Decision Aid - Extreme Prematurity

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Christiana Care Health Services
Sponsor:
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: February 18, 2014
Last verified: February 2014
  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
Masking: Open Label
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 [ Time Frame: within 1 week after consult ] [ 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 [ Time Frame: within 1 week after consult ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19713
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: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Counseling
Limits of viability

ClinicalTrials.gov processed this record on July 24, 2014