Prematurity; Decision Support
Conditions
Keywords
Counseling, Limits of viability
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?
Interventions
OTHERDecision Aid
OTHERStandard
Sponsors
Virtua Health
University of Michigan
Endeavor Health
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Knowledge | within 1 week after consult |
Countries
United States
Outcome results
None listed