Effects of Repeated Decision Making Among Surrogates of Seriously Ill Patients
27 de janeiro de 2015 atualizado por: Scott Halpern, University of Pennsylvania
Pilot Study of Repeated Decision Making in Surrogates
Decision making capacity fatigues after repeated decisions similar to skeletal muscle.
The result is decision fatigue, in which subsequent decisions are altered toward the status quo.
Surrogates are at risk for decision fatigue yet it has not been studied.
We propose a randomized study in the outpatient setting in surrogates and patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on surrogate self-control and subsequent choices.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made.
This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue.
People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo.
By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities.
Patients and their surrogates often make complex medical decisions for which they may have little experience.
Although clearly at high risk, decision fatigue has not been studied in this population.
To elucidate these questions, we propose a four-arm study of surrogates and patients in a population at high risk for making complex decisions.
Surrogates will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.
Tipo de estudo
Intervencional
Inscrição (Real)
132
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Perelman Center for Advanced Medicine at the University of Pennsylvania
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patients must have one of the following diagnoses: aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma.
- Patients must have at least one surrogate at their clinic visit who is willing to enroll with them as a pair to be included.
- Surrogates are eligible if an eligible patient identifies them as as a surrogate and both consent for the study.
- All participants must be over the age 18
- All participants must be fluent in English
Exclusion Criteria:
- Patients and surrogates will be excluded if they are illiterate or have a medical condition known to alter Stroop performance. These include individuals who are visually impaired such that they cannot read a computer screen, blind or colorblind, patients given sedating medications during their appointment and individuals with past medical history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness.
- Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the mechanical ventilation hypothetical scenario and the hypothetical life sustaining therapy question.
- Surrogates and patients are ineligible if their paired participant is excluded for any of the above reasons.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: DLST Only
Surrogates will complete the Stroop test then answer the hypothetical life sustaining therapy (LST)
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Experimental: Contemplate only
Surrogates will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question
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Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
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Experimental: Decide with advice
Surrogates will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question.
Within this arm, surrogates will receive two positive recommendations (i.e. to go ahead with the intervention) and two negative recommendations (i.e. to decline the intervention).
These positive and negative recommendations will be randomly assigned upon study enrollment.
With four hypothetical scenarios, there are six possible options for recommendation variations.
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Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
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Experimental: Decide without advice
Surrogates will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question.
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Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Stroop Test Score
Prazo: Approximately 15 minutes
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Measurement of score will be done at the conclusion of instrument completion.
The Stroop test is a standard measure of self control that requires three tasks.
The last task is the most difficult where the participant must suppress the urge to read the word which is the easier task and instead say the color it is printed in.
Standard scoring is the number correct in the Word trial minus the Color-Word trials.
This data will be collected immediately following completion.
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Approximately 15 minutes
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evidence of status quo bias
Prazo: Approximately 10 minutes
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Evidence of status quo bias as assessed by hypothetical decision to limit life sustaining therapy or to continue treatment.
To assess for status quo bias, we will use the following technique: after the initial four hypothetical questions and Stroop testing, participants will be asked a hypothetical question about life sustaining therapy (LST).
In the question, continuing life sustaining therapy will be counted as maintaining the status quo.
This is based on current norms in American health care where life sustaining therapy is continued until a patient or surrogate specifically request otherwise.
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Approximately 10 minutes
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Scott D. Halpern, MD, PhD, University of Pennsylvania
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2012
Conclusão Primária (Real)
1 de abril de 2013
Conclusão do estudo (Real)
1 de abril de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
1 de novembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de novembro de 2012
Primeira postagem (Estimativa)
7 de novembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
29 de janeiro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de janeiro de 2015
Última verificação
1 de janeiro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 816697
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