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

Medical College of Wisconsin

Status: Completed

Conditions: Premature Birth

Treatments: Behavioral: Displayed chance of survival; Behavioral: Format of outcome data presentation

Study type: Interventional

Funder types: Other

Identifiers

NCT04859114

2021-121

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,052 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Women who have:

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,052 participants in 6 patient groups

Text-only outcome data, 30% survival

Active Comparator group

Description:

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

Treatment:

Behavioral: Displayed chance of survival

Behavioral: Format of outcome data presentation

Text-only outcome data, 60% survival

Active Comparator group

Description:

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

Treatment:

Behavioral: Displayed chance of survival

Behavioral: Format of outcome data presentation

Static pictograph outcome data, 30% survival

Experimental group

Description:

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

Treatment:

Behavioral: Displayed chance of survival

Behavioral: Format of outcome data presentation

Static pictograph outcome data, 60% survival

Experimental group

Description:

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

Treatment:

Behavioral: Displayed chance of survival

Behavioral: Format of outcome data presentation

Iterative pictograph outcome data, 30% survival

Experimental group

Description:

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

Treatment:

Behavioral: Displayed chance of survival

Behavioral: Format of outcome data presentation

Iterative pictograph outcome data, 60% survival

Experimental group

Description:

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

Treatment:

Behavioral: Displayed chance of survival

Behavioral: Format of outcome data presentation