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Patient Portal to Support Treatment Adherence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00923624
First received: June 17, 2009
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Antiretroviral Medication Adherence
 Other: attention control
Behavioral: adherence intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Portal to Support Treatment Adherence

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Web service utilization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: staff emails
Attention control that includes staff sending emails with information about using health information technology system.
 Other: 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.
Experimental: 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.
 Behavioral: adherence intervention
9 messages tailored by the study nurse and guided by the IMB model

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923624

Locations
United States, California
Kaiser Permanente Northern California
Oakland, California, United States, 94612
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Kaiser Permanente
Investigators
Principal Investigator: Sheryl L. Catz, PhD Group Health Cooperative
  More Information

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00923624     History of Changes
Other Study ID Numbers: 5R01MH081750, 5R01MH081750
Study First Received: June 17, 2009
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
electronic medical record
antiretroviral medication adherence

ClinicalTrials.gov processed this record on May 22, 2013