Guilford Genomic Medicine Initiative (GGMI)

Completed

• Conditions: Breast Cancer; Colon Cancer; Thrombophilia; Ovarian Cancer

• Registration Number: NCT01372553
• Lead Sponsor: The Moses H. Cone Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-14
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-15
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1184

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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 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.

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Cone Health; 🇺🇸 Greensboro, North Carolina, United States