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Guilford Genomic Medicine Initiative (GGMI)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Duke University
University of North Carolina, Greensboro
Information provided by:
The Moses H. Cone Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01372553
First received: June 9, 2011
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose
  • 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 Phase
Breast Cancer
Ovarian Cancer
Colon Cancer
Thrombophilia
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Guilford Genomic Medicine Initiative (GGMI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Moses H. Cone Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Measure patient-related outcomes associated with using the MeTree tool [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Saliva


Enrollment: 24
Study Start Date: April 2005
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Primary Care, Family Health History, Genetic Counseling,
Primary Care, Family Health History

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372553

Locations
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
Principal Investigator: Geoffrey S Ginsburg, MD, PhD Duke University
  More Information

No publications provided

Responsible Party: Dr. Geoffrey Ginsburg, Duke University
ClinicalTrials.gov Identifier: NCT01372553     History of Changes
Other Study ID Numbers: W81XWH-05-1-0383
Study First Received: June 9, 2011
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Moses H. Cone Memorial Hospital:
Population invited are patient's at Primary care practices that come in for the well visits only

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Ovarian Neoplasms
Thrombophilia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013