Guilford Genomic Medicine Initiative (GGMI)

Study Overview
=================
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.

Official Title
-----------------
Guilford Genomic Medicine Initiative (GGMI)

Conditions
-----------------
Thrombophilia, Ovarian Cancer, Breast Cancer, Colon Cancer

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family history risk stratification<br>primary care patients who receive risk stratification and clinical decision support based upon the family health history they entered in to MeTree | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate effectiveness of family history collection and decision support for increasing appropriate referrals to genetic counselors for patients at risk of hereditary cancer syndromes | change in appropriate referal to genetic counseling one year before using MeTree compared to one year after. | 1 year | 
| Evaluate effectiveness of family history collection and decision support for increasing appropriate screening for breast, colon, and ovarian cancer | 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 | 1 year | 
| Evaluate effectiveness of family history collection and decision support for appropriate risk-based management of thrombosis | 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 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure patient-related outcomes associated with using the MeTree tool | We assess satisfaction, comfort, anxiety, and preparedness associated with using the MeTree tool via survey immediately after completing the family history collection. | Day 1 | 
| Measure physician experience with the MeTree system | Evaluate physicians' perceptions of satisfaction, the tool's impact on work load and its effectiveness via survey and informal interviews at 3 months. | 3 months | 
| Implementation parameters for MeTree | 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 | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary care, Family History, Risk Stratification, Cancer, Thrombosis