- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713894
Decision Aid - Extreme Prematurity
January 10, 2018 updated by: Ursula Guillen, Christiana Care Health Services
Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Delaware
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Newark, Delaware, United States, 19713
- Christiana Care Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Decision Aid
In this arm of the study, parents will be counseled using a decision aid.
|
|
Other: Standard
In this arm of the study, parents will be counseled using current standard methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 1 week after consult
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knowledge
Time Frame: within 1 week after consult
|
within 1 week after consult
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ursula Guillen, MD, Christiana Care Health Systems
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
October 15, 2017
Study Completion (Actual)
October 15, 2017
Study Registration Dates
First Submitted
October 22, 2012
First Submitted That Met QC Criteria
October 24, 2012
First Posted (Estimate)
October 25, 2012
Study Record Updates
Last Update Posted (Actual)
January 12, 2018
Last Update Submitted That Met QC Criteria
January 10, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Decision Aid - Prematurity
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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