Guilford Genomic Medicine Initiative (GGMI)

This study has been completed.
Sponsor:
Collaborators:
Duke University
University of North Carolina, Greensboro
Information provided by (Responsible Party):
The Moses H. Cone Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01372553
First received: June 9, 2011
Last updated: April 15, 2014
Last verified: April 2014

June 9, 2011
April 15, 2014
October 2009
April 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01372553 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Guilford Genomic Medicine Initiative (GGMI)
Guilford Genomic Medicine Initiative (GGMI)
  • 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.
Not Provided
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

The study takes place in two Primary care practices. Patient's that come in for well-visits are invited to participate in the study.

  • Breast Cancer
  • Ovarian Cancer
  • Colon Cancer
  • Thrombophilia
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1184
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01372553
W81XWH-05-1-0383
No
The Moses H. Cone Memorial Hospital
The Moses H. Cone Memorial Hospital
  • Duke University
  • University of North Carolina, Greensboro
Principal Investigator: Geoffrey S Ginsburg, MD, PhD Duke University
The Moses H. Cone Memorial Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP