Trial Embedded in an Electronic Personal Medical Health Records

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Health Literacy
• Intervention / Treatment: Other: Online access to a personal health record; Other: No access to the PHR

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).

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • HIV AIDS outpatient clinic at Ward 86

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Alleviation of depression, among patients who are depressed at baseline.	12 months
Smoking cessation, among patients who are smokers at baseline.	12 months
Trust between physicians and patients.	12 months
Medication reconciliation.	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: James Kahn, MD, University of California; Study Director: David Thom, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 3, 2009
• First Submitted That Met QC Criteria: September 3, 2009
• First Posted (Estimate): September 4, 2009

Study Record Updates

• Last Update Posted (Estimate): November 20, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: HIV; Medication Reconciliation; Personal Health Record; Laboratory values: CD4 cells and HIV Viral load
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: H2598-33964; R18HS017784 (U.S. AHRQ Grant/Contract)