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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859114
• Other study ID #: 2021-121
• Status: Completed
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: June 22, 2021

Study information

• Verified date: November 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1052
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Format of outcome data presentation
Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.
• Displayed chance of survival
In the outcome data provided to participants, they view either a 30% or 60% chance of survival.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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 from "No chance of survival" to "Definitely will survive". Responses will be coded numerically on a 100-point scale, with 0 representing "No chance of survival" to 100 representing "Definitely will survive".	Assessed post-intervention, immediately after treatment choice.