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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Diabetes; Breast Cancer; Coronary Heart Disease
• Interventions: Other: Intervention

• Registration Number: NCT01468675
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

We evaluated whether collection of risk factors to generate an electronic health record (EHR)-linked personalized health risk appraisal (HRA) for coronary heart disease (CHD), diabetes, breast and colorectal cancer (CRC) was associated with improved patient-provider communication, risk assessment, and breast cancer screening plans in the next year.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-09
• Study Start: 2013-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-12-21
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Results First Posted: 2017-04-28
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6075

Inclusion Criteria

• Adults 18 - 75 Years old
• English or Spanish speaking
• Recent visit to a participating primary care practice

Exclusion Criteria

• No phone number or email address listed in the EHR

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	The intervention is completion of a validated, web-based risk assessment used to assess personalized risk and generate a risk report

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Discussed Disease Risk With Primary Care Provider	3 months following primary care visit

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States