Premature BirthNCT04269616
Order Effects of Prematurity Outcome Data
A study testing Order of pictographs provided to participants and Level of description in survival pictograph in people with Premature Birth, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Women recruited from the internet were put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information in the form of pictographs about survival and disability of babies born at this gestational age. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Order of pictographs provided to participants and Level of description in survival pictograph
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 839 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2019to 27 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of childbearing age (defined as 18-50) living in the U.S.
Who cannot join
- Minors, those unable to read English, and those who only could complete the survey on their phone. (For formatting purposes, a tablet or computer was 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: The Effect of Order of Presenting Survival and Disability Information for Periviable Births on Participant Treatment Choice
Women recruited from the internet were put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information in the form of pictographs about survival and disability of babies born at this gestational age.
Participants were randomized to receive these pictographs in a different order (survival or disability first) and to receive descriptiveness level of survival (just numerical information, or also description of course of NICU stay).
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
The National Institute of Child Health and Human Development (NICHD) Workshop on Periviable Birth recommended that information on the chance of survival and risk of disability should be provided separately. The order in which information is presented can affect memory, persuasiveness, and treatment choice, but the effect of order of information presentation in the context of neonatal resuscitation has received little attention. Additionally, the effect of including a description of the long and intense time in the neonatal intensive care unit (NICU) on parental treatment decision making is also unexplored. Current evidence suggests that pictographs best convey numerical information to parents.
Three pictographs were developed based on NICHD data for 22 weeks gestational age (GA) babies who received intensive care. One pictograph displayed information on the rates of disability in the babies who survive. Two pictographs displayed information about how many babies born at 22 weeks survive, with one of these pictographs including a description of the average course of NICU stay.
An internet survey was sent to a U.S. representative sample of women of child-bearing age. A vignette including background on prematurity and the treatment options of intensive care or comfort care for a baby born at 22 weeks GA was presented. Participants viewed the pictographs, evenly randomized to one of four experimental conditions (order of information presentation x level of description of NICU course). Participants were then asked to choose intensive care or comfort care. Participant religiosity, values (quality vs. sanctity of life), autonomy preferences in medical decision making, previous NICU exposure, numeracy, and health literacy were also assessed.
- Conditions
- Premature Birth
- Being tested
- Order of pictographs provided to participants, Level of description in survival pictograph
- Keywords
- Decision making, Neonatal resuscitation, Order effect, 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.
Order of pictographs provided to participantsBehavioural
The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e. survival or disability information first).
Level of description in survival pictographBehavioural
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e. only numerical data, or also a description of course of NICU stay).
| Study group | Role | What they receive |
|---|---|---|
| Numerical survival, followed by disability information | Experimental | Participants in this arm were presented with a pictograph displaying numerical survival information, followed by a pictograph displaying disability information. Receives: Behavioral: Order of pictographs provided to participants; Behavioral: Level of description in survival pictograph |
| Survival with description, followed by disability information | Experimental | Participants in this arm were presented with a pictograph displaying survival information including the average course of stay in the NICU, followed by a pictograph displaying disability information. Receives: Behavioral: Order of pictographs provided to participants; Behavioral: Level of description in survival pictograph |
| Disability information, followed by numerical survival | Experimental | Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying numerical survival. Receives: Behavioral: Order of pictographs provided to participants; Behavioral: Level of description in survival pictograph |
| Disability information, followed by survival with description | Experimental | Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying survival information including the average course of stay in the NICU. Receives: Behavioral: Order of pictographs provided to participants; Behavioral: Level of description in survival pictograph |
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 comfort care or intensive care. Participants were told: "Your doctor asks you what treatment option you want to choose," and given the options of "I would want the doctors to provide the baby intensive care / comfort care." This dichotomous variable is assessed for the frequency of each option chosen.
Measured: Assessed immediately post-intervention.
Secondary outcomes (6)
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.
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 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, or 4) I always prefer to make my own decisions." Score ranging from 1-4, with 4 being the maximum preference for medical autonomy.
Measured: Assessed post-intervention, immediately after treatment choice.
Values: quality 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.
Numeracy
Participants' numeracy levels were assessed by using an adapted item from the Subjective Numeracy Scale: "How good are you at figuring out how much a $20 shirt will cost if it is 25% off? 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 numeracy.
Measured: Assessed post-intervention, immediately after treatment choice.
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.
Measured: Assessed post-intervention, immediately after treatment choice.
Previous NICU exposure
Participants were also asked if they have previously had a child in the NICU, with yes/no answer options.
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 posted17 Feb 2020
- Study start23 Dec 2019
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2x2 between subjects
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269616
- Sponsor's protocol ID
- 2019-121
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Order of Presenting Survival and Disability Information for Periviable Births on Participant Treatment Choice
- ClinicalTrials.gov ID
- NCT04269616
- Acronym / sponsor ID
- 2019-121
- Conditions
- Premature Birth
- Keywords
- Decision making, Neonatal resuscitation, Order effect, Prenatal counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
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 were put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information in the form of pictographs about survival and disability of babies born at this gestational age.
Participants were randomized to receive these pictographs in a different order (survival or disability first) and to receive descriptiveness level of survival (just numerical information, or also description of course of NICU stay).
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
The National Institute of Child Health and Human Development (NICHD) Workshop on Periviable Birth recommended that information on the chance of survival and risk of disability should be provided separately. The order in which information is presented can affect memory, persuasiveness, and treatment choice, but the effect of order of information presentation in the context of neonatal resuscitation has received little attention. Additionally, the effect of including a description of the long and intense time in the neonatal intensive care unit (NICU) on parental treatment decision making is also unexplored. Current evidence suggests that pictographs best convey numerical information to parents.
Three pictographs were developed based on NICHD data for 22 weeks gestational age (GA) babies who received intensive care. One pictograph displayed information on the rates of disability in the babies who survive. Two pictographs displayed information about how many babies born at 22 weeks survive, with one of these pictographs including a description of the average course of NICU stay.
An internet survey was sent to a U.S. representative sample of women of child-bearing age. A vignette including background on prematurity and the treatment options of intensive care or comfort care for a baby born at 22 weeks GA was presented. Participants viewed the pictographs, evenly randomized to one of four experimental conditions (order of information presentation x level of description of NICU course). Participants were then asked to choose intensive care or comfort care. Participant religiosity, values (quality vs. sanctity of life), autonomy preferences in medical decision making, previous NICU exposure, numeracy, and health literacy were also assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2x2 between subjects
| Arm | Type | Receives |
|---|---|---|
| Numerical survival, followed by disability information | Experimental | Behavioral: Order of pictographs provided to participants, Behavioral: Level of description in survival pictographParticipants in this arm were presented with a pictograph displaying numerical survival information, followed by a pictograph displaying disability information. |
| Survival with description, followed by disability information | Experimental | Behavioral: Order of pictographs provided to participants, Behavioral: Level of description in survival pictographParticipants in this arm were presented with a pictograph displaying survival information including the average course of stay in the NICU, followed by a pictograph displaying disability information. |
| Disability information, followed by numerical survival | Experimental | Behavioral: Order of pictographs provided to participants, Behavioral: Level of description in survival pictographParticipants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying numerical survival. |
| Disability information, followed by survival with description | Experimental | Behavioral: Order of pictographs provided to participants, Behavioral: Level of description in survival pictographParticipants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying survival information including the average course of stay in the NICU. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women of childbearing age (defined as 18-50) living in the U.S.
Key exclusion criteria (1 listed)
- Minors, those unable to read English, and those who only could complete the survey on their phone. (For formatting purposes, a tablet or computer was 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 |
|---|---|---|
| Order of pictographs provided to participantsThe pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e. survival or disability information first). | Behavioural | Disability information, followed by numerical survival, Disability information, followed by survival with description, Numerical survival, followed by disability information, Survival with description, followed by disability information |
| Level of description in survival pictographThe pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e. only numerical data, or also a description of course of NICU stay). | Behavioural | Disability information, followed by numerical survival, Disability information, followed by survival with description, Numerical survival, followed by disability information, Survival with description, followed by disability information |
Primary outcome
Hypothetical treatment choice
Time frame: Assessed immediately post-intervention.
Participant's hypothetical treatment choice of either comfort care or intensive care. Participants were told: "Your doctor asks you what treatment option you want to choose," and given the options of "I would want the doctors to provide the baby intensive care / comfort care." This dichotomous variable is assessed for the frequency of each option chosen.
6 secondary outcomes
Religiosity
Time frame: Assessed post-intervention, immediately after treatment choice.
Preference for medical autonomy
Time frame: Assessed post-intervention, immediately after treatment choice.
Values: quality or sanctity of life
Time frame: Assessed post-intervention, immediately after treatment choice.
Numeracy
Time frame: Assessed post-intervention, immediately after treatment choice.
Health literacy
Time frame: Assessed post-intervention, immediately after treatment choice.
Previous NICU exposure
Time frame: Assessed post-intervention, immediately after treatment choice.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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 Order of pictographs provided to participants and Level of description in survival pictograph 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 1 inclusion and 1 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 17 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 17 Feb 2020.