Framing and Decision Making in Neonatology

NCT01421238 | Completed

• 1 other identifier: AAAB8193
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Framing; Perinatal Decision Making

Keywords

Decision Making; Premature infant; Informed consent; Prematurity; Framing; Negotiation Model

Outcome Measures

Primary Outcomes (1)

• Number of participants deciding to resuscitate an extremely premature infant.

  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

  Up to 1 year from the start of the study

Study Arms (2)

Resuscitation Default Arm

EXPERIMENTAL

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 \[\]

Behavioral: Survey

Comfort Care Default Arm

EXPERIMENTAL

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 \[\]

Behavioral: Survey

Interventions

Survey BEHAVIORAL

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.

Comfort Care Default Arm; Resuscitation Default Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 yo

You may not qualify if:

• \<18 yo

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Center for Decision Sciences

New York, New York, 10027, United States

Location

Related Publications (1)

• Haward MF, Murphy RO, Lorenz JM. Message framing and perinatal decisions. Pediatrics. 2008 Jul;122(1):109-18. doi: 10.1542/peds.2007-0620.

  PMID: 18595993 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ryan Murphy, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Elke U Weber

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jerome A. Chazen Professor of International Business and Professor of Psychology

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 22, 2011
• Study Start: May 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

US (1)