Premature Birth
Conditions
Keywords
decision making, neonatal resuscitation, risk communication, prenatal counseling
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.
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.
Interventions
BEHAVIORALFormat of outcome data presentation
Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.
BEHAVIORALDisplayed chance of survival
In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
2x3 between subjects
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypothetical Treatment Choice | 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
| Measure | Time frame | Description |
|---|---|---|
| Values: Quality of Life or Sanctity of Life | 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. |
| Preference for Medical Autonomy | 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. |
| Subjective Sense of Probability | 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text-only Outcome Data, 30% Chance of Survival Participants in this arm are provided a 30% chance of survival seen by repeat of the outcome data in a text-only format.
Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. | 176 |
| Static Pictograph Outcome Data, 30% Chance of Survival Participants in this arm are provided a 30% chance of survival seen by a static pictograph displaying the outcome data.
Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. | 179 |
| Iterative Pictograph Outcome Data, 30% Survival Participants in this arm are provided a 30% chance of survival, seen by an iterative pictograph displaying the outcome data.
Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. | 176 |
| Text-only Outcome Data, 60% Chance of Survival Participants in this arm are provided a 60% chance of survival seen by repeat of the outcome data in a text-only format.
Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. | 177 |
| Static Pictograph Outcome Data, 60% Chance of Survival Participants in this arm are provided a 60% chance of survival seen by a static pictograph displaying the outcome data.
Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. | 177 |
| Iterative Pictograph Outcome Data, 60% Survival Participants in this arm are provided a 60% chance of survival, seen by an iterative pictograph displaying the outcome data.
Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. | 167 |
| Total | 1,052 |
Baseline characteristics
| Characteristic | Text-only Outcome Data, 30% Chance of Survival | Total | Iterative Pictograph Outcome Data, 60% Survival | Static Pictograph Outcome Data, 60% Chance of Survival | Text-only Outcome Data, 60% Chance of Survival | Iterative Pictograph Outcome Data, 30% Survival | Static Pictograph Outcome Data, 30% Chance of Survival |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 7.9 | 34.0 years STANDARD_DEVIATION 7.5 | 33.6 years STANDARD_DEVIATION 7.4 | 33.8 years STANDARD_DEVIATION 7.7 | 34.6 years STANDARD_DEVIATION 8 | 34.1 years STANDARD_DEVIATION 7.2 | 34.1 years STANDARD_DEVIATION 7 |
| Education 2-year college degree | 10 Participants | 94 Participants | 20 Participants | 14 Participants | 13 Participants | 15 Participants | 22 Participants |
| Education 4-year college degree | 47 Participants | 296 Participants | 45 Participants | 41 Participants | 57 Participants | 54 Participants | 52 Participants |
| Education 8th grade or less | 1 Participants | 9 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants |
| Education 9th-12th grade, no diploma | 14 Participants | 52 Participants | 5 Participants | 9 Participants | 11 Participants | 8 Participants | 5 Participants |
| Education Graduate or professional degree | 44 Participants | 219 Participants | 27 Participants | 47 Participants | 37 Participants | 33 Participants | 31 Participants |
| Education High school diploma or equivalent | 44 Participants | 246 Participants | 45 Participants | 39 Participants | 33 Participants | 39 Participants | 46 Participants |
| Education Preferred not to answer | 0 Participants | 6 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Education Some college | 16 Participants | 130 Participants | 20 Participants | 26 Participants | 25 Participants | 23 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 172 Participants | 24 Participants | 27 Participants | 28 Participants | 32 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 136 Participants | 844 Participants | 136 Participants | 140 Participants | 144 Participants | 140 Participants | 148 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 36 Participants | 7 Participants | 10 Participants | 5 Participants | 4 Participants | 5 Participants |
| Previous Neonatal Intensive Care Unit exposure Do not know | 4 Participants | 31 Participants | 4 Participants | 7 Participants | 10 Participants | 3 Participants | 3 Participants |
| Previous Neonatal Intensive Care Unit exposure No | 127 Participants | 712 Participants | 114 Participants | 117 Participants | 103 Participants | 122 Participants | 129 Participants |
| Previous Neonatal Intensive Care Unit exposure Prefers not to answer | 2 Participants | 13 Participants | 3 Participants | 2 Participants | 6 Participants | 0 Participants | 0 Participants |
| Previous Neonatal Intensive Care Unit exposure Yes | 43 Participants | 296 Participants | 46 Participants | 51 Participants | 58 Participants | 51 Participants | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 16 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 60 Participants | 8 Participants | 13 Participants | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 169 Participants | 32 Participants | 20 Participants | 33 Participants | 32 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 28 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 132 Participants | 776 Participants | 120 Participants | 135 Participants | 129 Participants | 127 Participants | 133 Participants |
| Region of Enrollment United States | 176 participants | 1052 participants | 167 participants | 177 participants | 177 participants | 176 participants | 179 participants |
| Sex: Female, Male Female | 176 Participants | 1052 Participants | 167 Participants | 177 Participants | 177 Participants | 176 Participants | 179 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Assessed immediately post-intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text-only Outcome Data, 30% Survival | Hypothetical Treatment Choice | Chose intensive care | 130 Participants |
| Text-only Outcome Data, 30% Survival | Hypothetical Treatment Choice | Chose palliative care | 46 Participants |
| Text-only Outcome Data, 60% Survival | Hypothetical Treatment Choice | Chose intensive care | 135 Participants |
| Text-only Outcome Data, 60% Survival | Hypothetical Treatment Choice | Chose palliative care | 42 Participants |
| Static Pictograph Outcome Data, 30% Survival | Hypothetical Treatment Choice | Chose intensive care | 143 Participants |
| Static Pictograph Outcome Data, 30% Survival | Hypothetical Treatment Choice | Chose palliative care | 36 Participants |
| Static Pictograph Outcome Data, 60% Survival | Hypothetical Treatment Choice | Chose intensive care | 126 Participants |
| Static Pictograph Outcome Data, 60% Survival | Hypothetical Treatment Choice | Chose palliative care | 51 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Hypothetical Treatment Choice | Chose intensive care | 129 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Hypothetical Treatment Choice | Chose palliative care | 47 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Hypothetical Treatment Choice | Chose intensive care | 123 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Hypothetical Treatment Choice | Chose palliative care | 44 Participants |
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.
Time frame: Assessed post-intervention, immediately after treatment choice
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text-only Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I would prefer to have the doctor make medical decisions for me most of the time. | 43 Participants |
| Text-only Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I always prefer to make my own decisions. | 33 Participants |
| Text-only Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I would prefer to make my own medical decisions most of the time. | 64 Participants |
| Text-only Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I always prefer to have the doctor make medical decisions for me. | 36 Participants |
| Text-only Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I would prefer to have the doctor make medical decisions for me most of the time. | 55 Participants |
| Text-only Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I always prefer to make my own decisions. | 32 Participants |
| Text-only Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I always prefer to have the doctor make medical decisions for me. | 49 Participants |
| Text-only Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I would prefer to make my own medical decisions most of the time. | 41 Participants |
| Static Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I always prefer to make my own decisions. | 36 Participants |
| Static Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I would prefer to have the doctor make medical decisions for me most of the time. | 44 Participants |
| Static Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I would prefer to make my own medical decisions most of the time. | 53 Participants |
| Static Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I always prefer to have the doctor make medical decisions for me. | 46 Participants |
| Static Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I would prefer to make my own medical decisions most of the time. | 49 Participants |
| Static Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I always prefer to make my own decisions. | 28 Participants |
| Static Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I would prefer to have the doctor make medical decisions for me most of the time. | 58 Participants |
| Static Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I always prefer to have the doctor make medical decisions for me. | 42 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I would prefer to have the doctor make medical decisions for me most of the time. | 44 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I always prefer to make my own decisions. | 33 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I would prefer to make my own medical decisions most of the time. | 46 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Preference for Medical Autonomy | Responded I always prefer to have the doctor make medical decisions for me. | 53 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I always prefer to make my own decisions. | 24 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I always prefer to have the doctor make medical decisions for me. | 48 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I would prefer to have the doctor make medical decisions for me most of the time. | 35 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Preference for Medical Autonomy | Responded I would prefer to make my own medical decisions most of the time. | 60 Participants |
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.
Time frame: Assessed post-intervention, immediately after treatment choice.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text-only Outcome Data, 30% Survival | Subjective Sense of Probability | 61.5 units on a scale | Standard Deviation 29.9 |
| Text-only Outcome Data, 60% Survival | Subjective Sense of Probability | 66.1 units on a scale | Standard Deviation 25 |
| Static Pictograph Outcome Data, 30% Survival | Subjective Sense of Probability | 64.8 units on a scale | Standard Deviation 27.7 |
| Static Pictograph Outcome Data, 60% Survival | Subjective Sense of Probability | 65.4 units on a scale | Standard Deviation 25.9 |
| Iterative Pictograph Outcome Data, 30% Survival | Subjective Sense of Probability | 65.7 units on a scale | Standard Deviation 26.7 |
| Iterative Pictograph Outcome Data, 60% Survival | Subjective Sense of Probability | 62.7 units on a scale | Standard Deviation 26 |
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.
Time frame: Assessed post-intervention, immediately after treatment choice.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text-only Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is somewhat more important | 31 Participants |
| Text-only Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is somewhat more important | 42 Participants |
| Text-only Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is much more important | 80 Participants |
| Text-only Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is much more important | 23 Participants |
| Text-only Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is somewhat more important | 45 Participants |
| Text-only Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is much more important | 90 Participants |
| Text-only Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is somewhat more important | 26 Participants |
| Text-only Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is much more important | 16 Participants |
| Static Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is much more important | 85 Participants |
| Static Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is much more important | 22 Participants |
| Static Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is somewhat more important | 30 Participants |
| Static Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is somewhat more important | 42 Participants |
| Static Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is somewhat more important | 21 Participants |
| Static Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is much more important | 16 Participants |
| Static Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is much more important | 93 Participants |
| Static Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is somewhat more important | 47 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is much more important | 90 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is somewhat more important | 38 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is much more important | 17 Participants |
| Iterative Pictograph Outcome Data, 30% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is somewhat more important | 31 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is much more important | 19 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Preserving life is somewhat more important | 26 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is much more important | 78 Participants |
| Iterative Pictograph Outcome Data, 60% Survival | Values: Quality of Life or Sanctity of Life | Quality of life is somewhat more important | 44 Participants |