Family Health History in Diverse Care Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01956773
Recruitment Status : Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Diabetes Heart Disease Cancer Other: MeTree Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Family Health History in Diverse Care Settings
Actual Study Start Date : April 11, 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Active Comparator: MeTree
MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients and providers as clinical decision support.
Other: MeTree
Software program collecting family health history and generating clinical decision support for risk-based preventive care

No Intervention: Control
to compare rates of risk management strategies in standard care during the time of MeTree use in the intervention arm.

Primary Outcome Measures :
  1. Increasing uptake of risk-management evidence based preventive strategies for the clinical decision support conditions [ Time Frame: Baseline, 3 and 12 months ]
    How many patients identified to be at increased risk for the clinical decision support conditions, how many providers order the recommended prevention strategy, and how many patients adhere to the provider recommendation.

Secondary Outcome Measures :
  1. Measure patient-related outcomes associated with using the MeTree tool [ Time Frame: 3 months and 12 months ]
    The study will assess satisfaction, comfort, anxiety, and preparedness associated with using the MeTree tool via survey 3 and 12 months after completing the family history collection.

  2. Measure physician experience with MeTree [ Time Frame: 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. Implementation parameters for MeTree [ Time Frame: up to 3 years ]
    Formative evaluation of the implementation process which includes barriers and solutions to implementing MeTree into clinical practice setting.

  4. uptake of MeTree by clinical practices [ Time Frame: 1 year ]
    Evaluate which clinics/providers are successfully using MeTree in their clinical work flow and which patients are successfully using MeTree for their care. (surveys, monitoring of clinical workflow, patient recruitment reflects underlying clinic population)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01956773

United States, California
David Grant Medical Center
Fairfield, California, United States, 94535
United States, Minnesota
Essentia Institute of Rural Health
Duluth, Minnesota, United States, 55805
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Duke University
Principal Investigator: Geoffrey S Ginsburg, MD PHD Duke University, Institute for Genome Science and Policy
Principal Investigator: Lori Orlando, MD Duke University, Department of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT01956773     History of Changes
Other Study ID Numbers: Pro00043372
Pro00047666 ( Other Identifier: DUHS IRB )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Duke University:
family health history
genetic risk
clinical decision support

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases