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

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival

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.

• Study Type: Interventional
• Enrollment (Actual): 1182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Text-only outcome data, 30% survival; Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% chance of survival.	Behavioral: Format of outcome data presentation; Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.; Behavioral: Displayed chance of survival; In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Active Comparator: Text-only outcome data, 60% survival; Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 60% chance of survival.	Behavioral: Format of outcome data presentation; Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.; Behavioral: Displayed chance of survival; In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Experimental: Static pictograph outcome data, 30% survival; Participants in this arm view a static pictograph displaying the outcome data and showing a 30% chance of survival.	Behavioral: Format of outcome data presentation; Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.; Behavioral: Displayed chance of survival; In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Experimental: Static pictograph outcome data, 60% survival; Participants in this arm view a static pictograph displaying the outcome data and showing a 60% chance of survival.	Behavioral: Format of outcome data presentation; Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.; Behavioral: Displayed chance of survival; In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Experimental: Iterative pictograph outcome data, 30% survival; Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% chance of survival.	Behavioral: Format of outcome data presentation; Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.; Behavioral: Displayed chance of survival; In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Experimental: Iterative pictograph outcome data, 60% survival; Participants in this arm view an iterative pictograph displaying the outcome data and showing a 60% chance of survival.	Behavioral: Format of outcome data presentation; Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.; Behavioral: Displayed chance of survival; In the outcome data provided to participants, they view either a 30% or 60% chance of survival.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothetical treatment choice	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.	Assessed immediately post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Religiosity	Participants' religiosity was assessed using the Duke University Religion Index (5-item). Potential scores range from 5-27, with 27 being the most religious.	Assessed post-intervention, immediately after treatment choice.
Health literacy	Participants' health literacy was assessed using the single-item Brief Health Literacy screening, which asks, "How confident are you filling out medical forms by yourself? 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 health literacy.	Assessed post-intervention, immediately after treatment choice.
Values: Quality of life or Sanctity of life	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.	Assessed post-intervention, immediately after treatment choice.
Preference for medical autonomy	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 medical 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. 4) I always prefer to make my own decisions."	Assessed post-intervention, immediately after treatment choice
Subjective numeracy	Participants' subjective sense of their own numeracy skills will be assessed using a 3-item version of the Subjective Numeracy Scale (SNS-3). On a 6-point scale, from "Not good at all" to "Extremely good", participants respond to: 1) "How good are you at working with fractions?", 2) "How good are you at figuring out how much a shirt will cost if it is 25% off?", and 3) "How often do you find numerical information to be useful?"	Assessed post-intervention, immediately after treatment choice.
Subjective sense of probability	After reporting an objective value of the probability of survival that has been described to them in the vignette and intervention, participants report their subjective sense of probability. Specifically, they will read: "Assume again that your baby was born prematurely at 22 weeks and given intensive care treatment. The doctor gave you the same information you read earlier. At a gut level, what would you believe is your own baby's actual chance of survival? Please click somewhere along the bar below to indicate your response." Participants use a slider scale below the item to respond. Responses will be coded numerically on a 100-point scale.	Assessed post-intervention, immediately after treatment choice.

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: decision making; neonatal resuscitation; risk communication; prenatal counseling
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2021-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No