Family Health History in Diverse Care Settings

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01956773
First received: September 30, 2013
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Diabetes
Heart Disease
Cancer
Other: MeTree

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Family Health History in Diverse Care Settings

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Increasing uptake of risk-management evidence based preventive strategies for the clinical decision support conditions [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    How many patients identified to be at increased risk for the clinical decision support conditions, how many providers order the recommended prevention strategy, and how many patients adhere to the provider recommendation.


Secondary Outcome Measures:
  • Measure patient-related outcomes associated with using the MeTree tool [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]
    The study will assess satisfaction, comfort, anxiety, and preparedness associated with using the MeTree tool via survey 3 and 12 months after completing the family history collection.

  • Measure physician experience with MeTree [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate physicians' perceptions of satisfaction, the tool's impact on work load and its effectiveness via survey and informal interviews at 3 months.

  • Implementation parameters for MeTree [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Formative evaluation of the implementation process which includes barriers and solutions to implementing MeTree into clinical practice setting.

  • uptake of MeTree by clinical practices [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluate which clinics/providers are 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)


Estimated Enrollment: 7000
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MeTree
MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients and providers as clinical decision support.
Other: MeTree
Software program collecting family health history and generating clinical decision support for risk-based preventive care
No Intervention: Control
to compare rates of risk management strategies in standard care during the time of MeTree use in the intervention arm.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956773

Contacts
Contact: Dana Baker, MS (919) 681-9436 dana.baker@duke.edu

Locations
United States, California
David Grant Medical Center Not yet recruiting
Fairfield, California, United States, 94535
Contact: Jessica Denigro       jessica.denigro.1@us.af.mil   
Contact: Eduardo Sevillia       eduardo.sevilla.ctr@us.af.mil   
Principal Investigator: Carlos Maldonado, PhD         
United States, Minnesota
Essentia Institute of Rural Health Recruiting
Duluth, Minnesota, United States, 55805
Contact: Laurie Hall       Laurie.Hall@EssentiaHealth.org   
Contact: Joe Bianco, MD       Joseph.Bianco@EssentiaHealth.org   
Principal Investigator: Catherine McCarty, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Dana Baker, MS    919-668-2341    dana.baker@duke.edu   
Contact: Barb Walukas, BSN    919 419-5920    barb.walukas@duke.edu   
Principal Investigator: Geoffrey Ginsburg, MD PhD         
Sub-Investigator: Lori Orlando, MD MHS         
United States, Texas
University of North Texas Health Science Center Not yet recruiting
Fort Worth, Texas, United States, 76107
Contact: Deanna S Cross, PhD       Deanna.Cross@unthsc.edu   
Principal Investigator: Deanna Cross, PhD         
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jennifer Geurts       jgeurts@mcw.edu   
Principal Investigator: Michael Farrell, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01956773     History of Changes
Other Study ID Numbers: Pro00043372, Pro00047666
Study First Received: September 30, 2013
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Duke University:
family health history
prevention
genetic risk
clinical decision support

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014