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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Wisconsin
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
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).
|
|
Experimentální: 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.
|
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).
|
|
Experimentální: 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.
|
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).
|
|
Experimentální: 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.
|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hypothetical treatment choice
Časové okno: 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.
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Assessed immediately post-intervention.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Religiozita
Časové okno: Posouzeno po intervenci, ihned po volbě léčby.
|
Religiozita účastníků byla hodnocena pomocí indexu náboženství Duke University (5 položek).
Potenciální skóre se pohybuje od 5 do 27, přičemž 27 je nejvíce nábožensky založený.
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Posouzeno po intervenci, ihned po volbě léčby.
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Preference for medical autonomy
Časové okno: 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
Časové okno: 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
Časové okno: 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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Zdravotní gramotnost
Časové okno: Posouzeno po intervenci, ihned po volbě léčby.
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Zdravotní gramotnost účastníků byla hodnocena pomocí jednopoložkového screeningu Brief Health Literacy, který se ptá: „Nakolik jste si jisti, že sami vyplňujete lékařské formuláře?
Velmi / Docela / Trochu / Trochu / Vůbec ne." Účastníci, kteří odpověděli poněkud, trochu nebo vůbec, byli považováni za osoby s nízkou zdravotní gramotností.
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Posouzeno po intervenci, ihned po volbě léčby.
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Previous NICU exposure
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2019-121
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