Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03985852|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Risk Reduction Behavior||Other: Patient Directed Standard of Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1980 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Broadening the Reach, Impact, and Delivery of Genetic Services|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||September 1, 2023|
Active Comparator: Patient Directed Standard of Care
Patients receive pre-test genetic counseling and, if relevant, post-test counseling for a negative result from an automated genetics education assistant.
Other: Patient Directed Standard of Care
The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone.
No Intervention: Enhanced Standard of Care
Patients receive standard counseling from a genetic counselor.
- Completion of genetic testing from electronic health record [ Time Frame: 1 month following pre-test genetic counseling ]Percentage of patients who decide to receive genetic testing
- Completion of genetic counseling from electronic health record [ Time Frame: 1 month after study invitation ]Percentage of patients who decide to receive genetic counseling
- Adherence to management recommendations from genetic counselor: questionnaire [ Time Frame: 8 weeks and 13 months from pre-test counseling ]Adherence to cancer screening and prevention recommendations given by genetic counselor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985852
|Contact: Kimberly Kaphingst, PhDfirstname.lastname@example.org|
|Contact: Kadyn Kimball, BSemail@example.com|