Family Health History in Diverse Care Settings (FHH)

Not Applicable

Completed

• Conditions: Heart Disease; Diabetes; Cancer
• Interventions: Other: MeTree

• Registration Number: NCT01956773
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Study Start: 2014-04-11
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Results First Submitted: 2019-02-18
• Results First Submitted QC: 2019-09-16
• Results First Posted: 2019-10-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2620

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MeTree - Patient	MeTree	MeTree 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	MeTree	MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year	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

Name	Time	Method
Number of Participants Reporting Satisfaction When Using the MeTree Tool	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
Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load	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.
Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow	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)
Number of Participants Reporting Comfort When Using the MeTree Tool	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
Number of Participants Reporting Anxiety When Using the MeTree Tool	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
Number of Participants Reporting Preparedness When Using the MeTree Tool	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

Trial Locations

Locations (5)

David Grant Medical Center; 🇺🇸 Fairfield, California, United States

Essentia Institute of Rural Health; 🇺🇸 Duluth, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of North Texas Health Science Center; 🇺🇸 Fort Worth, Texas, United States