Decision Aid - Extreme Prematurity

Not Applicable

Completed

• Conditions: Prematurity; Decision Support

• 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

Study Timeline

• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-25
• Study Start: 2013-05
• Primary Completion: 2017-10-15
• Study Completion: 2017-10-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12

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

Exclusion Criteria

• Known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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