Clinical trial NCT04269616: Order Effects of Prematurity Outcome Data
Official title: The Effect of Order of Presenting Survival and Disability Information for Periviable Births on Participant Treatment Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Decision making
Neonatal resuscitation
Order effect
Prenatal counseling
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 839
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 between subjects
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Hypothetical treatment choice
timeFrame: Assessed immediately post-intervention.
Secondary outcomes:
measure: Religiosity
timeFrame: Assessed post-intervention, immediately after treatment choice.
measure: Preference for medical autonomy
timeFrame: Assessed post-intervention, immediately after treatment choice.
measure: Values: quality or sanctity of life
timeFrame: Assessed post-intervention, immediately after treatment choice.
measure: Numeracy
timeFrame: Assessed post-intervention, immediately after treatment choice.
measure: Health literacy
timeFrame: Assessed post-intervention, immediately after treatment choice.
measure: Previous NICU exposure
timeFrame: Assessed post-intervention, immediately after treatment choice.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: