Family Health History in Diverse Care Settings (FHH)

Cancer Clinical Trial

— FHH  

Official title:

Family Health History in Diverse Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956773
• Other study ID #: Pro00043372
• Secondary ID: Pro00047666
• Status: Completed
• Phase: N/A
• Start date: April 11, 2014
• Est. completion date: October 31, 2017

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2620
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Diabetes
• Heart Disease
• Heart Diseases

Intervention

Other:
• MeTree
Software program collecting family health history and generating clinical decision support for risk-based preventive care

Locations

Country	Name	City	State
United States	Essentia Institute of Rural Health	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	David Grant Medical Center	Fairfield	California
United States	University of North Texas Health Science Center	Fort Worth	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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