Order Effects of Prematurity Outcome Data

NCT04269616 | Completed

• 1 other identifier: 2019-121
• Study Type: interventional
• Target: 839
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Decision making; Neonatal resuscitation; Order effect; Prenatal counseling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Religiosity

  Assessed post-intervention, immediately after treatment choice.

• Preference for medical autonomy

  Assessed post-intervention, immediately after treatment choice.

• Values: quality or sanctity of life

  Assessed post-intervention, immediately after treatment choice.

• Numeracy

  Assessed post-intervention, immediately after treatment choice.

• Health literacy

  Assessed post-intervention, immediately after treatment choice.

Study Arms (4)

Numerical survival, followed by disability information

EXPERIMENTAL

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

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

Survival with description, followed by disability information

EXPERIMENTAL

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.

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

Disability information, followed by numerical survival

EXPERIMENTAL

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

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

Disability information, followed by survival with description

EXPERIMENTAL

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.

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

Interventions

Order of pictographs provided to participants BEHAVIORAL

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).

Disability information, followed by numerical survival; Disability information, followed by survival with description; Numerical survival, followed by disability information; Survival with description, followed by disability information

Level of description in survival pictograph BEHAVIORAL

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).

Disability information, followed by numerical survival; Disability information, followed by survival with description; Numerical survival, followed by disability information; Survival with description, followed by disability information

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The survey was distributed only to women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women of childbearing age (defined as 18-50) living in the U.S.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 between subjects

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 17, 2020
• Study Start: December 23, 2019
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)