Clinical trial NCT00977847: Integrating Patient Generated Family Health History From Varied Electronic Health Record (EHR) Entry Portals
Official title: Integrating Patient Generated Family Health History From Varied Electronic Health Record Entry Portals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Characteristics
Health Status
Family Research
Keywords: Family History
Electronic Health Record
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

Male and Female Patients who:

* receive primary care at one of the study selected Primary Care Practices,
* are between 18-75 years old,
* are English or Spanish speakers, and
* have appointments scheduled in the upcoming 1 - 3 months for an annual or comprehensive visit.

Exclusion Criteria:

* We will not include individuals over the age of 75 because the role of family risk assessment and prevention is less established.
* Also will not include non-English or non-Spanish speakers.
* Patients will also be excluded if they are hearing impaired.

Primary outcomes:
measure: Project will seek to demonstrate that family history data can be accurately reported by 5000 diverse patients using three portals, and that these data can be used to tailor an individual's health care based on their familial risk.
timeFrame: 2.5 years
Secondary outcomes:
measure: Develop three portals for collection of patient generated family history data integrated with an EHR: computer tablets in waiting rooms; a secure internet portal for use at home; and an interactive voice response system to get data by phone.
timeFrame: 1.5 years
measure: Evaluate facilitators and barriers to adoption and implementation of these portals by assessing differences in patient preferences, privacy, convenience, and understanding. Validate data collected by each portal by a genetic counselor.
timeFrame: 1.5 years
measure: To conduct a 4-armed pilot RCT to measure the reach and effectiveness of integrating family history data with a patient's EHR.
timeFrame: 2 years
measure: For patients in the RCT who report a family history that is associated with an increased risk of coronary artery disease, we will examine how often their physician initiates screening and/ or primary prevention based on the family history information.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jennifer S Haas, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
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