Decision Aid - Extreme Prematurity

Prematurity; Decision Support Clinical Trial

Official title:

Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713894
• Other study ID #: Decision Aid - Prematurity
• Status: Completed
• Phase: N/A
• First received: October 22, 2012
• Last updated: January 10, 2018
• Start date: May 2013
• Est. completion date: October 15, 2017

Study information

• Verified date: January 2018
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 15, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Prematurity; Decision Support

Intervention

Other:
• Decision Aid

• Standard

Locations

Country	Name	City	State
United States	Christiana Care Health System	Newark	Delaware

Sponsors (4)

Lead Sponsor	Collaborator
Christiana Care Health Services	NorthShore University HealthSystem Research Institute, University of Michigan, Virtua Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge		within 1 week after consult