Decision Aid - Extreme Prematurity
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?
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery|
- Decisional conflict [ Time Frame: within 1 week after consult ] [ Designated as safety issue: No ]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
- Knowledge [ Time Frame: within 1 week after consult ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
In this arm of the study, parents will be counseled using a decision aid.
|Other: Decision Aid|
In this arm of the study, parents will be counseled using current standard methods.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713894
|Contact: Ursula Guillen, MDfirstname.lastname@example.org|
|Contact: Amy Mackley, MSNemail@example.com|
|United States, Delaware|
|Christiana Care Health System||Recruiting|
|Newark, Delaware, United States, 19713|
|Principal Investigator:||Ursula Guillen, MD||Christiana Care Health Systems|