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Completed

NCT Number: NCT01372553

Guilford Genomic Medicine Initiative (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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Cardiovascular Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thrombophilia Thrombosis Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cone Health

Greensboro, North Carolina, 27401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluate effectiveness of family history collection and decision support for increasing appropriate referrals to genetic counselors for patients at risk of hereditary cancer syndromes

    Time frame: 1 year

    change in appropriate referal to genetic counseling one year before using MeTree compared to one year after.

  2. Evaluate effectiveness of family history collection and decision support for increasing appropriate screening for breast, colon, and ovarian cancer

    Time frame: 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

  3. Evaluate effectiveness of family history collection and decision support for appropriate risk-based management of thrombosis

    Time frame: 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

Secondary outcomes

  1. Measure patient-related outcomes associated with using the MeTree tool

    Time frame: Day 1

    We assess satisfaction, comfort, anxiety, and preparedness associated with using the MeTree tool via survey immediately after completing the family history collection.

  2. Measure physician experience with the MeTree system

    Time frame: 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.

  3. Implementation parameters for MeTree

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Moses H. Cone Memorial Hospital

Other

Collaborators

  • Duke University
  • University of North Carolina, Greensboro

Registry information

Acronym: GGMI

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2011
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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