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Integrating Patient Generated Family Health History From Varied Electronic Health Record (EHR) Entry Portals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer S. Haas, MD, MSPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00977847
First received: September 14, 2009
Last updated: March 17, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Family Characteristics
Health Status
Family Research
 Other: Electronic Health Portals for collecting Family History data

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Integrating Patient Generated Family Health History From Varied Electronic Health Record Entry Portals

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • To conduct a 4-armed pilot RCT to measure the reach and effectiveness of integrating family history data with a patient's EHR. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interactive Voice Response Practice
The introductory letter to patients will allow them an opportunity to "opt-out" of the study using a toll-free number. If they do not opt-out within 2 weeks of receiving the letter, the IVR system will make up to 15 call attempts over a 2 week period to reach the patient. The system will make outbound calls during preset hours. The system continuously checks the call list for the next scheduled call. Once contact is made, the spoken script greets the patient by name, authenticates identify, and will ask the patient the programmed questions. The IVR server will send completed family history assessments to the patients EHR as an HL7 compliant summary note as well as transmitting the separate coded responses for each condition/ family member to coded family history fields in the EHR.
 Other: Electronic Health Portals for collecting Family History data
Comparison of multiple portals for integrating patient generated family history data into the electronic health record.
Experimental: Wireless Tablet PC Practice
Patients will receive an info letter in advance of their visit explaining the project with description of what information they will be asked to provide. Study staff will train the practice staff to hand out and collect the tablets for the patient. Staff will be trained to verify a patient's identity to ensure that the family history is sent to the correct EHR record. The initial screen of the tablet PC portal will include a paragraph of informed consent, and patients in this practice will be given the opportunity to decline participation. For patients who participate, the completed family history data will be transmitted to the patient's EHR as an HL7 compliant note and transmitting separate coded responses for each condition/ family member to coded family history fields.
 Other: Electronic Health Portals for collecting Family History data
Comparison of multiple portals for integrating patient generated family history data into the electronic health record.
Experimental: Internet Portal Practice
Patients in this practice will receive the informational letter either by email or mail one month before their scheduled visit. It will have directions to access the MFHP website and how to transfer data through the hospitals secure internet portal (Patient Gateway). About 1/3 of patients are signed up to use this service. Those who do not have a Patient Gateway account will be provided with directions on how to establish this service. Patients will be required to have a Gateway account to ensure that the MFHP data file is sent securely to the correct EHR record. Patients in this arm will receive an initial email or letter with a single follow-up reminder sent 2 weeks later. For patients who participate, the completed family history data will be transmitted to the patient's EHR.
 Other: Electronic Health Portals for collecting Family History data
Comparison of multiple portals for integrating patient generated family history data into the electronic health record.
Active Comparator: Usual Care Physician Assesment Practice
Usual standard family history assessments will be conducted by physicians during the patient visit. This arm will allow us to account for any temporal trends in family history assessment.
 Other: Electronic Health Portals for collecting Family History data
Comparison of multiple portals for integrating patient generated family history data into the electronic health record.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977847

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 S Haas, MD, MSPH Brigham and Women's Hospital
  More Information

Publications:

Responsible Party: Jennifer S. Haas, MD, MSPH, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00977847     History of Changes
Other Study ID Numbers: 2009P0011908, 1-RC1-HG005331-01
Study First Received: September 14, 2009
Last Updated: March 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Family History
Electronic Health Record

ClinicalTrials.gov processed this record on May 19, 2013