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Family Health History in Diverse Care Settings (FHH) (FHH)

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.
 
ClinicalTrials.gov Identifier: NCT01956773
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : October 8, 2019
Last Update Posted : November 25, 2019
Sponsor:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2620 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

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

Experimental: MeTree - Provider
MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support.
Other: MeTree
Software program collecting family health history and generating clinical decision support for risk-based preventive care




Primary Outcome Measures :
  1. Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year [ Time Frame: Baseline, 3 and 12 months ]
    How many patients identified as meeting criteria for genetic counseling, how many providers ordered genetic counseling, and how many patients adhere to the provider recommendation at 1 year.


Secondary Outcome Measures :
  1. Number of Participants Reporting Satisfaction When Using the MeTree Tool [ Time Frame: 3 months ]
    The study will assess satisfaction associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked their level of satisfaction with their experience using the web-based portal to enter information for their provider before their appointment

  2. Number of Participants Reporting Comfort When Using the MeTree Tool [ Time Frame: 3 months ]
    The study will assess comfort associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked if the MeTree program was easy to use

  3. Number of Participants Reporting Anxiety When Using the MeTree Tool [ Time Frame: 3 months ]
    The study will assess anxiety associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked if answering the questions made them anxious

  4. Number of Participants Reporting Preparedness When Using the MeTree Tool [ Time Frame: 3 months ]
    The study will assess preparedness associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participants were asked if they had enough information about some people in their family when completing MeTree

  5. Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load [ Time Frame: 3 months ]
    Evaluate physicians' perceptions of satisfaction, the MeTree tool's impact on work load and its effectiveness via survey and informal interviews at 3 months.

  6. Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow [ Time Frame: 1 year ]
    Evaluate which providers were 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)



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

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 ClinicalTrials.gov identifier (NCT number): NCT01956773


Locations
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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
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Duke University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01956773    
Other Study ID Numbers: Pro00043372
Pro00047666 ( Other Identifier: DUHS IRB )
First Posted: October 8, 2013    Key Record Dates
Results First Posted: October 8, 2019
Last Update Posted: November 25, 2019
Last Verified: November 2019
Keywords provided by Duke University:
family health history
prevention
genetic risk
clinical decision support
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases