Guilford Genomic Medicine Initiative (GGMI) (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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 1184

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Cone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

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

Collaborators and Investigators

• Sponsor: The Moses H. Cone Memorial Hospital
• Collaborators: Duke University; University of North Carolina, Greensboro
• Investigators: Principal Investigator: Geoffrey S Ginsburg, MD, PhD, Duke University

Publications and helpful links

General Publications

• 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.
• 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.
• 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 Semin Med Genet. 2014 Mar;166C(1):24-33. doi: 10.1002/ajmg.c.31388. Epub 2014 Mar 10.
• 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.
• 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/s10689-014-9701-z.
• 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 hybrid controlled implementation-effectiveness trial. BMC Fam Pract. 2013 Aug 6;14:111. doi: 10.1186/1471-2296-14-111.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): April 16, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Cancer; Primary care; Thrombosis; Risk Stratification; Family History
• Additional Relevant MeSH Terms: Hematologic Diseases; Thrombophilia
• Other Study ID Numbers: W81XWH-05-1-0383