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Trial Embedded in an Electronic Personal Medical Health Records

NCT ID: NCT00972348

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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).

Conditions

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HIV Infections Health Literacy

Keywords

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HIV Personal Health Record Laboratory values: CD4 cells and HIV Viral load Medication Reconciliation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Access to Personal Health Record

Full access to the Personal Health Record including lists of diagnoses, medications and laboratory values.

Group Type EXPERIMENTAL

Online access to a personal health record

Intervention Type OTHER

Patients in the intervention arm have full access to their online personal health record

No access to the PHR

No access to the PHR but patients will complete surveys.

Group Type ACTIVE_COMPARATOR

No access to the PHR

Intervention Type OTHER

Patients will not be given access to their PHR but will complete online surveys.

Interventions

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Online access to a personal health record

Patients in the intervention arm have full access to their online personal health record

Intervention Type OTHER

No access to the PHR

Patients will not be given access to their PHR but will complete online surveys.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Kahn, MD

Role: PRINCIPAL_INVESTIGATOR

University of California

David Thom, MD, PhD

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

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HIV AIDS outpatient clinic at Ward 86

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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R18HS017784

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

H2598-33964

Identifier Type: -

Identifier Source: org_study_id