Integrating Patient Generated Family Health History From Varied Electronic Health Record (EHR) Entry Portals
Condition: Family Characteristics; Health Status; Family Research
Study type: Interventional

Summary: 
      In the 21st century, the importance of family health history will increase as it will be
      essential to put detailed personal genetic information into the context of an individual's
      health, namely the context of how the shared code has played out in an individual and his/her
      closest relatives. These scientific developments in the investigators' understanding of
      genetics will demand a more comprehensive family history dataset for all patients, and the
      time limitations on healthcare providers demand a technology-driven solution that integrates
      an individual's knowledge of their family history with the medical records maintained by
      their health care providers. A solution does not currently exist by which most Americans can
      organize their family health history and then place it into their electronic health record
      (EHR). The investigators propose to develop and compare three different ways of proactively
      collecting family history information from patients using computer technology independent of
      a health care visit, including telephone (interactive voice response technology), tablet
      computers in a physician's waiting room, and a secure internet portal at home. These tools
      will be based on the US Surgeon General's My Family Health Portrait, an electronic family
      history collection tool. Family history data will be transferred and integrated with a
      patient's EHR in a large primary care network. This project will seek to demonstrate that
      family history data can be accurately reported by diverse patients using these technologies,
      and that these data can be integrated to tailor an individual's health care based on their
      familial risk.
    

Detailed description: 
      Background: The long established wisdom of including family health history as a key part of
      an individual's medical record has been invigorated by the new emphasis on personalized
      medicine. While in the past, family health history was used to understand an individual's
      disease risk and to focus disease prevention efforts, in 21st century medicine, family health
      history's importance will increase as it will be essential to put detailed personal genetic
      information into a clinical context, namely the context of how the shared code has played out
      in a person's closest relatives. This new need for family health history will demand a more
      comprehensive family history dataset for all patients, and the time limitations faced by
      healthcare providers demand a technology-driven solution whereby the patient performs primary
      data entry and the provider then refines these data. Solutions do not currently exist by
      which most Americans can organize their family health history and then place it into their
      electronic health record (EHR). My Family Health Portrait (MFHP) is an open source,
      electronic family history collection tool developed by the Surgeon General that offers
      interoperability with EHRs, yet to our knowledge has not been widely integrated because of
      limitations in the capacity of many EHRs to accept these data, and barriers to the systematic
      collection of these data in clinical practice. Additionally, obstacles exist for those
      individuals who are not computer literate or do not have access to a home computer. In order
      to capture patient-generated family history data across diverse patient populations, EHR's
      may need to offer patients a variety of data entry options which allow for differences in
      preference, convenience, computer literacy, and computer availability. This proposal seeks to
      develop new resources for family history data entry into the EHR. These resources will be
      developed, tested and validated in a primary care setting within of a large complex
      healthcare system.

      Research Plan: The proposed project will examine the reach, effectiveness, adoption and
      implementation of three innovative portals to transfer and integrate patient generated family
      history data with an EHR.

      Specific Aim 1 (technical development) is to develop the three portals for entry of patient
      generated family history data integrated with an EHR. The pathways will include: : (1)
      computer tablets in waiting rooms to complete the MFHP, (2) a secure internet portal to
      transfer data collected by patients at home using MFHP, and (3) an interactive voice response
      (IVR) system to collect the necessary data elements by phone. Each of these modalities will
      interface with the EHR of a large health delivery system using current data standards. Each
      of these modalities will be designed to interface with the EHR of a large health delivery
      system using current data standards using current data standards.

      Specific Aim 2 (content development and validation) is to evaluate facilitators and barriers
      to the adoption, and implementation of these three electronic portals by assessing
      differences in patient preferences, privacy concerns, convenience, and understanding. The
      validity of the family history data collected by each of these three portals will also be
      assessed by a genetic counselor.

      Specific Aim 3 (pilot randomized controlled trial) is to conduct a 4-armed pilot randomized
      controlled trial (RCT) to measure the reach and effectiveness of integrating this family
      history data with a patient's EHR. The trial will examine and compare changes in family
      history documentation, patient-doctor discussion of family history, and patient and provider
      satisfaction with each data entry portal described in Aim 1, as well as a control arm. The
      trial will be conducted as a pilot cluster RCT in selected practices within the Brigham and
      Women's Primary Care Practice-Based Research Network.

      Potential Impact: The impact of obtaining accurate family history data and integrating this
      with an individual's health record are substantial, and will be of growing importance as our
      understanding of the genome advances. This project will ultimately contribute to a better
      understanding of how available technologies can be integrated with EHR's to obtain accurate
      family history in ways that allow for widespread acquisition and integration of accurate
      family history data in a variety of settings and diverse patient populations. The technology
      and lessons learned from this project will be exportable to healthcare settings throughout
      the United States.
    

Intervention name(s): Electronic Health Portals for collecting Family History data
Intervention type(s): Other
Intervention description(s): Comparison of multiple portals for integrating patient generated family history data into the electronic health record.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Family History; Electronic Health Record