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Clinical Trials/NCT01713894
NCT01713894
Completed
Not Applicable

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

Christiana Care Health Services1 site in 1 country200 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prematurity; Decision Support
Sponsor
Christiana Care Health Services
Enrollment
200
Locations
1
Primary Endpoint
Decisional conflict
Status
Completed
Last Updated
8 years ago

Overview

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?

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
October 15, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ursula Guillen

Principal Investigator; Assistant Professor

Christiana Care Health Services

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Decisional conflict

Time Frame: 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 Outcomes

  • Knowledge(within 1 week after consult)

Study Sites (1)

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