NCT01372553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,184

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

2.5 years

First QC Date

June 9, 2011

Last Update Submit

April 15, 2014

Conditions

Breast CancerOvarian CancerColon CancerThrombophilia

Keywords

Primary careFamily HistoryRisk StratificationCancerThrombosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Measure patient-related outcomes associated with using the MeTree tool

    Day 1

  • Measure physician experience with the MeTree system

    3 months

  • Implementation parameters for MeTree

    up to 2 years

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • Non-english speaking
  • not consentable
  • adopted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cone Health

Greensboro, North Carolina, 27401, United States

Location

Related Publications (6)

  • 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.

    PMID: 24044145BACKGROUND

  • 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.

    PMID: 21989281BACKGROUND

  • 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.

    PMID: 24616329RESULT

  • 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.

    PMID: 24520818RESULT

  • 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.

    PMID: 24515581RESULT

  • 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.

    PMID: 23915256RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Total number of project participants that completed family health history tool was 1,184.. Out of the 1,184 subjects, 75 DNA saliva samples were collected.

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsColonic NeoplasmsThrombophiliaNeoplasmsThrombosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Geoffrey S Ginsburg, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 14, 2011

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations

US(1)