N/A
N=2,620
Family Health History in Diverse Care Settings (FHH)
Diabetes · Heart Disease · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01956773 ↗Enrolled (actual)
2,620
Serious AEs
—
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year — 571; 49; 32; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MeTree (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year |
571; 49; 32; 31 | — |
| SECONDARY Number of Participants Reporting Satisfaction When Using the MeTree Tool |
69; 459; 474; 59; 23; 18 | — |
| SECONDARY Number of Participants Reporting Comfort When Using the MeTree Tool |
20; 78; 988; 16 | — |
| SECONDARY Number of Participants Reporting Anxiety When Using the MeTree Tool |
14; 1032; 43; 13 | — |
| SECONDARY Number of Participants Reporting Preparedness When Using the MeTree Tool |
59; 377; 646; 20 | — |
| SECONDARY Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load |
34; 9 | — |
| SECONDARY Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow |
100 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01956773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.