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Grant Details

Grant Number: 4U01HG007282-04 Interpret this number
Primary Investigator: Ginsburg, Geoffrey
Organization: Duke University
Project Title: Implementation, Adoption, and Utility of Family History in Diverse Care Settings
Fiscal Year: 2016
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Abstract

DESCRIPTION (provided by applicant): The outcome of this research will be a demonstration that family health history (FHH) risk data can be used efficiently to deliver more effective healthcare in geographically and ethnically diverse clinical care environments. Although FHH is a standard component of the medical interview its widespread adoption is hindered by three major barriers: (1) a dearth of standard collection methods; (2) the absence of health care provider access to complete FHH information; and (3) the need for clinical guidance for the interpretation and use of FHH. In addition, the time constraints of the busy provider and poor integration of FHH with paper medical records or electronic medical records (EMR) impede its widespread use. We hypothesize that patient- driven and electronic collection of FHH for risk stratification will promote more informed decision-making by patients and providers, and improves adherence to risk-stratified preventive care guidelines. We will use an implementation sciences approach to integrate an innovative FHH system that collects FHH from patients. Intermountain Healthcare will provide the information technology expertise with EMR design to develop an innovative solution to a storage model standard for FHH data as well as a centralized standards-compliant open clinical decision support (OpenCDS) rule development architecture to analyze FHH and to generate evidence-based, individualized, disease risk, preventive care recommendations for both patients and providers. Five health care delivery organizations will participate in this demonstration project: Duke University, the Medical College of Wisconsin, the Air Force, Essential Health, and the Marshfield Clinic. The study will take place in 'real world' clinical, socio-cultural, and demographically diverse (rural, underserved, academic, family medicine) care clinics (n=34) in 6 states (CA, ID, MN, NC, ND, WI) that include genomic medicine 'early adopter' and 'nave' sites, as well as those that are EMR-enabled and others that are not. Using a cluster randomized controlled pragmatic hybrid type III implementation-effectiveness observational study design, we hypothesize we can demonstrate uptake of the Genomic Medicine Model and its clinical and personal utility. We will recruit a minimum of 7000 English or Spanish speaking adults over a 3-year period and we will capture process metrics and outcomes that are measured in the course of usual care. Our goals are: 1)To optimize the collection of patient entered FHH in diverse clinical environments for coronary heart disease, thrombosis, and selected cancers, 2) to export FHH data to an OpenCDS platform and return CDS results to providers and patients (and to EMRs where relevant) and to explore the integration of genetic risk and FHH data at selected sites, 3) to assess the clinical and personal utility of FHH using a pragmatic observational study design to assess reach, adoption, integrity, exposure, and sustainability, and to capture, analyze, and report effectiveness outcomes at each stakeholder level: patient, provider, and clinic/system, and 4) to take a leadership role in the dissemination of guidelines for FHH intervention across in diverse practice settings.

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Publications

Implementation, adoption, and utility of family health history risk assessment in diverse care settings: evaluating implementation processes and impact with an implementation framework.
Authors: Wu R.R. , Myers R.A. , Sperber N. , Voils C.I. , Neuner J. , McCarty C.A. , Haller I.V. , Harry M. , Fulda K.G. , Cross D. , et al. .
Source: Genetics In Medicine : Official Journal Of The American College Of Medical Genetics, 2018-06-06 00:00:00.0; , .
EPub date: 2018-06-06 00:00:00.0.
PMID: 29875427
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Research directions in the clinical implementation of pharmacogenomics - An Overview of US programs and projects.
Authors: Volpi S. , Bult C. , Chisholm R.L. , Deverka P.A. , Ginsburg G.S. , Jacob H.J. , Kasapi M. , McLeod H.L. , Roden D.M. , Williams M.S. , et al. .
Source: Clinical Pharmacology And Therapeutics, 2018-02-20 00:00:00.0; , .
EPub date: 2018-02-20 00:00:00.0.
PMID: 29460415
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Developing a common framework for evaluating the implementation of genomic medicine interventions in clinical care: the IGNITE Network's Common Measures Working Group.
Authors: Orlando L.A. , Sperber N.R. , Voils C. , Nichols M. , Myers R.A. , Wu R.R. , Rakhra-Burris T. , Levy K.D. , Levy M. , Pollin T.I. , et al. .
Source: Genetics In Medicine : Official Journal Of The American College Of Medical Genetics, 2017-09-14 00:00:00.0; , .
EPub date: 2017-09-14 00:00:00.0.
PMID: 28914267
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Challenges and strategies for implementing genomic services in diverse settings: experiences from the Implementing GeNomics In pracTicE (IGNITE) network.
Authors: Sperber N.R. , Carpenter J.S. , Cavallari L.H. , J Damschroder L. , Cooper-DeHoff R.M. , Denny J.C. , Ginsburg G.S. , Guan Y. , Horowitz C.R. , Levy K.D. , et al. .
Source: Bmc Medical Genomics, 2017-05-22 00:00:00.0; 10(1), p. 35.
EPub date: 2017-05-22 00:00:00.0.
PMID: 28532511
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The IGNITE network: a model for genomic medicine implementation and research.
Authors: Weitzel K.W. , Alexander M. , Bernhardt B.A. , Calman N. , Carey D.J. , Cavallari L.H. , Field J.R. , Hauser D. , Junkins H.A. , Levin P.A. , et al. .
Source: Bmc Medical Genomics, 2016-01-05 00:00:00.0; 9, p. 1.
EPub date: 2016-01-05 00:00:00.0.
PMID: 26729011
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Protocol for the "Implementation, adoption, and utility of family history in diverse care settings" study.
Authors: Wu R.R. , Myers R.A. , McCarty C.A. , Dimmock D. , Farrell M. , Cross D. , Chinevere T.D. , Ginsburg G.S. , Orlando L.A. , Family Health History Network .
Source: Implementation Science : Is, 2015-11-24 00:00:00.0; 10, p. 163.
EPub date: 2015-11-24 00:00:00.0.
PMID: 26597091
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Development and validation of a primary care-based family health history and decision support program (MeTree).
Authors: Orlando L.A. , Buchanan A.H. , Hahn S.E. , Christianson C.A. , Powell K.P. , Skinner C.S. , Chesnut B. , Blach C. , Due B. , Ginsburg G.S. , et al. .
Source: North Carolina Medical Journal, 2013 Jul-Aug; 74(4), p. 287-96.
PMID: 24044145
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