Clinical trial NCT01421238: Framing and Decision Making in Neonatology
Official title: Framing and Perinatal Decision Making at Extremes of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Framing
Perinatal Decision Making
Keywords: Decision Making
Premature infant
Informed consent
Prematurity
Framing
Negotiation Model
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

\>18 yo

Exclusion Criteria:

\<18 yo

Primary outcomes:
measure: Number of participants deciding to resuscitate an extremely premature infant.
timeFrame: Up to 1 year from the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Center for Decision Sciences
state: New York
Study officials:
affiliation: Columbia University
name: Ryan Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Elke U Weber
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haward MF, Murphy RO, Lorenz JM. Message framing and perinatal decisions. Pediatrics. 2008 Jul;122(1):109-18. doi: 10.1542/peds.2007-0620.