Randomized Controlled Trial Embedded in an Electronic Health Record (California)

Project Details - Ended

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Summary:

The use of a personal health record (PHR) may improve a patient’s overall health by providing access to health information that helps them to better manage their care. PHRs allow patients to receive information, view data necessary to guide practical decisions, and communicate with their health care team.

This project expanded an existing PHR to add established tools to assess tobacco use, depression, anxiety, and medication adherence, and to translate responses into numeric scores that trigger decision support for patients and direct them to resources or Web-based interventions. The PHR was made available to HIV-positive individuals at a safety net institution to see if medication adherence would improve. Lower viral loads and higher CD4 counts were used as surrogate markers for improved health. A randomized study was conducted with half of the target patients being given full and immediate access to the PHR and the other half with no access. All of the patients were given computer and Internet training, as well as a list of places with free Internet so they could access it at any time.

Specific aims of this project were to:

  • Build the infrastructure and content of the PHR to provide patient decision support, information retrieval, and communication tools.
  • Evaluate patient and provider experiences using the PHR, including patient access and use of health education materials and patient-provider satisfaction with the PHR.
  • Assess outcomes, including quality of patient-provider interactions, changes in patient behaviors, clinical outcomes, safety, and health services utilization.         

From December 2009 to April 2011, HIV-positive adults receiving care at the HIV/AIDS Clinic at the San Francisco General Hospital who had consented to participate in the study were randomized to receive 12 months of access to a Web-based PHR (157), or to an account that withheld the PHR information (181). Participants were asked to complete Web-based surveys that were housed in their PHRs to ensure that patients were exposed to their health information. Non-PHR participants accessed these surveys via a Web portal. Use of the PHR was measured via the number of logins, cumulative time spent logged in, and numbers completing at least one survey at various stages of the study. More than 60 percent of participants demonstrated intermediate or expert computer competencies that would enable them to use health information technology tools to improve their connection with health care resources, including the ability to receive, search, and retrieve information via the Internet.

The study found that patients used the PHR and responded to online surveys, although participant understanding of the information was not measured. Despite this, there was no difference in the viral load or CD4 counts between the two groups at the end of the study.  The study team had three theories as to why a difference was not noted: 1) that the technology might not be sufficient to influence medication adherence; 2) that while the technology might be able to make such an impact, it was not used correctly in this study; and 3) that while technology is able to make an impact and was used correctly, it does not work in this particular population. A final consideration was that medications used to treat HIV/AIDS are so effective that tools to augment adherence are unable to enhance their anti-HIV effects.

The study team concluded that the use of technology likely has an important role as a social force to link otherwise disconnected patients to a social network. They recommend further studies to evaluate the impact of social networks on health outcomes.

Randomized Control Trial Embedded in an Electronic Health Record - 2012

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS08-002: Ambulatory Safety and Quality Program: Improving Management of Individuals with Complex Healthcare Needs through Health Information Technology (MCP)
  • Grant Number: 
    R18 HS 017784
  • Project Period: 
    September 2008 - August 2012
  • AHRQ Funding Amount: 
    $1,199,928
  • PDF Version: 
    (PDF, 261.89 KB)

Summary: Because AIDS is a chronic illness, applying the chronic care model (CCM) to patients with AIDS may lead to improved outpatient care and easier, safer clinical transitions. Clinical information systems (CISs) are a key element in the CCM. While most CISs have focused on the provider as the recipient of critical data, CISs that target patients might also improve health care. Personal health records (PHRs) are increasingly common applications and typically function as repositories of clinical data, allowing patients to receive information, partake of their health care, and view data necessary to guide practical decisions.

Dr. Kahn and his team developed an easy-to-use, secure PHR for HIV-positive people who are seeking care at a safety-net care clinic at San Francisco General Hospital. Participants were randomized to receive 12 months’ access to a Web-based PHR (“PHR” group) or to an account that withheld the PHR information (“no PHR” group) until study followup was complete. Both groups received computer and Internet training and a list of sites where participants could access the Internet for free. The team conducted a randomized controlled study to determine if the PHR would assist with patient health care as determined by surrogate markers for immunologic health (higher CD4 cells and lower viral load). Most PHRs provide data via secure Internet portals but patients receiving care in safety-net settings may have limited access to the Internet and inadequate technical competency and health literacy, which constrains engagement with PHR applications. Therefore the team sought to determine if people with HIV infection and mental health and/or substance use (MH/SU) diagnoses were able and willing to use a PHR. They also sought to understand the skill sets that individuals with MH/SU had at baseline and requirements to access PHRs successfully.

Specific Aims:

  • Build the infrastructure and content of the PHR to provide patient decision support, information retrieval, and communication tools. (Achieved)
  • Evaluate patient and provider experiences using the ePHR, including patient access and use of health education materials and patient-provider satisfaction with the PHR. (Achieved)
  • Assess outcomes, including quality of patient-provider interactions, changes in patient behaviors, clinical outcomes, safety, and health services utilization. (Achieved)

2012 Activities: Dr. Kahn and his research team used a 12-month no-cost extension to complete the project. An article, A cross-sectional study of barriers to personal health record use among patients attending a safety-net clinic, was published in the PLoS One Journal in early 2012. The project ended in August 2012.

Impact and Findings: There was no difference in CD4 cell count or viral load between the two groups. The project team speculates that while using this technology may not be a powerful tool to influence biology, it may serve as a social force to link otherwise-disconnected patients to a social network. Further studies will need to ascertain if access to a social network influences health outcomes.

The research team found that MU/SU conditions were not barriers to engagement with Web-based health information. Level of computer competency was a way to identify individuals who required substantial computer training in order to fully participate in the study.

Target Population: Adults, Chronic Care*, HIV/AIDS

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

* This target population is one of AHRQ's priority populations.

Randomized Controlled Trial Embedded in an Electronic Health Record - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS08-002: Ambulatory Safety and Quality Program: Improving Management of Individuals with Complex Healthcare Needs through Health Information Technology (MCP)
  • Grant Number: 
    R18 HS 017784
  • Project Period: 
    September 2008 - August 2012
  • AHRQ Funding Amount: 
    $1,199,928
  • PDF Version: 
    (PDF, 187.21 KB)

Summary: HIV/AIDS is a chronic illness and applying the chronic care model (CCM) to this disease may lead to improved outpatient care and easier, safer clinical transitions for HIV-infected patients. Clinical information systems (CISs) are a key element in the CCM. While most CISs have focused on the provider as the recipient of critical data, CISs that target patients might also improve health care. The electronic personal health record (ePHR) is a recent and increasingly common information system that allows patients to view data necessary to guide practical outpatient decisions and provides portability of clinical data between health care venues.

This project expanded an existing secure ePHR, called my Healthcare Evaluation Record Organizer (myHERO), to provide information, Web-based tools, and reminders to promote self-management, increase safer clinical transitions, and improve outcomes among patients with HIV/AIDS in a public health setting. myHERO is integrated with HERO, the electronic health record system used by the University of California at San Francisco's Positive Health Program, a primary care clinic that specializes in care for patients with HIV/AIDS. The enhancements included adding established tools to assess tobacco use, depression, anxiety, and medication adherence, and to translate responses into numeric scores that trigger decision-support for patients and directs them to resources or Web-based interventions.

A 12-month randomized controlled trial is evaluating the impact of the ePHR on clinical outcomes including: 1) qualities-i.e. trust, communication, and health promotion-of the patient-clinician interaction; 2) changes in patient behaviors such as adherence to antiretroviral medications and tobacco use; 3) clinical outcomes, i.e. CD4+ T-lymphocytes, detectable plasma HIV RNA, depression, anxiety, and quality of life; 4) safety, i.e. documentation of drug allergies, adverse events, and medication reconciliation; and 5) utilization, including office visits. In addition, the project team will evaluate patient and clinician experiences in engaging with the ePHR tools including patient access and use of support for tobacco cessation, depression abatement, anxiety reduction, adherence improvement, and patient and clinician satisfaction with the ePHR.

Specific Aims:

  • Build the infrastructure and content of the ePHR to provide patient decision support, information retrieval, and communication tools. (Achieved)
  • Evaluate patient and provider experiences using the ePHR, including patient access and use of health education materials and patient-provider satisfaction with the ePHR. (Ongoing)
  • Assess outcomes, including quality of patient-provider interactions, changes in patient behaviors, clinical outcomes, safety, and health services utilization. (Ongoing)

2011 Activities: Dr. Kahn and his research team completed data collection during 2011 and are using a 12-month no-cost extension to complete data analysis. An article, A cross-sectional study of barriers to personal health record use among patients attending a safety-net clinic, was submitted in 2011 and published in the PLoS One Journal in early 2012. Dr. Kahn did not submit a report with a status of activities or project spending in 2011 to the AHRQ Research Reporting System.

Preliminary Impact and Findings: The research team found that, among patients attending a safety-net HIV/AIDS clinic, mental health/substance abuse conditions were not barriers to engagement with Web-based health information. Level of computer competency was a way to identify individuals who required substantial computer training in order to fully participate in the study.

Target Population: Adults, Chronic Care*, HIV/AIDS

Strategic Goal:  Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

* This target population is one of AHRQ's priority populations.

Randomized Control Trial Embedded in an Electronic Health Record - 2010

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS08-002: Ambulatory Safety and Quality Program: Improving Management of Individuals with Complex Healthcare Needs through Health Information Technology (MCP)
  • Grant Number: 
    R18 HS 017784
  • Project Period: 
    September 2008 – August 2011
  • AHRQ Funding Amount: 
    $1,199,928
  • PDF Version: 
    (PDF, 362.18 KB)


Target Population: Adults, Chronic Care*, HIV/AIDS

Summary: HIV/AIDS is now considered a chronic illness. Therefore, the application of the chronic care model (CCM) to this disease may lead to improved outpatient care and easier, safer clinical transitions for HIV-infected patients. Clinical information systems (CISs) are a key element in the CCM. While most CISs have focused on the provider as the recipient of critical data, CISs that target patients might also improve health care. The electronic personal health record (ePHR) is a recent, increasingly common patient-oriented information system that allows patients to view data necessary to guide practical outpatient decisions and provide portability of clinical data between health care venues.

This project is expanding an existing secure ePHR, known as myHERO (Healthcare Evaluation Record Organizer), to provide information, Web-based tools, and reminders to promote self-management, increase safer clinical transitions, and improve outcomes among patients with HIV/AIDS in a public health setting. myHERO is integrated with HERO, the electronic health record system used by the University of California at San Francisco’s Positive Health Program, a primary care clinic that specializes in care for patients with HIV/AIDS. The enhancements included adding established tools to assess tobacco use, depression, anxiety, and medication adherence, and to translate responses into numeric scores that trigger decision-support for patients and direct them to resources or Web-based interventions.

A 12-month randomized controlled trial is evaluating the impact of the ePHR on clinical outcomes including: quality of the patient-clinician interaction such as trust, communication, and health promotion; changes in patient behaviors such as adherence to antiretroviral medications and tobacco use; clinical outcomes such as CD4+ T-lymphocytes, detectable plasma HIV RNA, depression, anxiety, and quality of life; safety, such as documentation of drug allergies, adverse events, and medication reconciliation; and utilization, such as office visits. In addition, the project team will evaluate patient and clinician experiences in engaging with the PHR tools including patient access and use of support for tobacco cessation, depression abatement, anxiety reduction, adherence improvement, and patient and clinician satisfaction with the ePHR.

This study builds on existing resources, experience, and expertise to provide a detailed evaluation of ePHR usage and its impact on health care outcomes in a public health setting. The ePHR could be a cost-effective approach to reducing health disparities and bridging the digital divide for underserved patients. The results of this study could have wide application and a potentially large impact on public health.

Specific Aims:

  • Build the infrastructure and content of the ePHR to provide patient decision support, information retrieval, and communication tools. (Achieved)
  • Evaluate patient and provider experiences using the ePHR, including patient access and use of health education materials and patient-provider satisfaction with the ePHR. (Ongoing)
  • Assess outcomes, including quality of patient-provider interactions, changes in patient behaviors, clinical outcomes, safety, and health services utilization. (Ongoing)

2010 Activities: Grantee did not report 2010 activities.

Grantee’s Most Recent Self-Reported Quarterly Status (as of September 2010): Grantee did not provide self assessment.

Preliminary Impact and Findings: This project does not have any reported findings to date.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

*AHRQ Priority Population.

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