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

• ClinicalTrials.gov Identifier: NCT04859114
• Recruitment Status: Completed
• First Posted: April 26, 2021
• Last Update Posted: September 5, 2021
• Sponsor: Medical College of Wisconsin
• Information provided by (Responsible Party): Mir A Basir, Medical College of Wisconsin

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.

Condition or disease	Intervention/treatment	Phase
Premature Birth	Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1182 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: 2x3 between subjects
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth
• Actual Study Start Date: June 7, 2021
• Actual Primary Completion Date: June 22, 2021
• Actual Study Completion Date: June 22, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Hypothetical treatment choice [ Time Frame: Assessed immediately post-intervention ]
   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 :

1. Values: Quality of life or Sanctity of life [ Time Frame: Assessed post-intervention, immediately after treatment choice. ]
   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.
2. Preference for medical autonomy [ Time Frame: Assessed post-intervention, immediately after treatment choice ]
   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."
3. Health literacy [ Time Frame: Assessed post-intervention, immediately after treatment choice. ]
   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.
4. Religiosity [ Time Frame: Assessed post-intervention, immediately after treatment choice. ]
   Participants' religiosity was assessed using the Duke University Religion Index (5-item). Potential scores range from 5-27, with 27 being the most religious.
5. Subjective numeracy [ Time Frame: Assessed post-intervention, immediately after treatment choice. ]
   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?"
6. Subjective sense of probability [ Time Frame: Assessed post-intervention, immediately after treatment choice. ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: The survey was distributed only to women.
• Accepts Healthy Volunteers: Yes

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.)

Contacts and Locations

Locations

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

More Information

• Responsible Party: Mir A Basir, Associate Professor of Pediatrics, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT04859114
• Other Study ID Numbers: 2021-121
• First Posted: April 26, 2021
• Last Update Posted: September 5, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mir A Basir, Medical College of Wisconsin:

decision making; neonatal resuscitation; risk communication; prenatal counseling

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications