Family Health History in Diverse Care Settings (FHH)
FHH
2 other identifiers
interventional
2,620
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Apr 2014
Longer than P75 for not_applicable diabetes
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedStudy Start
First participant enrolled
April 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedResults Posted
Study results publicly available
October 8, 2019
CompletedAugust 2, 2023
July 1, 2023
3.6 years
September 30, 2013
February 18, 2019
July 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year
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.
Baseline, 3 and 12 months
Secondary Outcomes (6)
Number of Participants Reporting Satisfaction When Using the MeTree Tool
3 months
Number of Participants Reporting Comfort When Using the MeTree Tool
3 months
Number of Participants Reporting Anxiety When Using the MeTree Tool
3 months
Number of Participants Reporting Preparedness When Using the MeTree Tool
3 months
Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load
3 months
- +1 more secondary outcomes
Study Arms (2)
MeTree - Patient
EXPERIMENTALMeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients as clinical decision support.
MeTree - Provider
EXPERIMENTALMeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support.
Interventions
Software program collecting family health history and generating clinical decision support for risk-based preventive care
Eligibility Criteria
You may qualify if:
- Adults 18 years of age
- Scheduled for a well visit appointment in selected clinics
- English and Spanish speaking
- Able to provide informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (5)
David Grant Medical Center
Fairfield, California, 94535, United States
Essentia Institute of Rural Health
Duluth, Minnesota, 55805, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (4)
Wu RR, Myers RA, Neuner J, McCarty C, Haller IV, Harry M, Fulda KG, Dimmock D, Rakhra-Burris T, Buchanan A, Ginsburg GS, Orlando LA. Implementation-effectiveness trial of systematic family health history based risk assessment and impact on clinical disease prevention and surveillance activities. BMC Health Serv Res. 2022 Dec 6;22(1):1486. doi: 10.1186/s12913-022-08879-2.
PMID: 36474257DERIVEDOrlando 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.
PMID: 33160339DERIVEDWu 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.
PMID: 30866001DERIVEDWu 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.
PMID: 26597091DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
12 mo survey ended early w/ approved by Duke IRB. Sufficient data obtained to perform the scientific analysis; the overall status of the study is still active, not recruiting. Participant contact completed.
Results Point of Contact
- Title
- Dr. Lori A. Orlando, Director Program in Precision Medicine
- Organization
- Duke University Medical Center
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2013
First Posted
October 8, 2013
Study Start
April 11, 2014
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
August 2, 2023
Results First Posted
October 8, 2019
Record last verified: 2023-07