Decision Aid - Extreme Prematurity
Not Applicable
Completed
- Conditions
- Prematurity; Decision Support
- Interventions
- Other: Decision AidOther: Standard
- Registration Number
- NCT01713894
- Lead Sponsor
- Christiana Care Health Services
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- physicians who counsel women at the limits of viability
- women who are receiving counseling at the limits of viability
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Exclusion Criteria
- Known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision Aid Decision Aid In this arm of the study, parents will be counseled using a decision aid. Standard Standard In this arm of the study, parents will be counseled using current standard methods.
- Primary Outcome Measures
Name Time Method Decisional conflict within 1 week after consult 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
- Secondary Outcome Measures
Name Time Method Knowledge within 1 week after consult
Trial Locations
- Locations (1)
Christiana Care Health System
🇺🇸Newark, Delaware, United States