跳至主要内容
临床试验/NCT04859114
NCT04859114已完成不适用

Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 1,052 人开始时间: 2021年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,052
试验地点
1
主要终点
Hypothetical Treatment Choice

研究概览

简要总结

Women recruited from the internet will be put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information on the likelihood of survival and chance of disability for babies born at this gestational age.

Participants will be randomized to receive this outcome data in one of three formats: as text-only, in a static pictograph, or in an iterative pictograph. Participants will also be randomized to seeing the chance of survival as 30% or 60%.

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.

详细描述

A recent study by Kidszun et al. (2020) concluded that for mothers placed in a hypothetical situation of choosing between comfort care and intensive care at 22 weeks gestation, treatment choice was not influenced by the chance of survival. Specifically, there was no difference in treatment choice between moms who were told the baby would have a 30% chance of survival and moms who were told the baby would have a 60% chance of survival.

The study was conducted using a written vignette that included a paragraph on the chance of survival and the chance of disability among the survivors.

In this study, we will adapt the vignette the Kidszun et al. (2020) team used, and provide it to an internet-based sample of women. In this vignette, participants will be put in a hypothetical situation of being in labor at 22 weeks of pregnancy, provided a description of the treatment choices of intensive care or comfort care, and provided data on outcome information at this gestational age.

After reading the vignette, participants will be randomized to view either: a repeat of the text information on outcome data, a static pictograph, or an iterative pictograph. Participants will also be randomized to seeing the chance of survival as 30% or 60%, making this a 2 (chance of survival) x 3 (data presentation format) between-subjects experiment.

After viewing a repeat of the outcome information, participants will be asked to choose between intensive care or comfort care for their hypothetical child. We will also collect information on values, religiosity, health literacy, subjective numeracy, a subjective probability estimate, and demographics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Women who have:
  • •had a child,
  • •are currently of child-bearing age (defined as 18-45)
  • •and who live in the U.S.

排除标准

  • •Those unable to read English
  • •Those who only could complete the survey on their phone. (For formatting purposes, a tablet or computer is necessary.)

研究组 & 干预措施

Text-only outcome data, 30% survival

Active Comparator

Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% chance of survival.

干预措施: Format of outcome data presentation (Behavioral)

Text-only outcome data, 30% survival

Active Comparator

Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% chance of survival.

干预措施: Displayed chance of survival (Behavioral)

Text-only outcome data, 60% survival

Active Comparator

Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 60% chance of survival.

干预措施: Format of outcome data presentation (Behavioral)

Text-only outcome data, 60% survival

Active Comparator

Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 60% chance of survival.

干预措施: Displayed chance of survival (Behavioral)

Static pictograph outcome data, 30% survival

Experimental

Participants in this arm view a static pictograph displaying the outcome data and showing a 30% chance of survival.

干预措施: Format of outcome data presentation (Behavioral)

Static pictograph outcome data, 30% survival

Experimental

Participants in this arm view a static pictograph displaying the outcome data and showing a 30% chance of survival.

干预措施: Displayed chance of survival (Behavioral)

Static pictograph outcome data, 60% survival

Experimental

Participants in this arm view a static pictograph displaying the outcome data and showing a 60% chance of survival.

干预措施: Format of outcome data presentation (Behavioral)

Static pictograph outcome data, 60% survival

Experimental

Participants in this arm view a static pictograph displaying the outcome data and showing a 60% chance of survival.

干预措施: Displayed chance of survival (Behavioral)

Iterative pictograph outcome data, 30% survival

Experimental

Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% chance of survival.

干预措施: Format of outcome data presentation (Behavioral)

Iterative pictograph outcome data, 30% survival

Experimental

Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% chance of survival.

干预措施: Displayed chance of survival (Behavioral)

Iterative pictograph outcome data, 60% survival

Experimental

Participants in this arm view an iterative pictograph displaying the outcome data and showing a 60% chance of survival.

干预措施: Format of outcome data presentation (Behavioral)

Iterative pictograph outcome data, 60% survival

Experimental

Participants in this arm view an iterative pictograph displaying the outcome data and showing a 60% chance of survival.

干预措施: Displayed chance of survival (Behavioral)

结局指标

主要结局

Hypothetical Treatment Choice

时间窗: Assessed immediately post-intervention

Participant's hypothetical treatment choice of either palliative care or intensive care. Participants are told: "If the child was actually born shortly after the conversation described above, which treatment would you prefer if you were in this situation?" and given the options of "Palliative care treatment" or "Intensive care treatment". This variable is assessed for the frequency of each option chosen.

次要结局

  • Values: Quality of Life or Sanctity of Life(Assessed post-intervention, immediately after treatment choice.)
  • Preference for Medical Autonomy(Assessed post-intervention, immediately after treatment choice)
  • Subjective Sense of Probability(Assessed post-intervention, immediately after treatment choice.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mir A Basir

Associate Professor of Pediatrics

Medical College of Wisconsin

研究点 (1)

Loading locations...

相似试验