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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02805712
Focused Palliative Care Intervention in Advanced Heart Failure
Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Patients will be assigned to one of two groups a) longitudinal goals of care discussion led by a palliative care-trained social worker or b) usual care + written information regarding advanced directives. The intervention group will be enrolled in the hospital and then be followed longitudinally for 3 months by a palliative care-trained social worker who will shepherd a conversation around prognosis, expectations, and goals of care. The results of these conversations will be documented in the electronic medical record and shared with the clinical team. Clinical symptoms that are identified during these conversations will be evaluated by a Palliative Care Physician who will relay suggestions regarding management to the primary treating clinician. Baseline surveys will assess prognostic awareness, symptom burden, anxiety, depression, and quality of life for both groups. At the conclusion of the study, an individualized follow-up plan will be devised for each patient based on a needs assessment by the study social worker.
Patients assigned to the control/usual care arm will complete the same series of questionnaires as those assigned to the intervention group and will undergo usual in hospital and post-discharge treatment as directed by their care team. All control subjects will receive written Advanced Care planning and Heart Failure education materials as provided routinely to inpatients at Brigham and Women's Hospital. At the 6 month visit following hospitalization, these patients will be asked to complete follow up questionnaires and then will be given the option to participate in the above verbal intervention and guided "Goals and Values" conversation that was provided to the intervention group.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's 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
- Symptomatic Heart Failure (NYHA II-IV)
Hospitalized or recently for acute decompensation with at least one of the following high-risk features
- Prior hospitalization for Heart Failure (HF) within 1 year
- Age > 80 years
- Chronic Kidney Disease (estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/m2)
- Systolic Blood Pressure < 100 mm Hg
- Serum sodium < 130 meq/L
- Cardiogenic Shock (Cardiac Index < 2.0)
- Serious Non-Cardiovascular Illness (e.g. advanced stage cancer, Chronic Obstructive Pulmonary Disease (COPD) , or the like.
- Ability to Provide Informed Consent
- Permission of attending physician
Exclusion Criteria
- Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
- Already enrolled in hospice or receiving outpatient palliative care
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 |
|---|---|
|
Comparador Ativo: Control
Participant will receive usual care for Heart Failure patients, which include standard written material on Advanced Care planning and supportive cardiology/palliative care consult if ordered by attending.
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The control group will receive usual written care material and a palliative care consult if ordered by physician.
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Experimental: Verbal Information and Discussion
Participants will participate in a guided goals of care conversation and the support of a Palliative Care Social Worker who is working closely with the patients' primary cardiology team.
Social worker has ongoing clinical review of participants with a Palliative Care physician who will provide a full medical consult if appropriate.
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Intervention patient will receive a outpatient session with a palliative care social worker in the heart failure clinic two weeks post discharge consent focusing on goals of care.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
Prazo: 6 months
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Assessment tool: Patient Preferences Questionnaire.
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
Prazo: 6 months
|
Chart review of Advanced Care Planning documents and written notes by members of clinical team.
|
6 months
|
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Is there an impact on symptom burden through a palliative care intervention?
Prazo: Three months
|
Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
|
Three months
|
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Is there an impact on perceived level of illness through a palliative care intervention?
Prazo: 6 months
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Assessment tool: EQ visual analogue scale (EQ-VAS)
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6 months
|
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Is there an impact on overall patient well being through a palliative care intervention?
Prazo: Three months
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Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
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Three months
|
|
Is there an impact on depression through a palliative care intervention?
Prazo: 6 months
|
Assessment tool: Patient Health Questionnaire (PHQ-8)
|
6 months
|
|
Is there an impact on anxiety through a palliative care intervention?
Prazo: 6 months
|
Assessment tool: General Anxiety Disorder (GAD-7)
|
6 months
|
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Is there an impact on cost of treatment through a palliative care intervention?
Prazo: 6 months
|
Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.
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6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Akshay S Desai, MPH, MD, Brigham and Women's Hospital
Publicações e links úteis
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
- 2014P001391
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