Decision Aid - Extreme Prematurity

Christiana Care Health Services

Status: Completed

Conditions: Prematurity; Decision Support

Treatments: Other: Decision Aid; Other: Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT01713894

Decision Aid - Prematurity

Details and patient eligibility

About

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?

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Decision Aid

Other group

Description:

In this arm of the study, parents will be counseled using a decision aid.

Treatment:

Other: Decision Aid

Standard

Other group

Description:

In this arm of the study, parents will be counseled using current standard methods.

Treatment:

Other: Standard