Decision Aid - Extreme Prematurity

Christiana Care Health Services200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

200

Conditions

Prematurity; Decision Support

Interventions

Decision AidOTHER

StandardOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Christiana Care Health System

Newark, Delaware, United States

Outcomes

Primary Outcomes

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

Time frame: within 1 week after consult

Secondary Outcomes

Knowledge

Time frame: within 1 week after consult

Data from ClinicalTrials.gov

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