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

Primary Purpose

Colorectal Cancer, Breast Cancer, Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Usual Care

Outcomes

Primary Outcome Measures

Number of Subjects Who Discussed Disease Risk With Primary Care Provider

Secondary Outcome Measures

Full Information

First Posted
November 4, 2011
Last Updated
March 20, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01468675
Brief Title
Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care
Official Title
Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Breast Cancer, Coronary Heart Disease, Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6075 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention is completion of a validated, web-based risk assessment used to assess personalized risk and generate a risk report
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Intervention
Other Intervention Name(s)
Risk Assessment and Prevention Recommendations
Intervention Description
risk assessment survey; decision support for providers for prevention based on risk
Primary Outcome Measure Information:
Title
Number of Subjects Who Discussed Disease Risk With Primary Care Provider
Time Frame
3 months following primary care visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Haas, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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