Order Effects of Prematurity Outcome Data
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Medical College of Wisconsin
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Women of childbearing age (defined as 18-50) living in the U.S.
Exclusion Criteria:
- 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.)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Numerical survival, followed by disability information
Participants in this arm were presented with a pictograph displaying numerical survival information, followed by a pictograph displaying disability information.
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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).
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).
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Experimenteel: Survival with description, followed by disability information
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.
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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).
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).
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Experimenteel: Disability information, followed by numerical survival
Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying numerical survival.
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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).
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).
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Experimenteel: Disability information, followed by survival with description
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.
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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).
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).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Hypothetical treatment choice
Tijdsspanne: Assessed immediately post-intervention.
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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.
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Assessed immediately post-intervention.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Religiositeit
Tijdsspanne: Beoordeeld na de interventie, direct na de behandelingskeuze.
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De religiositeit van de deelnemers werd beoordeeld met behulp van de Duke University Religion Index (5 items).
Potentiële scores variëren van 5-27, waarbij 27 de meest religieuze is.
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Beoordeeld na de interventie, direct na de behandelingskeuze.
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Preference for medical autonomy
Tijdsspanne: Assessed post-intervention, immediately after treatment choice.
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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.
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Assessed post-intervention, immediately after treatment choice.
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Values: quality or sanctity of life
Tijdsspanne: Assessed post-intervention, immediately after treatment choice.
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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.
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Assessed post-intervention, immediately after treatment choice.
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Numeracy
Tijdsspanne: Assessed post-intervention, immediately after treatment choice.
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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.
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Assessed post-intervention, immediately after treatment choice.
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Gezondheidsgeletterdheid
Tijdsspanne: Beoordeeld na de interventie, direct na de behandelingskeuze.
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De gezondheidsvaardigheden van de deelnemers werden beoordeeld met behulp van de korte screening op gezondheidsvaardigheden met één item, waarin werd gevraagd: "Hoe zeker bent u van het zelf invullen van medische formulieren?
Extreem / Tamelijk / Een beetje / Een beetje / Helemaal niet." Deelnemers die een beetje, een beetje of helemaal niet antwoordden, werden beschouwd als laaggeletterd op het gebied van gezondheid.
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Beoordeeld na de interventie, direct na de behandelingskeuze.
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Previous NICU exposure
Tijdsspanne: Assessed post-intervention, immediately after treatment choice.
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Participants were also asked if they have previously had a child in the NICU, with yes/no answer options.
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Assessed post-intervention, immediately after treatment choice.
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Medewerkers en onderzoekers
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Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2019-121
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