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Framing and Decision Making in Neonatology

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Columbia University

Status

Completed

Conditions

Prematurity
Framing
Perinatal Decision Making

Treatments

Behavioral: Survey

Study type

Interventional

Funder types

Other

Identifiers

NCT01421238
AAAB8193

Details and patient eligibility

About

The purpose of this study is to study how people make decisions regarding delivery room management for infants born extremely premature when survival and long term outcomes are uncertain. The hypothesis is that the way in which information is presented will impact decisions.

There have been many advances in neonatal care in recent decades. However, the investigators do not know if these children will grow up to be healthy or if they will have problems with mental retardation, behavior or physical handicaps. In these circumstances, where the medical profession cannot predict what sort of life a child will have, parents have a choice of having intensive care started or of allowing the baby to die naturally. The age most often cited by physicians at which this care is optional and under parental discretion is 23 weeks gestation.

The purpose of this study was to ask people, recruited through the world wide web, what they would want for the doctor to do in the case of a hypothetical 23 week premature delivery in order to evaluate the decision process and the presence of autonomous choice. This study had two parts. The first part, presented outcome information in 2 different ways -either as survival and lack of severe disability or as mortality and presence of severe disability. The results of the first part have been published (Message Framing and Perinatal Decisions, Pediatrics, 2008). The second part, investigated whether the way in which the way in which delivery room management options were presented- either as agreeing with a course of action or opting out- impacted resuscitation decisions. This part was administered as a separate survey to a different sample of participants at a later date. The remainder of the questionnaires asked demographic and opinion questions as a means to assess variables that may influence how people respond to the information they receive.

Enrollment

350 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

>18 yo

Exclusion criteria

<18 yo

Trial design

350 participants in 2 patient groups

Resuscitation Default Arm
Experimental group
Description:
After receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information: The doctor goes on to say that at this hospital infants born at 23 weeks will receive resuscitation, unless their parents object. If you decline resuscitation please check the box below: Please check if you decline resuscitation \[\]
Treatment:
Behavioral: Survey
Comfort Care Default Arm
Experimental group
Description:
After receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information: The doctor goes on to say that at this hospital infants born at 23 weeks will receive comfort care, unless their parents object. If you decline comfort care please check the box below: Please check if you decline comfort care \[\]
Treatment:
Behavioral: Survey

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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