Framing and Decision Making in Neonatology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elke U. Weber, Columbia University
ClinicalTrials.gov Identifier:
NCT01421238
First received: August 8, 2011
Last updated: November 20, 2012
Last verified: November 2012

August 8, 2011
November 20, 2012
May 2006
April 2007   (final data collection date for primary outcome measure)
Number of participants deciding to resuscitate an extremely premature infant. [ Time Frame: Up to 1 year from the start of the study ] [ Designated as safety issue: No ]
Each participants decisional outcome (resuscitation or comfort care) per survey arm will be counted. We expect 60% of the participants will decide to resuscite in both arms. We expect that 90% will select resuscitation in those who receive the resuscitation default and 60% will select resuscitation in the comfort care default
Same as current
Complete list of historical versions of study NCT01421238 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Framing and Decision Making in Neonatology
Framing and Perinatal Decision Making at Extremes of Prematurity

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Prematurity
  • Framing
  • Perinatal Decision Making
Behavioral: Survey
Participants were randomized to one of two survey groups. In one arm (resuscitation default arm), resuscitation was presented as the course of action that would be followed unless the participant objected. In the other arm (comfort care default arm), comfort care was presented as the course of action that would be followed unless the participant objected.
  • Experimental: Resuscitation Default Arm

    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 []

    Intervention: Behavioral: Survey
  • Experimental: Comfort Care Default Arm

    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 []

    Intervention: Behavioral: Survey
Haward MF, Murphy RO, Lorenz JM. Message framing and perinatal decisions. Pediatrics. 2008 Jul;122(1):109-18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

>18 yo

Exclusion Criteria:

<18 yo

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01421238
AAAB8193
No
Elke U. Weber, Columbia University
Columbia University
Not Provided
Principal Investigator: Ryan Murphy, PhD Columbia University
Principal Investigator: Elke U Weber Columbia University
Columbia University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP