We propose to determine the impact of providing complete information about all prenatal tests for chromosomal disorders to women of all ages and allowing them to make informed choices regarding which tests, if any, to undergo. Specifically, we plan to update a validated prenatal testing decision-assisting tool (""""""""PT Tool"""""""") to incorporate all new screening options and make it more accessible to a lower literacy population. We then will conduct a randomized controlled trial comparing the effect of an """"""""informed free choice"""""""" approach to testing, consisting of providing information regarding and access to all prenatal testing options, to that of usual care among a racially/ethnically, socioeconomically and age-diverse population of pregnant women. The primary goal is to generate evidence needed to determine whether clinicians should consider an alternative to the current practice of using only risk-based thresholds for invasive testing and adopt a strategy that would enable all women to make informed choices that are reflective of their own values and preferences. A second goal is to expand PT Tool to include new screening tests and modify it for use by lower literacy women.
Specific aims are to: 1) determine which testing strategies are selected by women who receive complete information on all testing options and have all the options available to them compared to women receiving usual care; 2) update both the English- and Spanish-language versions of PT Tool to include information on new screening options and modify them for use by lower literacy women; 3) assess the impact of receiving complete information on and access to all testing options and having all options available on knowledge, risk comprehension, and decisional conflict compared to usual care; 4) evaluate the cost effectiveness of an """"""""informed free choice"""""""" approach to providing prenatal testing services compared to usual care. In short, this study will generate a useful decision-assisting tool and provide information for use in designing cost-effective testing programs that allow for variation in preferences. ? ?

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
1R01HD049686-01A1
Application #
7032858
Study Section
Health Services Organization and Delivery Study Section (HSOD)
Program Officer
Engelson, Gilian
Project Start
2006-05-01
Project End
2011-02-28
Budget Start
2006-05-01
Budget End
2007-02-28
Support Year
1
Fiscal Year
2006
Total Cost
$299,974
Indirect Cost
Name
University of California San Francisco
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Molina, Fabiola; Dehlendorf, Christine; Gregorich, Steven E et al. (2018) Women's preferences for and experiences with prenatal genetic testing decision making: Sociodemographic disparities in preference-concordant decision making. Patient Educ Couns :
Bryant, Allison S; Norton, Mary E; Nakagawa, Sanae et al. (2015) Variation in Women's Understanding of Prenatal Testing. Obstet Gynecol 125:1306-12
Kuppermann, Miriam; Pena, Sherri; Bishop, Judith T et al. (2014) Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA 312:1210-7