Clinical trial NCT01956773: Family Health History in Diverse Care Settings (FHH)
Official title: Family Health History in Diverse Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Heart Disease
Cancer
Keywords: family health history
prevention
genetic risk
clinical decision support
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 2620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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 criteria: 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:

* None

Primary outcomes:
measure: Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year
timeFrame: Baseline, 3 and 12 months
Secondary outcomes:
measure: Number of Participants Reporting Satisfaction When Using the MeTree Tool
timeFrame: 3 months
measure: Number of Participants Reporting Comfort When Using the MeTree Tool
timeFrame: 3 months
measure: Number of Participants Reporting Anxiety When Using the MeTree Tool
timeFrame: 3 months
measure: Number of Participants Reporting Preparedness When Using the MeTree Tool
timeFrame: 3 months
measure: Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load
timeFrame: 3 months
measure: Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow
timeFrame: 1 year
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: David Grant Medical Center
state: California
city: Duluth
country: United States
facility: Essentia Institute of Rural Health
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Duke University, Institute for Genome Science and Policy
name: Geoffrey S Ginsburg, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University, Department of Medicine
name: Lori Orlando, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orlando LA, Wu RR, Myers RA, Neuner J, McCarty C, Haller IV, Harry M, Fulda KG, Dimmock D, Rakhra-Burris T, Buchanan A, Ginsburg GS. At the intersection of precision medicine and population health: an implementation-effectiveness study of family health history based systematic risk assessment in primary care. BMC Health Serv Res. 2020 Nov 7;20(1):1015. doi: 10.1186/s12913-020-05868-1.
citation: Wu RR, Myers RA, Buchanan AH, Dimmock D, Fulda KG, Haller IV, Haga SB, Harry ML, McCarty C, Neuner J, Rakhra-Burris T, Sperber N, Voils CI, Ginsburg GS, Orlando LA. Effect of Sociodemographic Factors on Uptake of a Patient-Facing Information Technology Family Health History Risk Assessment Platform. Appl Clin Inform. 2019 Mar;10(2):180-188. doi: 10.1055/s-0039-1679926. Epub 2019 Mar 13.
citation: Wu RR, Myers RA, McCarty CA, Dimmock D, Farrell M, Cross D, Chinevere TD, Ginsburg GS, Orlando LA; Family Health History Network. Protocol for the "Implementation, adoption, and utility of family history in diverse care settings" study. Implement Sci. 2015 Nov 24;10:163. doi: 10.1186/s13012-015-0352-8.