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| ID | Type | Description | Link |
|---|---|---|---|
| AHRQ Grant # R18-HS10214 |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). We hypothesize that, compared to controls, women randomized to view PT Tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.
We will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the University of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San Francisco, or California Pacific Medical Center (CPMC). After completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. Patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the State of California. Patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Women in this arm view the interactive, computerized, prenatal testing decision tool (PT Tool) we created. |
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| 2 | Active Comparator | Women in this arm view the age-appropriate computerized version of the educational pamphlet on prenatal testing developed and distributed by the State of California |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control - computerized age-appropriate prenatal testing educational brochure | Other | Computerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Kuppermann, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19104360 | Derived | Kuppermann M, Norton ME, Gates E, Gregorich SE, Learman LA, Nakagawa S, Feldstein VA, Lewis J, Washington AE, Nease RF Jr. Computerized prenatal genetic testing decision-assisting tool: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):53-63. doi: 10.1097/AOG.0b013e31818e7ec4. |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| PT Tool - interactive, computerized, prenatal testing decision tool | Other | An interactive, computerized prenatal testing decision-assisting tool (PT Tool). |
|
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |