NCT04859114

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

Completed NA Results posted Last updated 24 November 2023

What this trial tests

NA trial testing Format of outcome data presentation in Premature Birth in 1,052 participants. Completed in 22 June 2021.

Timeline

7 June 2021

Primary endpoint
22 June 2021

22 June 2021

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	other
Enrollment	1,052
Start date	7 June 2021
Primary completion	22 June 2021
Estimated completion	22 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Format of outcome data presentation
• Displayed chance of survival

Conditions studied

• Premature Birth — all drugs for Premature Birth →

Sponsor

Medical College of Wisconsin

Who can join

Adults 18 to 45, female only, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hypothetical Treatment Choice Primary · 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.

Group	Value	95% CI
Text-only Outcome Data, 30% Survival	130
Text-only Outcome Data, 60% Survival	135
Static Pictograph Outcome Data, 30% Survival	143
Static Pictograph Outcome Data, 60% Survival	126
Iterative Pictograph Outcome Data, 30% Survival	129
Iterative Pictograph Outcome Data, 60% Survival	123
Text-only Outcome Data, 30% Survival	46
Text-only Outcome Data, 60% Survival	42
Static Pictograph Outcome Data, 30% Survival	36
Static Pictograph Outcome Data, 60% Survival	51
Iterative Pictograph Outcome Data, 30% Survival	47
Iterative Pictograph Outcome Data, 60% Survival	44

Values: Quality of Life or Sanctity of Life Secondary · 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.

Group	Value	95% CI
Text-only Outcome Data, 30% Survival	80
Text-only Outcome Data, 60% Survival	90
Static Pictograph Outcome Data, 30% Survival	85
Static Pictograph Outcome Data, 60% Survival	93
Iterative Pictograph Outcome Data, 30% Survival	90
Iterative Pictograph Outcome Data, 60% Survival	78
Text-only Outcome Data, 30% Survival	42
Text-only Outcome Data, 60% Survival	45
Static Pictograph Outcome Data, 30% Survival	42
Static Pictograph Outcome Data, 60% Survival	47
Iterative Pictograph Outcome Data, 30% Survival	38
Iterative Pictograph Outcome Data, 60% Survival	44
Text-only Outcome Data, 30% Survival	31
Text-only Outcome Data, 60% Survival	26
Static Pictograph Outcome Data, 30% Survival	30
Static Pictograph Outcome Data, 60% Survival	21
Iterative Pictograph Outcome Data, 30% Survival	31
Iterative Pictograph Outcome Data, 60% Survival	26
Text-only Outcome Data, 30% Survival	23
Text-only Outcome Data, 60% Survival	16
Static Pictograph Outcome Data, 30% Survival	22
Static Pictograph Outcome Data, 60% Survival	16
Iterative Pictograph Outcome Data, 30% Survival	17
Iterative Pictograph Outcome Data, 60% Survival	19

Preference for Medical Autonomy Secondary · 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."

Group	Value	95% CI
Text-only Outcome Data, 30% Survival	36
Text-only Outcome Data, 60% Survival	49
Static Pictograph Outcome Data, 30% Survival	46
Static Pictograph Outcome Data, 60% Survival	42
Iterative Pictograph Outcome Data, 30% Survival	53
Iterative Pictograph Outcome Data, 60% Survival	48
Text-only Outcome Data, 30% Survival	43
Text-only Outcome Data, 60% Survival	55
Static Pictograph Outcome Data, 30% Survival	44
Static Pictograph Outcome Data, 60% Survival	58
Iterative Pictograph Outcome Data, 30% Survival	44
Iterative Pictograph Outcome Data, 60% Survival	35
Text-only Outcome Data, 30% Survival	64
Text-only Outcome Data, 60% Survival	41
Static Pictograph Outcome Data, 30% Survival	53
Static Pictograph Outcome Data, 60% Survival	49
Iterative Pictograph Outcome Data, 30% Survival	46
Iterative Pictograph Outcome Data, 60% Survival	60
Text-only Outcome Data, 30% Survival	33
Text-only Outcome Data, 60% Survival	32
Static Pictograph Outcome Data, 30% Survival	36
Static Pictograph Outcome Data, 60% Survival	28
Iterative Pictograph Outcome Data, 30% Survival	33
Iterative Pictograph Outcome Data, 60% Survival	24

Subjective Sense of Probability Secondary · 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 "N

Group	Value	95% CI
Text-only Outcome Data, 30% Survival	61.5	± 29.9
Text-only Outcome Data, 60% Survival	66.1	± 25.0
Static Pictograph Outcome Data, 30% Survival	64.8	± 27.7
Static Pictograph Outcome Data, 60% Survival	65.4	± 25.9
Iterative Pictograph Outcome Data, 30% Survival	65.7	± 26.7
Iterative Pictograph Outcome Data, 60% Survival	62.7	± 26.0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling: A Randomized, Controlled Trial.
   McDonnell SM, Basir MA, Yan K, Liegl MN, et al · · 2023 · cited 6× · PMID 36894129 · DOI 10.1016/j.jpeds.2023.02.026