Decision Aid - Extreme Prematurity
Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to assess in a pilot randomized controlled trial the following PICOT question: In parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? Furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 25, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2017
CompletedJanuary 12, 2018
January 1, 2018
4.5 years
October 22, 2012
January 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decisional conflict
Decisional conflict is the state of uncertainty about the course of action to take when making choices involving risk or uncertainty of outcomes. Decisional conflict is assessed using the Decisional Conflict Scale
within 1 week after consult
Secondary Outcomes (1)
Knowledge
within 1 week after consult
Study Arms (2)
Decision Aid
OTHERIn this arm of the study, parents will be counseled using a decision aid.
Standard
OTHERIn this arm of the study, parents will be counseled using current standard methods.
Interventions
Eligibility Criteria
You may qualify if:
- physicians who counsel women at the limits of viability
- women who are receiving counseling at the limits of viability
You may not qualify if:
- Known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christiana Care Health Serviceslead
- Virtua Healthcollaborator
- University of Michigancollaborator
- Endeavor Healthcollaborator
Study Sites (1)
Christiana Care Health System
Newark, Delaware, 19713, United States
Related Publications (1)
Guillen U, Mackley A, Laventhal N, Kukora S, Christ L, Derrick M, Batza J, Ghavam S, Kirpalani H. Evaluating the Use of a Decision Aid for Parents Facing Extremely Premature Delivery: A Randomized Trial. J Pediatr. 2019 Jun;209:52-60.e1. doi: 10.1016/j.jpeds.2019.02.023. Epub 2019 Apr 2.
PMID: 30952510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ursula Guillen, MD
Christiana Care Health Systems
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator; Assistant Professor
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 25, 2012
Study Start
May 1, 2013
Primary Completion
October 15, 2017
Study Completion
October 15, 2017
Last Updated
January 12, 2018
Record last verified: 2018-01