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Decision Aid - Extreme Prematurity

Primary Purpose

Prematurity; Decision Support

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Standard
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prematurity; Decision Support focused on measuring Counseling, Limits of viability

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Christiana Care Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Decision Aid

Standard

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Knowledge

Full Information

First Posted
October 22, 2012
Last Updated
January 10, 2018
Sponsor
Christiana Care Health Services
Collaborators
Virtua Health, University of Michigan, NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT01713894
Brief Title
Decision Aid - Extreme Prematurity
Official Title
Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
October 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christiana Care Health Services
Collaborators
Virtua Health, University of Michigan, NorthShore University HealthSystem

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity; Decision Support
Keywords
Counseling, Limits of viability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision Aid
Arm Type
Other
Arm Description
In this arm of the study, parents will be counseled using a decision aid.
Arm Title
Standard
Arm Type
Other
Arm Description
In this arm of the study, parents will be counseled using current standard methods.
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Type
Other
Intervention Name(s)
Standard
Primary Outcome Measure Information:
Title
Decisional conflict
Description
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 Outcome Measure Information:
Title
Knowledge
Time Frame
within 1 week after consult

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Guillen, MD
Organizational Affiliation
Christiana Care Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30952510
Citation
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.
Results Reference
derived

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Decision Aid - Extreme Prematurity

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