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

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Format of outcome data presentation
Displayed chance of survival
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Birth focused on measuring decision making, neonatal resuscitation, risk communication, prenatal counseling

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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.)

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Text-only outcome data, 30% survival

Text-only outcome data, 60% survival

Static pictograph outcome data, 30% survival

Static pictograph outcome data, 60% survival

Iterative pictograph outcome data, 30% survival

Iterative pictograph outcome data, 60% survival

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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."
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.
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.
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?"
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.

Full Information

First Posted
April 21, 2021
Last Updated
August 30, 2021
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04859114
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
decision making, neonatal resuscitation, risk communication, prenatal counseling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x3 between subjects
Masking
Participant
Allocation
Randomized
Enrollment
1182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text-only outcome data, 30% survival
Arm Type
Active Comparator
Arm Description
Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% chance of survival.
Arm Title
Text-only outcome data, 60% survival
Arm Type
Active Comparator
Arm Description
Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 60% chance of survival.
Arm Title
Static pictograph outcome data, 30% survival
Arm Type
Experimental
Arm Description
Participants in this arm view a static pictograph displaying the outcome data and showing a 30% chance of survival.
Arm Title
Static pictograph outcome data, 60% survival
Arm Type
Experimental
Arm Description
Participants in this arm view a static pictograph displaying the outcome data and showing a 60% chance of survival.
Arm Title
Iterative pictograph outcome data, 30% survival
Arm Type
Experimental
Arm Description
Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% chance of survival.
Arm Title
Iterative pictograph outcome data, 60% survival
Arm Type
Experimental
Arm Description
Participants in this arm view an iterative pictograph displaying the outcome data and showing a 60% chance of survival.
Intervention Type
Behavioral
Intervention Name(s)
Format of outcome data presentation
Intervention Description
Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.
Intervention Type
Behavioral
Intervention Name(s)
Displayed chance of survival
Intervention Description
In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Primary Outcome Measure Information:
Title
Hypothetical treatment choice
Description
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.
Time Frame
Assessed immediately post-intervention
Secondary Outcome Measure Information:
Title
Values: Quality of life or Sanctity of life
Description
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.
Time Frame
Assessed post-intervention, immediately after treatment choice.
Title
Preference for medical autonomy
Description
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."
Time Frame
Assessed post-intervention, immediately after treatment choice
Title
Health literacy
Description
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.
Time Frame
Assessed post-intervention, immediately after treatment choice.
Title
Religiosity
Description
Participants' religiosity was assessed using the Duke University Religion Index (5-item). Potential scores range from 5-27, with 27 being the most religious.
Time Frame
Assessed post-intervention, immediately after treatment choice.
Title
Subjective numeracy
Description
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?"
Time Frame
Assessed post-intervention, immediately after treatment choice.
Title
Subjective sense of probability
Description
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.
Time Frame
Assessed post-intervention, immediately after treatment choice.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The survey was distributed only to women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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