Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Jennifer S. Haas, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01468675
First received: November 4, 2011
Last updated: March 4, 2014
Last verified: March 2014

November 4, 2011
March 4, 2014
February 2013
December 2014   (final data collection date for primary outcome measure)
documentation of family history in coded fields in the patient's electronic health record [ Time Frame: 3 months following primary care visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01468675 on ClinicalTrials.gov Archive Site
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Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care
Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care

Growing evidence and understanding of an inherited component to several common, chronic diseases has led to an increase in the importance of information about family health history, and the integration of this information with other risk factors for common diseases, like lifestyle risk factors. The US Preventive Services Task Force (USPSTF) recommends the use of family health history as a routine genetic screening test for common diseases, as obtaining a complete family health history is the first step to identifying patients who are in need of intervention (e.g., intensive screening, lifestyle modification, preventative therapies, genetic counseling). The importance of integrating family health history with an individual's medical record will increase as our understanding of the genome evolves because it will be more essential to put detailed personal genetic information into a clinical context. Because of limited time during a typical primary care visit, and the concerns of primary care providers (PCPs) about their self-efficacy of estimating and providing guidance about risk, PCPs frequently do not obtain a family health history or provide individualized risk assessment. These issues highlight the need to leverage technology to collect these data independent of clinic visits, yet have these data interoperate with an individual's electronic health record (EHR). Telephonic interactive voice response systems (IVRS) and self-administered web-based tools are a low-cost, sustainable way of reaching out to primary care populations, independent of a visit. We propose to develop, implement, and evaluate a patient-reported, EHR-integrated personalized risk assessment module to provide tailored disease risk and risk reduction information.

The Specific Aims of the proposed project are to: Aim 1: Develop a patient-reported, EHR-integrated, personalized risk assessment module to provide tailored disease risk and risk reduction information for four common diseases (breast cancer, colorectal cancer, coronary heart disease, and type II diabetes) for the patient and his/ her PCP. Aim 2: Measure the reach and effectiveness of this integrated risk assessment module by conducting a cluster randomized controlled trial (RCT) of adult primary care patients in the Brigham and Women's Primary Care Practice-Based Research Network. Aim 3: Evaluate facilitators and barriers to the adoption and implementation of this integrated risk assessment module.

This project will further our understanding of how technology can be used to fill a gap in current clinical practice by facilitating the systematic collection of family health history and lifestyle risk factor data and integrating these data with an individual's EHR to personalize care in a variety of settings and for diverse patient populations. This work will use current national data standards for interoperability, and lessons learned from this project will be exportable to healthcare settings throughout the United States.

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Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Colorectal Cancer
  • Breast Cancer
  • Coronary Heart Disease
  • Diabetes
Other: risk assessment survey; decision support for providers for prevention based on risk
  • Experimental: risk assessment and prevention recomendations
    Validated, web-based risk assessment is being used to assess personalized risk and generate a risk report
    Intervention: Other: risk assessment survey; decision support for providers for prevention based on risk
  • No Intervention: control
    Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16000
March 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults 18 - 75 Years old
  • English or Spanish speaking
  • Recent visit to a participating primary care practice
Both
18 Years to 75 Years
No
Contact: Jennifer Haas, MD 617-732-7063 jhaas@partners.org
United States
 
NCT01468675
2009P002762
No
Jennifer S. Haas, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Jennifer Haas, MD Brigham and Women's Hospital
Brigham and Women's Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP