Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling
1 other identifier
interventional
1,052
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedStudy Start
First participant enrolled
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2021
CompletedResults Posted
Study results publicly available
November 24, 2023
CompletedNovember 24, 2023
November 1, 2023
15 days
April 21, 2021
May 10, 2022
November 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Values: Quality of Life or Sanctity of Life
Assessed post-intervention, immediately after treatment choice.
Preference for Medical Autonomy
Assessed post-intervention, immediately after treatment choice
Subjective Sense of Probability
Assessed post-intervention, immediately after treatment choice.
Study Arms (6)
Text-only outcome data, 30% survival
ACTIVE COMPARATORParticipants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% chance of survival.
Text-only outcome data, 60% survival
ACTIVE COMPARATORParticipants in this arm view a repeat of the outcome data in a text-only format, displaying a 60% chance of survival.
Static pictograph outcome data, 30% survival
EXPERIMENTALParticipants in this arm view a static pictograph displaying the outcome data and showing a 30% chance of survival.
Static pictograph outcome data, 60% survival
EXPERIMENTALParticipants in this arm view a static pictograph displaying the outcome data and showing a 60% chance of survival.
Iterative pictograph outcome data, 30% survival
EXPERIMENTALParticipants in this arm view an iterative pictograph displaying the outcome data and showing a 30% chance of survival.
Iterative pictograph outcome data, 60% survival
EXPERIMENTALParticipants in this arm view an iterative pictograph displaying the outcome data and showing a 60% chance of survival.
Interventions
Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.
In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Eligibility Criteria
You may qualify if:
- Women who have:
- had a child,
- are currently of child-bearing age (defined as 18-45)
- and who live in the U.S.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
McDonnell SM, Basir MA, Yan K, Liegl MN, Windschitl PD. Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling: A Randomized, Controlled Trial. J Pediatr. 2023 Jun;257:113382. doi: 10.1016/j.jpeds.2023.02.026. Epub 2023 Mar 7.
PMID: 36894129DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mir A Basir
- Organization
- Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
April 21, 2021
First Posted
April 26, 2021
Study Start
June 7, 2021
Primary Completion
June 22, 2021
Study Completion
June 22, 2021
Last Updated
November 24, 2023
Results First Posted
November 24, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share