We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468675
First Posted: November 9, 2011
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer S. Haas, MD, Brigham and Women's Hospital
  Purpose
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.

Condition Intervention
Colorectal Cancer Breast Cancer Coronary Heart Disease Diabetes Other: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care

Resource links provided by NLM:


Further study details as provided by Jennifer S. Haas, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Number of Subjects Who Discussed Disease Risk With Primary Care Provider [ Time Frame: 3 months following primary care visit ]

Enrollment: 6075
Study Start Date: February 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The intervention is completion of a validated, web-based risk assessment used to assess personalized risk and generate a risk report
Other: Intervention
risk assessment survey; decision support for providers for prevention based on risk
Other Name: Risk Assessment and Prevention Recommendations
No Intervention: Control
Usual Care

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468675


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jennifer Haas, MD Brigham and Women's Hospital
  More Information

Responsible Party: Jennifer S. Haas, MD, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01468675     History of Changes
Other Study ID Numbers: 2009P002762
First Submitted: November 4, 2011
First Posted: November 9, 2011
Results First Submitted: December 21, 2016
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases