Trial Embedded in an Electronic Personal Medical Health Records
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|ClinicalTrials.gov Identifier: NCT00972348|
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : November 20, 2013
|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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||338 participants|
|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|
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.
- 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 ]
- Alleviation of depression, among patients who are depressed at baseline. [ Time Frame: 12 months ]
- Smoking cessation, among patients who are smokers at baseline. [ Time Frame: 12 months ]
- Trust between physicians and patients. [ Time Frame: 12 months ]
- Medication reconciliation. [ Time Frame: 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00972348
|United States, California|
|HIV AIDS outpatient clinic at Ward 86|
|San Francisco, California, United States, 94110|
|Principal Investigator:||James Kahn, MD||University of California|
|Study Director:||David Thom, MD, PhD||University of California, San Francisco|