Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant (BMTSLPRCT)
Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients
The purpose of the proposed research study is to evaluate whether bone marrow transplant patients prefer the Stanford letter advance care planning tool to the standard Advance directive.
Completion of advance care planning prior to BMT is very important, but not often done. The investigators believe that the Stanford Letter will be preferred by patients and will allow them to feel more comfortable and share more of their wishes with family members and the medical team.
Visão geral do estudo
Status
Descrição detalhada
PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).
SECONDARY OBJECTIVES:
I. To evaluate differences in patient preference for choice to prolong life following completion of the ACP tool in each group.
II. To assess uncertainty with decision making regarding end of life care following completion of the ACP tool in each group.
III. To explore patient understanding of and satisfaction with the ACP tool in each group.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION): Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
GROUP II (CONTROL): Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the California (CA) Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
After completion of study, patients are followed up periodically.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Palo Alto, California, Estados Unidos, 94304
- Stanford University, School of Medicine
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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:
- All BMT patients at Stanford who are adults and give consent
Exclusion Criteria:
- Less than 18 years of age
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: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP.
Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT.
After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
|
Estudos auxiliares
Receive and complete the Stanford Letter
Outros nomes:
Undergo semi-structured, research staff-led interview
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|
Comparador Ativo: Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP.
Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT.
After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
|
Estudos auxiliares
Undergo semi-structured, research staff-led interview
Receive and complete the CA Advance Health Care Directive Form
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record
Prazo: Up to BMT day 0
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The chi-square (X^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
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Up to BMT day 0
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation
Prazo: Up to BMT day 0
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The X^2 test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
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Up to BMT day 0
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Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results
Prazo: Up to BMT day 0
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Will be measured using the DCS uncertainty sub-scale (score 0-15; higher score indicates greater uncertainty).
Scores from each group will be compared by t-tests.
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Up to BMT day 0
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Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
Prazo: within 28 days of ACP completion
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Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making).
Likert scores of understanding of the ACP from each group will be summarized and compared by t-tests.
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within 28 days of ACP completion
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Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
Prazo: within 28 days of ACP completion
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Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making).
Scores from each group will be compared by t-tests.
Likert scores of satisfaction with the ACP will be summarized and compared by group using t-tests.
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within 28 days of ACP completion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lori Muffly, MD, Stanford Cancer Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Outros números de identificação do estudo
- BMT313
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