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Guilford Genomic Medicine Initiative (GGMI) (GGMI)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01372553
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : April 16, 2014
Sponsor:
Collaborators:
Duke University
University of North Carolina, Greensboro
Information provided by (Responsible Party):
The Moses H. Cone Memorial Hospital

Study Description
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Brief Summary:
  • 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
Breast Cancer Ovarian Cancer Colon Cancer Thrombophilia

Study Design
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Study Type : Observational
Actual Enrollment : 1184 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Guilford Genomic Medicine Initiative (GGMI)
Study Start Date : October 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Total number of project participants that completed family health history tool was 1,184.. Out of the 1,184 subjects, 75 DNA saliva samples were collected.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study takes place in two Primary care practices. Patient's that come in for well-visits are invited to participate in the study.
Criteria

Inclusion Criteria:

  • All patients scheduled for an upcoming well or new visit within the next 3 weeks with their primary care physician (at the two implementation clinics).

Exclusion Criteria:

  • Non-english speaking
  • not consentable
  • adopted
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Cone Health
Greensboro, North Carolina, United States, 27401
Sponsors and Collaborators
The Moses H. Cone Memorial Hospital
Duke University
University of North Carolina, Greensboro
Investigators
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Principal Investigator: Geoffrey S Ginsburg, MD, PhD Duke University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: The Moses H. Cone Memorial Hospital
ClinicalTrials.gov Identifier: NCT01372553    
Other Study ID Numbers: W81XWH-05-1-0383
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Keywords provided by The Moses H. Cone Memorial Hospital:
Primary care
Family History
Risk Stratification
Cancer
Thrombosis
Additional relevant MeSH terms:
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Thrombophilia
Hematologic Diseases