Patient Portal to Support Treatment Adherence

Not Applicable

Completed

• Conditions: Antiretroviral Medication Adherence
• Interventions: Other: attention control; Behavioral: adherence intervention

• Registration Number: NCT00923624
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
staff emails	attention control	Attention control that includes staff sending emails with information about using health information technology system.
study nurse messages	adherence intervention	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Web service utilization.	12 months

Trial Locations

Locations (2)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States