Trial Embedded in an Electronic Personal Medical Health Records
Primary Purpose
HIV Infections, Health Literacy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online access to a personal health record
No access to the PHR
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring HIV, Personal Health Record, Laboratory values: CD4 cells and HIV Viral load, Medication Reconciliation
Eligibility Criteria
Inclusion Criteria:
- Evidence of HIV-1 infection, based on patient's medical history or laboratory tests.
- 18 years of age or older
- Receiving primary medical care at the Positive Health Program, SFGH.
- Able and willing to give informed consent.
- Willing to use the patient portal
Exclusion Criteria:
- Unwilling or unable to provide informed consent.
- No access to the web at any convenient location.
- Not willing to respond to online surveys or questionnaires.
- Already with access to the myHERO system
Sites / Locations
- HIV AIDS outpatient clinic at Ward 86
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Access to Personal Health Record
No access to the PHR
Arm Description
Full access to the Personal Health Record including lists of diagnoses, medications and laboratory values.
No access to the PHR but patients will complete surveys.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Alleviation of depression, among patients who are depressed at baseline.
Smoking cessation, among patients who are smokers at baseline.
Trust between physicians and patients.
Medication reconciliation.
Full Information
NCT ID
NCT00972348
First Posted
September 3, 2009
Last Updated
November 18, 2013
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00972348
Brief Title
Trial Embedded in an Electronic Personal Medical Health Records
Official Title
A Randomized Controlled Trial Embedded in an Electronic Medical Record (myHERO).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
(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.
(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.
(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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Health Literacy
Keywords
HIV, Personal Health Record, Laboratory values: CD4 cells and HIV Viral load, Medication Reconciliation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Access to Personal Health Record
Arm Type
Experimental
Arm Description
Full access to the Personal Health Record including lists of diagnoses, medications and laboratory values.
Arm Title
No access to the PHR
Arm Type
Active Comparator
Arm Description
No access to the PHR but patients will complete surveys.
Intervention Type
Other
Intervention Name(s)
Online access to a personal health record
Intervention Description
Patients in the intervention arm have full access to their online personal health record
Intervention Type
Other
Intervention Name(s)
No access to the PHR
Intervention Description
Patients will not be given access to their PHR but will complete online surveys.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Alleviation of depression, among patients who are depressed at baseline.
Time Frame
12 months
Title
Smoking cessation, among patients who are smokers at baseline.
Time Frame
12 months
Title
Trust between physicians and patients.
Time Frame
12 months
Title
Medication reconciliation.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Evidence of HIV-1 infection, based on patient's medical history or laboratory tests.
18 years of age or older
Receiving primary medical care at the Positive Health Program, SFGH.
Able and willing to give informed consent.
Willing to use the patient portal
Exclusion Criteria:
Unwilling or unable to provide informed consent.
No access to the web at any convenient location.
Not willing to respond to online surveys or questionnaires.
Already with access to the myHERO system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Kahn, MD
Organizational Affiliation
University of California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Thom, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
HIV AIDS outpatient clinic at Ward 86
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial Embedded in an Electronic Personal Medical Health Records
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