Patient Portal to Support Treatment Adherence

Study Overview
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Brief Summary
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The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by nurses via an electronic medical record (EMR) patient web portal to determine if this is an efficacious method for supporting medication adherence.

Detailed Description
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300 adult HIV+ patients will be randomized to one of two arms. 150 will be assigned to receive secure messages focused on antiretroviral adherence from a nurse through the health plan EMR patient website. 150 will be assigned to an attention control comparison arm, and will receive electronic messages from a study staff member that provide information about the various features of the health plan patient website. Patients will be invited by mail to be telephone screened for enrollment in the study. Patients will be provided the opportunity to opt out of being contacted by the study. Eligible and interested patients will be mailed an access code and separately emailed a link to a secure study website where they will complete a web consent form and a baseline web survey before being randomized to an intervention arm. This trial will allow us to evaluate the effectiveness of using health information technology as an intervention delivery vehicle to improve patient disease management behaviors such as treatment adherence.

Official Title
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Patient Portal to Support Treatment Adherence

Conditions
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Antiretroviral Medication Adherence

Intervention / Treatment
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* Other: attention control
* Behavioral: adherence intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrollment in GHC or KP health plans for at least 6 months expect to stay enrolled for 1 year in health plan HIV+ currently prescribed antiretroviral medication regular access to a computer with internet capabilities and working email address and meet one of the following: gap in antiretroviral prescription refills based on 6 month refill records referral to study by provider team for adherence problems Exclusion Criteria: dementia or psychosis diagnosis documented in medical record

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: staff emails<br>Attention control that includes staff sending emails with information about using health information technology system. | Other: attention control<br>* 9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them.<br>|
| Experimental: study nurse messages<br>A series of 6 proactive secure messages and 3 proactive booster messages (for a total of 9 secure and personalized messages) sent by the study nurse via the EMR patient web portal. | Behavioral: adherence intervention<br>* 9 messages tailored by the study nurse and guided by the IMB model<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records). |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Web service utilization. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic medical record, antiretroviral medication adherence