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

NCT ID: NCT01468675

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6075 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-12-31

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.

Conditions

Colorectal Cancer; Breast Cancer; Coronary Heart Disease; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Intervention

Intervention Type: OTHER

risk assessment survey; decision support for providers for prevention based on risk

Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention

risk assessment survey; decision support for providers for prevention based on risk

Intervention Type: OTHER

Other Intervention Names

Risk Assessment and Prevention Recommendations

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer S. Haas, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009P002762

Identifier Type: -

Identifier Source: org_study_id