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
  Purpose

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.


Condition Intervention
Colorectal Cancer
Breast Cancer
Coronary Heart Disease
Diabetes
Other: risk assessment survey; decision support for providers for prevention based on risk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16000
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: risk assessment and prevention recomendations
Validated, web-based risk assessment is being used to assess personalized risk and generate a risk report
Other: risk assessment survey; decision support for providers for prevention based on risk
No Intervention: control
Usual care

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 - 75 Years old
  • English or Spanish speaking
  • Recent visit to a participating primary care practice
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468675

Contacts
Contact: Jennifer Haas, MD 617-732-7063 jhaas@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02120
Contact: Jenifer Haas, MD    617-732-7063    jhaas@partners.org   
Principal Investigator: Jennifer Haas, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jennifer Haas, MD Brigham and Women's Hospital
  More Information

No publications provided

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
Study First Received: November 4, 2011
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014