Guilford Genomic Medicine Initiative (GGMI) (GGMI)
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|ClinicalTrials.gov Identifier: NCT01372553|
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : April 16, 2014
- Genomic medicine, using genetic information to improve health outcomes, is heralded as the answer to rising medical costs by focusing on prevention and tailored care. Despite its potential, little investigation has focused on how genomic medicine can be applied in health care. To be effective, it requires new ways to learn, deliver, and communicate medical information. It will also raise new ethical questions.
- The overall goal of Guilford Genomic Medicine Initiative (GGMI) is to identify the specific challenges in "re-structuring" an existing medical system to integrate genomic medicine, and create solutions that can be used by other medical systems, such as the extensive military medical care system. To accomplish this goal, GGMI includes the development of a large-scale genomic medicine education initiative targeted at the community, providers, and patients, and a clinical systems model to implement strategies to facilitate the integration of genomic medicine into several pilot practices.
|Condition or disease||Phase|
|Breast Cancer Ovarian Cancer Colon Cancer Thrombophilia||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||1184 participants|
|Official Title:||Guilford Genomic Medicine Initiative (GGMI)|
|Study Start Date :||October 2009|
|Primary Completion Date :||April 2012|
|Study Completion Date :||April 2012|
Family history risk stratification
primary care patients who receive risk stratification and clinical decision support based upon the family health history they entered in to MeTree
- Evaluate effectiveness of family history collection and decision support for increasing appropriate referrals to genetic counselors for patients at risk of hereditary cancer syndromes [ Time Frame: 1 year ]change in appropriate referal to genetic counseling one year before using MeTree compared to one year after.
- Evaluate effectiveness of family history collection and decision support for increasing appropriate screening for breast, colon, and ovarian cancer [ Time Frame: 1 year ]Compare rate of appropriate screening for breast, colon, and ovarian cancer one year prior to using the family history decision support tool and one year after
- Evaluate effectiveness of family history collection and decision support for appropriate risk-based management of thrombosis [ Time Frame: one year ]Evaluate rate of appropriate genetic counseling and/or genetic testing one year prior to using the family history collection and decision support tool and one year after
- Measure patient-related outcomes associated with using the MeTree tool [ Time Frame: Day 1 ]We assess satisfaction, comfort, anxiety, and preparedness associated with using the MeTree tool via survey immediately after completing the family history collection.
- Measure physician experience with the MeTree system [ Time Frame: 3 months ]Evaluate physicians' perceptions of satisfaction, the tool's impact on work load and its effectiveness via survey and informal interviews at 3 months.
- Implementation parameters for MeTree [ Time Frame: up to 2 years ]Part of the formative evaluation of the implementation process which includes other secondary measures as well as those related to impact on the clinic such as time to use the tool, questions asked while taking the tool, and resources and support that will be needed to implement the tool in a non-study environment
Biospecimen Retention: Samples With DNA
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): NCT01372553
|United States, North Carolina|
|Greensboro, North Carolina, United States, 27401|
|Principal Investigator:||Geoffrey S Ginsburg, MD, PhD||Duke University|