Clinical trial NCT01372553: Guilford Genomic Medicine Initiative (GGMI)
Official title: Guilford Genomic Medicine Initiative (GGMI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Ovarian Cancer
Colon Cancer
Thrombophilia
Keywords: Primary care
Family History
Risk Stratification
Cancer
Thrombosis
Lead sponsor: The Moses H. Cone Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Duke University
name: University of North Carolina, Greensboro
First posted: 2011-06-14
Enrollment: 1184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Evaluate effectiveness of family history collection and decision support for increasing appropriate referrals to genetic counselors for patients at risk of hereditary cancer syndromes
timeFrame: 1 year
measure: Evaluate effectiveness of family history collection and decision support for increasing appropriate screening for breast, colon, and ovarian cancer
timeFrame: 1 year
measure: Evaluate effectiveness of family history collection and decision support for appropriate risk-based management of thrombosis
timeFrame: one year
Secondary outcomes:
measure: Measure patient-related outcomes associated with using the MeTree tool
timeFrame: Day 1
measure: Measure physician experience with the MeTree system
timeFrame: 3 months
measure: Implementation parameters for MeTree
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
Study officials:
affiliation: Duke University
name: Geoffrey S Ginsburg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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 Semin Med Genet. 2014 Mar;166C(1):24-33. doi: 10.1002/ajmg.c.31388. Epub 2014 Mar 10.
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.
citation: 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.
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 hybrid controlled implementation-effectiveness trial. BMC Fam Pract. 2013 Aug 6;14:111. doi: 10.1186/1471-2296-14-111.