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Spots Global Cancer Trial Database for Family Health History in Diverse Care Settings (FHH)

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Trial Identification

Brief Title: Family Health History in Diverse Care Settings (FHH)

Official Title: Family Health History in Diverse Care Settings

Study ID: NCT01956773

Interventions

MeTree

Study Description

Brief Summary: 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. The investigators 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. The study team 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.

Detailed Description: Five health care delivery organizations will participate in this demonstration project: Duke University, the Medical College of Wisconsin, the Air Force, Essentia Health, and the University of North Texas Health Science Center. The study will take place in 'real world' clinical, socio-cultural, and demographically diverse (rural, underserved, academic, family medicine) care clinics (n=34) in 5 states (CA, MN, NC, WI, TX) that include genomic medicine 'early adopter' and 'naïve' sites, as well as those that are EMR-enabled and others that are not. The study team will recruit a minimum of 7000 English or Spanish speaking adults over a 3-year period and will capture process metrics and outcomes that are measured in the course of usual care. The 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

David Grant Medical Center, Fairfield, California, United States

Essentia Institute of Rural Health, Duluth, Minnesota, United States

Duke University Medical Center, Durham, North Carolina, United States

University of North Texas Health Science Center, Fort Worth, Texas, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Contact Details

Name: Geoffrey S Ginsburg, MD PHD

Affiliation: Duke University, Institute for Genome Science and Policy

Role: PRINCIPAL_INVESTIGATOR

Name: Lori Orlando, MD

Affiliation: Duke University, Department of Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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