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

Family Health History in Diverse Care Settings

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Cancer; Heart Disease
• Intervention / Treatment: Other: MeTree

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
• Enrollment (Actual): 2620
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fairfield, California, United States, 94535
      • David Grant Medical Center
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Institute of Rural Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Science Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Satisfaction When Using the MeTree Tool	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	3 months
Number of Participants Reporting Comfort When Using the MeTree Tool	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 months
Number of Participants Reporting Anxiety When Using the MeTree Tool	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	3 months
Number of Participants Reporting Preparedness When Using the MeTree Tool	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	3 months
Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load	Evaluate physicians' perceptions of satisfaction, the MeTree tool's impact on work load and its effectiveness via survey and informal interviews at 3 months.	3 months
Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow	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)	1 year

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: 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 and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2014
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimated): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: prevention; clinical decision support; genetic risk; family health history
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: Pro00043372; Pro00047666 (Other Identifier: DUHS IRB)