Trial Outcomes & Findings for Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling (NCT NCT04859114)

Last Updated: 2023-11-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1052 participants

Primary outcome timeframe

Assessed immediately post-intervention

Results posted on

2023-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	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. Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	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. Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	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. Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	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. Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	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. Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	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. Format of outcome data presentation: Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Overall Study STARTED	176	177	179	177	176	167
Overall Study COMPLETED	176	177	179	177	176	167
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Text-only Outcome Data, 30% Chance of Survival n=176 Participants 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.	Static Pictograph Outcome Data, 30% Chance of Survival n=179 Participants 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.	Iterative Pictograph Outcome Data, 30% Survival n=176 Participants 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.	Text-only Outcome Data, 60% Chance of Survival n=177 Participants 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.	Static Pictograph Outcome Data, 60% Chance of Survival n=177 Participants 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.	Iterative Pictograph Outcome Data, 60% Survival n=167 Participants 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.	Total n=1052 Participants Total of all reporting groups
Age, Continuous	33.9 years STANDARD_DEVIATION 7.9 • n=5 Participants	34.1 years STANDARD_DEVIATION 7.0 • n=7 Participants	34.1 years STANDARD_DEVIATION 7.2 • n=5 Participants	34.6 years STANDARD_DEVIATION 8.0 • n=4 Participants	33.8 years STANDARD_DEVIATION 7.7 • n=21 Participants	33.6 years STANDARD_DEVIATION 7.4 • n=8 Participants	34.0 years STANDARD_DEVIATION 7.5 • n=8 Participants
Sex: Female, Male Female	176 Participants n=5 Participants	179 Participants n=7 Participants	176 Participants n=5 Participants	177 Participants n=4 Participants	177 Participants n=21 Participants	167 Participants n=8 Participants	1052 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	35 Participants n=5 Participants	26 Participants n=7 Participants	32 Participants n=5 Participants	28 Participants n=4 Participants	27 Participants n=21 Participants	24 Participants n=8 Participants	172 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=5 Participants	148 Participants n=7 Participants	140 Participants n=5 Participants	144 Participants n=4 Participants	140 Participants n=21 Participants	136 Participants n=8 Participants	844 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants	7 Participants n=8 Participants	36 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	16 Participants n=8 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	16 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	13 Participants n=21 Participants	8 Participants n=8 Participants	60 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants	33 Participants n=4 Participants	20 Participants n=21 Participants	32 Participants n=8 Participants	169 Participants n=8 Participants
Race (NIH/OMB) White	132 Participants n=5 Participants	133 Participants n=7 Participants	127 Participants n=5 Participants	129 Participants n=4 Participants	135 Participants n=21 Participants	120 Participants n=8 Participants	776 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	28 Participants n=8 Participants
Region of Enrollment United States	176 participants n=5 Participants	179 participants n=7 Participants	176 participants n=5 Participants	177 participants n=4 Participants	177 participants n=21 Participants	167 participants n=8 Participants	1052 participants n=8 Participants
Education 8th grade or less	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	9 Participants n=8 Participants
Education 9th-12th grade, no diploma	14 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	9 Participants n=21 Participants	5 Participants n=8 Participants	52 Participants n=8 Participants
Education High school diploma or equivalent	44 Participants n=5 Participants	46 Participants n=7 Participants	39 Participants n=5 Participants	33 Participants n=4 Participants	39 Participants n=21 Participants	45 Participants n=8 Participants	246 Participants n=8 Participants
Education Some college	16 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	25 Participants n=4 Participants	26 Participants n=21 Participants	20 Participants n=8 Participants	130 Participants n=8 Participants
Education 2-year college degree	10 Participants n=5 Participants	22 Participants n=7 Participants	15 Participants n=5 Participants	13 Participants n=4 Participants	14 Participants n=21 Participants	20 Participants n=8 Participants	94 Participants n=8 Participants
Education 4-year college degree	47 Participants n=5 Participants	52 Participants n=7 Participants	54 Participants n=5 Participants	57 Participants n=4 Participants	41 Participants n=21 Participants	45 Participants n=8 Participants	296 Participants n=8 Participants
Education Graduate or professional degree	44 Participants n=5 Participants	31 Participants n=7 Participants	33 Participants n=5 Participants	37 Participants n=4 Participants	47 Participants n=21 Participants	27 Participants n=8 Participants	219 Participants n=8 Participants
Education Preferred not to answer	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	6 Participants n=8 Participants
Previous Neonatal Intensive Care Unit exposure Yes	43 Participants n=5 Participants	47 Participants n=7 Participants	51 Participants n=5 Participants	58 Participants n=4 Participants	51 Participants n=21 Participants	46 Participants n=8 Participants	296 Participants n=8 Participants
Previous Neonatal Intensive Care Unit exposure No	127 Participants n=5 Participants	129 Participants n=7 Participants	122 Participants n=5 Participants	103 Participants n=4 Participants	117 Participants n=21 Participants	114 Participants n=8 Participants	712 Participants n=8 Participants
Previous Neonatal Intensive Care Unit exposure Do not know	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	4 Participants n=8 Participants	31 Participants n=8 Participants
Previous Neonatal Intensive Care Unit exposure Prefers not to answer	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	13 Participants n=8 Participants

PRIMARY outcome

Timeframe: Assessed immediately post-intervention

Outcome measures

Outcome measures
Measure	Text-only Outcome Data, 30% Survival n=176 Participants Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Text-only Outcome Data, 60% Survival n=177 Participants Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Static Pictograph Outcome Data, 30% Survival n=179 Participants Participants in this arm view a static pictograph displaying the outcome data and showing a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Static Pictograph Outcome Data, 60% Survival n=177 Participants Participants in this arm view a static pictograph displaying the outcome data and showing a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Iterative Pictograph Outcome Data, 30% Survival n=176 Participants Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Iterative Pictograph Outcome Data, 60% Survival n=167 Participants Participants in this arm view an iterative pictograph displaying the outcome data and showing a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Hypothetical Treatment Choice Chose intensive care	130 Participants	135 Participants	143 Participants	126 Participants	129 Participants	123 Participants
Hypothetical Treatment Choice Chose palliative care	46 Participants	42 Participants	36 Participants	51 Participants	47 Participants	44 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Text-only Outcome Data, 30% Survival n=176 Participants Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Text-only Outcome Data, 60% Survival n=177 Participants Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Static Pictograph Outcome Data, 30% Survival n=179 Participants Participants in this arm view a static pictograph displaying the outcome data and showing a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Static Pictograph Outcome Data, 60% Survival n=177 Participants Participants in this arm view a static pictograph displaying the outcome data and showing a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Iterative Pictograph Outcome Data, 30% Survival n=176 Participants Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Iterative Pictograph Outcome Data, 60% Survival n=167 Participants Participants in this arm view an iterative pictograph displaying the outcome data and showing a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Values: Quality of Life or Sanctity of Life Quality of life is much more important	80 Participants	90 Participants	85 Participants	93 Participants	90 Participants	78 Participants
Values: Quality of Life or Sanctity of Life Quality of life is somewhat more important	42 Participants	45 Participants	42 Participants	47 Participants	38 Participants	44 Participants
Values: Quality of Life or Sanctity of Life Preserving life is somewhat more important	31 Participants	26 Participants	30 Participants	21 Participants	31 Participants	26 Participants
Values: Quality of Life or Sanctity of Life Preserving life is much more important	23 Participants	16 Participants	22 Participants	16 Participants	17 Participants	19 Participants

SECONDARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Text-only Outcome Data, 30% Survival n=176 Participants Participants in this arm are provided a repeat of the outcome data in a text-only format, displaying a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Text-only Outcome Data, 60% Survival n=177 Participants Participants in this arm view a repeat of the outcome data in a text-only format, displaying a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Static Pictograph Outcome Data, 30% Survival n=179 Participants Participants in this arm view a static pictograph displaying the outcome data and showing a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Static Pictograph Outcome Data, 60% Survival n=177 Participants Participants in this arm view a static pictograph displaying the outcome data and showing a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Iterative Pictograph Outcome Data, 30% Survival n=176 Participants Participants in this arm view an iterative pictograph displaying the outcome data and showing a 30% 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.	Iterative Pictograph Outcome Data, 60% Survival n=167 Participants Participants in this arm view an iterative pictograph displaying the outcome data and showing a 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. Displayed chance of survival: In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
Preference for Medical Autonomy Responded "I always prefer to have the doctor make medical decisions for me."	36 Participants	49 Participants	46 Participants	42 Participants	53 Participants	48 Participants
Preference for Medical Autonomy Responded "I would prefer to have the doctor make medical decisions for me most of the time."	43 Participants	55 Participants	44 Participants	58 Participants	44 Participants	35 Participants
Preference for Medical Autonomy Responded "I would prefer to make my own medical decisions most of the time."	64 Participants	41 Participants	53 Participants	49 Participants	46 Participants	60 Participants
Preference for Medical Autonomy Responded "I always prefer to make my own decisions."	33 Participants	32 Participants	36 Participants	28 Participants	33 Participants	24 Participants

SECONDARY outcome

Timeframe: 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".