Guilford Genomic Medicine Initiative (GGMI)

Sponsor

The Moses H. Cone Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01372553

Collaborator

Duke University (Other), University of North Carolina, Greensboro (Other)

1,184

Enrollment

Location

Duration (Months)

39.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Breast Cancer Ovarian Cancer Colon Cancer Thrombophilia

Study Design

Study Type:

Observational

Actual Enrollment :

1184 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Guilford Genomic Medicine Initiative (GGMI)

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

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 [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 [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 [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

Measure patient-related outcomes associated with using the MeTree tool [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).