Clinical trial NCT04859114: Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling
Official title: Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: decision making
neonatal resuscitation
risk communication
prenatal counseling
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 1052
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x3 between subjects
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Hypothetical Treatment Choice
timeFrame: Assessed immediately post-intervention
Secondary outcomes:
measure: Values: Quality of Life or Sanctity of Life
timeFrame: Assessed post-intervention, immediately after treatment choice.
measure: Preference for Medical Autonomy
timeFrame: Assessed post-intervention, immediately after treatment choice
measure: Subjective Sense of Probability
timeFrame: Assessed post-intervention, immediately after treatment choice.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: