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Trial Embedded in an Electronic Personal Medical Health Records

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972348
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : November 20, 2013
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a research study to determine if a personal health record, called myHERO, will help improve health. A personal health record is a secure internet (also called online) tool that contains personal health information like medications, diagnosed conditions, allergies and laboratory values (like CD4 cells and viral load). This study will also help explain if a personal health record influences the relationship with a doctor or nurse practitioner and their patients. The purpose of this study is to determine if a personal health record will influence health. The content of your personal health record is as secure as possible for any online health information.

Condition or disease Intervention/treatment Phase
HIV Infections Health Literacy Other: Online access to a personal health record Other: No access to the PHR Not Applicable

Detailed Description:

HIV/AIDS is a non-curable chronic illness. Applying the chronic care model (CCM) to this disease may lead to improved outpatient based health care and easier clinical transitions for HIV infected patients. Clinical information systems (CIS) are a key element in the CCM and have three important roles: reminder systems; feedback mechanisms; and registries. CIS have focused on the provider as the recipient of critical data, however clinical information systems that target patients as consumers of information might also contribute to improved health care, especially for ambulatory patients. Personal health records (PHRs) are tools that would fit as a clinical information system for patients. PHRs allow patients (and others) to view data that are necessary to guide practical outpatient decisions. PHRs can become platforms to support the CIS elements too, allowing patients to receive and understand information, engage in their healthcare and influence their health outcomes. Our central hypothesis is that a secure enhanced PHR (ePHR) that combines meaningful information, web-based tools for support and reminders for patients will also provide a substantial opportunity to promote self-management and will lead to improved health outcomes. In this proposal we will work directly with HIV/AIDS patients in a public health setting to model processes that contribute to improved health outcomes in the realms of patient behaviors, patient-clinician trust, clinical outcomes, medication safety and utilization. Accordingly, the specific aims are:

  1. (Build Infrastructure and Content) Extend and secure a web-based PHR for HIV/AIDS patients receiving care in a public health setting providing these users with tools to access and understand their medical record including resources for decision support, information retrieval and communication. Specific content will include access to support for tobacco cessation, depression abatement, anxiety reduction, and medication adherence improvement.
  2. (Evaluation of PHR) Evaluation of patient and clinician experience with PHR including patient access and use patterns including use of support for tobacco cessation, depression abatement, anxiety reduction, adherence improvement., patient and clinician satisfaction with ePHR.
  3. (Outcome Assessment) Evaluation in 5 domains: quality of the patient-clinician interaction (trust, communication, health promotion); changes in patient behaviors (risk behaviors, adherence to antiretroviral medications, tobacco use); clinical outcomes (CD4+ T-lymphocytes, detectable plasma HIV RNA, depression, anxiety, quality of life); safety (documentation of drug allergies, adverse events, medication reconciliation); and utilization (office visits).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial Embedded in an Electronic Medical Record (myHERO).
Study Start Date : July 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Access to Personal Health Record
Full access to the Personal Health Record including lists of diagnoses, medications and laboratory values.
Other: Online access to a personal health record
Patients in the intervention arm have full access to their online personal health record

Active Comparator: No access to the PHR
No access to the PHR but patients will complete surveys.
Other: No access to the PHR
Patients will not be given access to their PHR but will complete online surveys.

Primary Outcome Measures :
  1. The primary analyses of the trial data will compare the two study groups with respect to (1) 12-month change in CD4 T-cell count and (2) 12-month proportion of patients whose HIV viral load (VL) level is detectable. [ Time Frame: 12 months of participation ]

Secondary Outcome Measures :
  1. Alleviation of depression, among patients who are depressed at baseline. [ Time Frame: 12 months ]
  2. Smoking cessation, among patients who are smokers at baseline. [ Time Frame: 12 months ]
  3. Trust between physicians and patients. [ Time Frame: 12 months ]
  4. Medication reconciliation. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Evidence of HIV-1 infection, based on patient's medical history or laboratory tests.
  2. 18 years of age or older
  3. Receiving primary medical care at the Positive Health Program, SFGH.
  4. Able and willing to give informed consent.
  5. Willing to use the patient portal

Exclusion Criteria:

  1. Unwilling or unable to provide informed consent.
  2. No access to the web at any convenient location.
  3. Not willing to respond to online surveys or questionnaires.
  4. Already with access to the myHERO system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00972348

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United States, California
HIV AIDS outpatient clinic at Ward 86
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: James Kahn, MD University of California
Study Director: David Thom, MD, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT00972348    
Other Study ID Numbers: H2598-33964
R18HS017784 ( U.S. AHRQ Grant/Contract )
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013
Keywords provided by University of California, San Francisco:
Personal Health Record
Laboratory values: CD4 cells and HIV Viral load
Medication Reconciliation
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases