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Patient Portal to Support Treatment Adherence

NCT ID: NCT00923624

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-09-30

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.

Conditions

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Antiretroviral Medication Adherence

Keywords

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electronic medical record antiretroviral medication adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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staff emails

Attention control that includes staff sending emails with information about using health information technology system.

Group Type ACTIVE_COMPARATOR

attention control

Intervention Type OTHER

9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them.

study nurse messages

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.

Group Type EXPERIMENTAL

adherence intervention

Intervention Type BEHAVIORAL

9 messages tailored by the study nurse and guided by the IMB model

Interventions

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attention control

9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them.

Intervention Type OTHER

adherence intervention

9 messages tailored by the study nurse and guided by the IMB model

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheryl L. Catz, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Northern California

Oakland, California, United States

Site Status

Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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5R01MH081750

Identifier Type: NIH

Identifier Source: secondary_id

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5R01MH081750

Identifier Type: NIH

Identifier Source: org_study_id

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