Guilford Genomic Medicine Initiative (GGMI)

Breast Cancer Clinical Trial

— GGMI  

Official title:

Guilford Genomic Medicine Initiative (GGMI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372553
• Other study ID #: W81XWH-05-1-0383
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2011
• Last updated: April 15, 2014
• Start date: October 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: The Moses H. Cone Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1184
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Ovarian Cancer
• Thrombophilia

Locations

Country	Name	City	State
United States	Cone Health	Greensboro	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
The Moses H. Cone Memorial Hospital	Duke University, University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

References & Publications (6)

Beadles CA, Ryanne Wu R, Himmel T, Buchanan AH, Powell KP, Hauser E, Henrich VC, Ginsburg GS, Orlando LA. Providing patient education: impact on quantity and quality of family health history collection. Fam Cancer. 2014 Jun;13(2):325-32. doi: 10.1007/s106 — View Citation

Orlando LA, Buchanan AH, Hahn SE, Christianson CA, Powell KP, Skinner CS, Chesnut B, Blach C, Due B, Ginsburg GS, Henrich VC. Development and validation of a primary care-based family health history and decision support program (MeTree). N C Med J. 2013 Jul-Aug;74(4):287-96. — View Citation

Orlando LA, Hauser ER, Christianson C, Powell KP, Buchanan AH, Chesnut B, Agbaje AB, Henrich VC, Ginsburg G. Protocol for implementation of family health history collection and decision support into primary care using a computerized family health history system. BMC Health Serv Res. 2011 Oct 11;11:264. doi: 10.1186/1472-6963-11-264. — View Citation

Orlando LA, Wu RR, Beadles C, Himmel T, Buchanan AH, Powell KP, Hauser ER, Henrich VC, Ginsburg GS. Implementing family health history risk stratification in primary care: impact of guideline criteria on populations and resource demand. Am J Med Genet C S — View Citation

Wu RR, Himmel TL, Buchanan AH, Powell KP, Hauser ER, Ginsburg GS, Henrich VC, Orlando LA. Quality of family history collection with use of a patient facing family history assessment tool. BMC Fam Pract. 2014 Feb 13;15:31. doi: 10.1186/1471-2296-15-31. — View Citation

Wu RR, Orlando LA, Himmel TL, Buchanan AH, Powell KP, Hauser ER, Agbaje AB, Henrich VC, Ginsburg GS. Patient and primary care provider experience using a family health history collection, risk stratification, and clinical decision support tool: a type 2 h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No