Order Effects of Prematurity Outcome Data

Medical College of Wisconsin

Status: Completed

Conditions: Premature Birth

Treatments: Behavioral: Level of description in survival pictograph; Behavioral: Order of pictographs provided to participants

Study type: Interventional

Funder types: Other

Identifiers

NCT04269616

2019-121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 839 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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839 participants in 4 patient groups

Numerical survival, followed by disability information

Experimental group

Description:

Participants in this arm were presented with a pictograph displaying numerical survival information, followed by a pictograph displaying disability information.

Treatment:

Behavioral: Order of pictographs provided to participants

Behavioral: Level of description in survival pictograph

Survival with description, followed by disability information

Experimental group

Description:

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.

Treatment:

Behavioral: Order of pictographs provided to participants

Behavioral: Level of description in survival pictograph

Disability information, followed by numerical survival

Experimental group

Description:

Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying numerical survival.

Treatment:

Behavioral: Order of pictographs provided to participants

Behavioral: Level of description in survival pictograph

Disability information, followed by survival with description

Experimental group

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.

Treatment:

Behavioral: Order of pictographs provided to participants

Behavioral: Level of description in survival pictograph