Order Effects of Prematurity Outcome Data
The Effect of Order of Presenting Survival and Disability Information for Periviable Births on Participant Treatment Choice
Women recruited from the internet were put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information in the form of pictographs about survival and disability of babies born at this gestational age.
Participants were randomized to receive these pictographs in a different order (survival or disability first) and to receive descriptiveness level of survival (just numerical information, or also description of course of NICU stay).
Participants were then asked to choose between comfort care and intensive care in this situation. Participants' religiosity, value of the sanctity of life, and health literacy were also assessed.
Visão geral do estudo
Status
Condições
Descrição detalhada
The National Institute of Child Health and Human Development (NICHD) Workshop on Periviable Birth recommended that information on the chance of survival and risk of disability should be provided separately. The order in which information is presented can affect memory, persuasiveness, and treatment choice, but the effect of order of information presentation in the context of neonatal resuscitation has received little attention. Additionally, the effect of including a description of the long and intense time in the neonatal intensive care unit (NICU) on parental treatment decision making is also unexplored. Current evidence suggests that pictographs best convey numerical information to parents.
Three pictographs were developed based on NICHD data for 22 weeks gestational age (GA) babies who received intensive care. One pictograph displayed information on the rates of disability in the babies who survive. Two pictographs displayed information about how many babies born at 22 weeks survive, with one of these pictographs including a description of the average course of NICU stay.
An internet survey was sent to a U.S. representative sample of women of child-bearing age. A vignette including background on prematurity and the treatment options of intensive care or comfort care for a baby born at 22 weeks GA was presented. Participants viewed the pictographs, evenly randomized to one of four experimental conditions (order of information presentation x level of description of NICU course). Participants were then asked to choose intensive care or comfort care. Participant religiosity, values (quality vs. sanctity of life), autonomy preferences in medical decision making, previous NICU exposure, numeracy, and health literacy were also assessed.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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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:
- Women of childbearing age (defined as 18-50) living in the U.S.
Exclusion Criteria:
- Minors, those unable to read English, and those who only could complete the survey on their phone. (For formatting purposes, a tablet or computer was necessary.)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Numerical survival, followed by disability information
Participants in this arm were presented with a pictograph displaying numerical survival information, followed by a pictograph displaying disability information.
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The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
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Experimental: Survival with description, followed by disability information
Participants in this arm were presented with a pictograph displaying survival information including the average course of stay in the NICU, followed by a pictograph displaying disability information.
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The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
|
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Experimental: Disability information, followed by numerical survival
Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying numerical survival.
|
The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
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Experimental: Disability information, followed by survival with description
Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying survival information including the average course of stay in the NICU.
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The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
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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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Hypothetical treatment choice
Prazo: Assessed immediately post-intervention.
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Participant's hypothetical treatment choice of either comfort care or intensive care.
Participants were told: "Your doctor asks you what treatment option you want to choose," and given the options of "I would want the doctors to provide the baby intensive care / comfort care."
This dichotomous variable is assessed for the frequency of each option chosen.
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Assessed immediately post-intervention.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Religiosidade
Prazo: Avaliado pós-intervenção, imediatamente após a escolha do tratamento.
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A religiosidade dos participantes foi avaliada por meio do Índice de Religião da Duke University (5 itens).
As pontuações potenciais variam de 5 a 27, sendo 27 a mais religiosa.
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Avaliado pós-intervenção, imediatamente após a escolha do tratamento.
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Preference for medical autonomy
Prazo: Assessed post-intervention, immediately after treatment choice.
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Participants were asked on a 4-point scale their medical autonomy preferences, in the form of: "In making medical decisions: 1) I always prefer to have the doctor make decisions for me, 2) I would prefer to have the doctor make medical decisions for me most of the time, 3) I would prefer to make my own medical decisions most of the time, or 4) I always prefer to make my own decisions."
Score ranging from 1-4, with 4 being the maximum preference for medical autonomy.
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Assessed post-intervention, immediately after treatment choice.
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Values: quality or sanctity of life
Prazo: Assessed post-intervention, immediately after treatment choice.
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Participants answered the following: "In making end-of-life decisions: 1) Quality of life is much more important than preserving life, 2) Quality of life is somewhat more important than preserving life, 3) Preserving life is somewhat more important than quality of life, or 4) Preserving life is much more important than quality of life."
In the range of 1-4, a score of 4 indicated the greatest participant value of sanctity of life.
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Assessed post-intervention, immediately after treatment choice.
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Numeracy
Prazo: Assessed post-intervention, immediately after treatment choice.
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Participants' numeracy levels were assessed by using an adapted item from the Subjective Numeracy Scale: "How good are you at figuring out how much a $20 shirt will cost if it is 25% off?
Extremely / Quite a bit / Somewhat / A little bit / Not at all." Participants who answered somewhat, a little bit, or not at all were considered to have low numeracy.
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Assessed post-intervention, immediately after treatment choice.
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Alfabetização em saúde
Prazo: Avaliado pós-intervenção, imediatamente após a escolha do tratamento.
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A alfabetização em saúde dos participantes foi avaliada usando a triagem Brief Health Literacy de um único item, que pergunta: "Quão confiante você está preenchendo formulários médicos sozinho?
Extremamente / Bastante / Um pouco / Um pouco / Nada." Os participantes que responderam um pouco, um pouco ou nada foram considerados como tendo baixo letramento em saúde.
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Avaliado pós-intervenção, imediatamente após a escolha do tratamento.
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Previous NICU exposure
Prazo: Assessed post-intervention, immediately after treatment choice.
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Participants were also asked if they have previously had a child in the NICU, with yes/no answer options.
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Assessed post-intervention, immediately after treatment choice.
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Colaboradores e Investigadores
Patrocinador
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 (Real)
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
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Outros números de identificação do estudo
- 2019-121
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