Premature BirthNCT04859114
Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling
A study testing Format of outcome data presentation and Displayed chance of survival in people with Premature Birth, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Format of outcome data presentation and Displayed chance of survival
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,052 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who have:
- had a child,
- are currently of child-bearing age (defined as 18-45)
- and who live in the U.S.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- Format of outcome data presentation, Displayed chance of survival
- Keywords
- decision making, neonatal resuscitation, risk communication, prenatal counseling
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Format of outcome data presentationBehavioural
Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.
Displayed chance of survivalBehavioural
In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
| Study group | Role | What they receive |
|---|---|---|
| Text-only outcome data, 30% survival | Active comparator | Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% chance of survival. Receives: Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival |
| Text-only outcome data, 60% survival | Active comparator | Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 60% chance of survival. Receives: Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival |
| Static pictograph outcome data, 30% survival | Experimental | Participants in this arm view a static pictograph displaying the outcome data and showing a 30% chance of survival. Receives: Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival |
| Static pictograph outcome data, 60% survival | Experimental | Participants in this arm view a static pictograph displaying the outcome data and showing a 60% chance of survival. Receives: Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival |
| Iterative pictograph outcome data, 30% survival | Experimental | Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% chance of survival. Receives: Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival |
| Iterative pictograph outcome data, 60% survival | Experimental | Participants in this arm view an iterative pictograph displaying the outcome data and showing a 60% chance of survival. Receives: Behavioral: Format of outcome data presentation; Behavioral: Displayed chance of survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed immediately post-intervention
Secondary outcomes (3)
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.
Measured: 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."
Measured: 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 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".
Measured: Assessed post-intervention, immediately after treatment choice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start7 Jun 2021
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x3 between subjects
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mir A Basir, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859114
- Sponsor's protocol ID
- 2021-121
- Status last verified
- Nov 2023
- First submitted
- 21 Apr 2021
- Last updated
- 24 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36894129
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth
- ClinicalTrials.gov ID
- NCT04859114
- Acronym / sponsor ID
- 2021-121
- Conditions
- Premature Birth
- Keywords
- decision making, neonatal resuscitation, risk communication, prenatal counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,052 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Posted 24 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- 2x3 between subjects
| Arm | Type | Receives |
|---|---|---|
| Text-only outcome data, 30% survival | Active comparator | Behavioral: Format of outcome data presentation, Behavioral: Displayed chance of survivalParticipants 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 comparator | Behavioral: Format of outcome data presentation, Behavioral: Displayed chance of survivalParticipants 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 | Experimental | Behavioral: Format of outcome data presentation, Behavioral: Displayed chance of survivalParticipants in this arm view a static pictograph displaying the outcome data and showing a 30% chance of survival. |
| Static pictograph outcome data, 60% survival | Experimental | Behavioral: Format of outcome data presentation, Behavioral: Displayed chance of survivalParticipants in this arm view a static pictograph displaying the outcome data and showing a 60% chance of survival. |
| Iterative pictograph outcome data, 30% survival | Experimental | Behavioral: Format of outcome data presentation, Behavioral: Displayed chance of survivalParticipants in this arm view an iterative pictograph displaying the outcome data and showing a 30% chance of survival. |
| Iterative pictograph outcome data, 60% survival | Experimental | Behavioral: Format of outcome data presentation, Behavioral: Displayed chance of survivalParticipants in this arm view an iterative pictograph displaying the outcome data and showing a 60% chance of survival. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- had a child,
- are currently of child-bearing age (defined as 18-45)
- and who live in the U.S.
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Format of outcome data presentationOutcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. | Behavioural | Iterative pictograph outcome data, 30% survival, Iterative pictograph outcome data, 60% survival, Static pictograph outcome data, 30% survival, Static pictograph outcome data, 60% survival, Text-only outcome data, 30% survival, Text-only outcome data, 60% survival |
| Displayed chance of survivalIn the outcome data provided to participants, they view either a 30% or 60% chance of survival. | Behavioural | Iterative pictograph outcome data, 30% survival, Iterative pictograph outcome data, 60% survival, Static pictograph outcome data, 30% survival, Static pictograph outcome data, 60% survival, Text-only outcome data, 30% survival, Text-only outcome data, 60% survival |
Primary outcome
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.
3 secondary outcomes
Values: Quality of Life or Sanctity of Life
Time frame: Assessed post-intervention, immediately after treatment choice.
Preference for Medical Autonomy
Time frame: Assessed post-intervention, immediately after treatment choice
Subjective Sense of Probability
Time frame: Assessed post-intervention, immediately after treatment choice.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36894129McDonnell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Format of outcome data presentation and Displayed chance of survival in people with Premature Birth, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothetical Treatment Choice (time frame: Assessed immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.