Decision Aid - Extreme Prematurity
This study is not yet open for participant recruitment.
Verified October 2012 by Christiana Care Health Services
Sponsor:
Christiana Care Health Services
Collaborators:
University of Pennsylvania
Beth Israel Deaconess Medical Center
University of Michigan
NorthShore University HealthSystem Research Institute
Information provided by (Responsible Party):
Ursula Guillen, Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01713894
First received: October 22, 2012
Last updated: October 24, 2012
Last verified: October 2012
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Prematurity |
Other: Decision Aid Other: Standard |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Health Services Research |
| Official Title: | Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery |
Further study details as provided by Christiana Care Health Services:
Primary Outcome Measures:
- Decisional conflict [ Designated as safety issue: No ]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 [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Decision Aid
In this arm of the study, parents will be counseled using a decision aid.
|
Other: Decision Aid |
|
Standard
In this arm of the study, parents will be counseled using current standard methods.
|
Other: Standard |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713894
Contacts
| Contact: Ursula Guillen, MD | 302-733-2410 | uguillen@christianacare.org |
| Contact: Amy Mackley, MSN | 302-733-2153 | amackley@christianacare.org |
Sponsors and Collaborators
Christiana Care Health Services
University of Pennsylvania
Beth Israel Deaconess Medical Center
University of Michigan
NorthShore University HealthSystem Research Institute
Investigators
| Principal Investigator: | Ursula Guillen, MD | Christiana Care Health Systems |
More Information
No publications provided
| Responsible Party: | Ursula Guillen, Principal Investigator; Assistant Professor, Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT01713894 History of Changes |
| Other Study ID Numbers: | Decision Aid - Prematurity |
| Study First Received: | October 22, 2012 |
| Last Updated: | October 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Christiana Care Health Services:
|
Counseling Limits of viability |
ClinicalTrials.gov processed this record on May 19, 2013