Trial Embedded in an Electronic Personal Medical Health Records

HIV Infections Clinical Trial

Official title:

A Randomized Controlled Trial Embedded in an Electronic Medical Record (myHERO).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972348
• Other study ID #: H2598-33964
• Secondary ID: R18HS017784
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: November 18, 2013
• Start date: July 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Health Literacy
• HIV Infections

Intervention

Other:
• Online access to a personal health record
Patients in the intervention arm have full access to their online personal health record
• No access to the PHR
Patients will not be given access to their PHR but will complete online surveys.

Locations

Country	Name	City	State
United States	HIV AIDS outpatient clinic at Ward 86	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months of participation	No
Secondary	Alleviation of depression, among patients who are depressed at baseline.		12 months	No
Secondary	Smoking cessation, among patients who are smokers at baseline.		12 months	No
Secondary	Trust between physicians and patients.		12 months	No
Secondary	Medication reconciliation.		12 months	No