Family Health History in Diverse Care Settings

Status:	Active, not recruiting
Conditions:	Cancer, Cancer, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/30/2018
Start Date:	April 11, 2014
End Date:	April 2019

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.

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.

Inclusion Criteria:

- Adults 18 years of age

- Scheduled for a well visit appointment in selected clinics

- English and Spanish speaking

- Able to provide informed consent

Exclusion Criteria:

We found this trial at

sites

David Grant Medical Center

Fairfield, California 94535

Principal Investigator: Carlos Maldonado, PhD

from

Fairfield, CA