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Guilford Genomic Medicine Initiative (GGMI) (GGMI)

15. april 2014 opdateret af: The Moses H. Cone Memorial Hospital
  • 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1184

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Cone Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate effectiveness of family history collection and decision support for increasing appropriate referrals to genetic counselors for patients at risk of hereditary cancer syndromes
Tidsramme: 1 year
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
Tidsramme: 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
1 year
Evaluate effectiveness of family history collection and decision support for appropriate risk-based management of thrombosis
Tidsramme: 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
one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measure patient-related outcomes associated with using the MeTree tool
Tidsramme: Day 1
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
Tidsramme: 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 months
Implementation parameters for MeTree
Tidsramme: 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
up to 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Moses H. Cone Memorial Hospital

Samarbejdspartnere

Duke University
University of North Carolina, Greensboro

Efterforskere

  • Ledende efterforsker: Geoffrey S Ginsburg, MD, PhD, Duke University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

1. april 2012

Datoer for studieregistrering

Først indsendt

9. juni 2011

Først indsendt, der opfyldte QC-kriterier

10. juni 2011

Først opslået (Skøn)

14. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • W81XWH-05-1-0383

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner