Decision Aid - Extreme Prematurity

NCT ID: NCT01713894

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-10-15

Brief Summary

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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

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Conditions

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Prematurity; Decision Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Decision Aid

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

Group Type OTHER

Decision Aid

Intervention Type OTHER

Standard

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

Group Type OTHER

Standard

Intervention Type OTHER

Interventions

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Decision Aid

Intervention Type OTHER

Standard

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virtua Health

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Endeavor Health

OTHER

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Ursula Guillen

Principal Investigator; Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ursula Guillen, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Systems

Locations

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Christiana Care Health System

Newark, Delaware, United States

Site Status

Countries

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United States

References

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Guillen U, Mackley A, Laventhal N, Kukora S, Christ L, Derrick M, Batza J, Ghavam S, Kirpalani H. Evaluating the Use of a Decision Aid for Parents Facing Extremely Premature Delivery: A Randomized Trial. J Pediatr. 2019 Jun;209:52-60.e1. doi: 10.1016/j.jpeds.2019.02.023. Epub 2019 Apr 2.

Reference Type DERIVED
PMID: 30952510 (View on PubMed)

Other Identifiers

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Decision Aid - Prematurity

Identifier Type: -

Identifier Source: org_study_id

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