mujtaba Quadri, MD, National Guard Health Affairs
- Investigador principal: Sherine Esmail, PharmD, National Guard Health Affairs
- Investigador principal: Saliman Karsou, MD, National Guard Health Affairs
- Investigador principal: Abdulhameed Gasim, MD, National Guard Health Affairs
- Investigador principal: Zeyad Zahrani, MD, National Guard Health Affairs
- Investigador principal: Majed Al Jeraisy, PharmD, King Abdullah International Medical Research Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RC 10/134/J
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