Order Effects of Prematurity Outcome Data

Premature Birth Clinical Trial

Official title:

The Effect of Order of Presenting Survival and Disability Information for Periviable Births on Participant Treatment Choice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269616
• Other study ID #: 2019-121
• Status: Completed
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: December 27, 2019

Study information

• Verified date: February 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: December 27, 2019
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Order of pictographs provided to participants
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).
• Level of description in survival pictograph
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).

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothetical treatment choice	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.	Assessed immediately post-intervention.
Secondary	Religiosity	Participants' religiosity was assessed using the Duke University Religion Index (5-item). Potential scores range from 5-27, with 27 being the most religious.	Assessed post-intervention, immediately after treatment choice.
Secondary	Preference for medical autonomy	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.	Assessed post-intervention, immediately after treatment choice.
Secondary	Values: quality or sanctity of life	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.	Assessed post-intervention, immediately after treatment choice.
Secondary	Numeracy	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.	Assessed post-intervention, immediately after treatment choice.
Secondary	Health literacy	Participants' health literacy was assessed using the single-item Brief Health Literacy screening, which asks, "How confident are you filling out medical forms by yourself? 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 health literacy.	Assessed post-intervention, immediately after treatment choice.
Secondary	Previous NICU exposure	Participants were also asked if they have previously had a child in the NICU, with yes/no answer options.	Assessed post-intervention, immediately after treatment choice.