Relational Agent for Alcohol Screening and Treatment

Background: VA has demonstrated national leadership by implementing electronic clinical
reminders and establishing performance measures for both screening and brief intervention for
unhealthy alcohol use. Nationally, about 93% of Veterans are screened annually. However, the
percentage of brief interventions delivered when needed, and the quality and effectiveness of
those interventions, are uncertain. A patient centered computer-based intervention can help
to close the performance gap by delivering a tailored intervention with excellent quality and
fidelity. Relational Agents are on-screen characters that speak to the patient and establish
a "relationship" with them.

They have been used to improve several health behaviors including diet and exercise, and can
overcome communication barriers related to low levels of computer literacy. The Relational
Agent can be placed on a desktop or tablet computer with a touch screen, on which patients
indicate their responses. Using Motivational Interviewing and behavior change principles, the
Relational Agent guides patients to consider change. Use of such an "eHealth" tool offloads a
time-intensive task from the clinician while providing the patient, who may have limited
computer skills, a non-threatening vehicle for "discussing" a stigmatized topic such as risky
alcohol use. Relational Agents have proven more effective than web-based interventions in
promoting health-related behavior changes in some studies. Pilot studies at VA Boston
demonstrate that Veterans will engage with Relational Agents and view them favorably. To
date, there have been no VA trials of Relational Agents.

Aims:

- 1) Tailor the Relational Agent Intervention to the Veteran population

- 2) Conduct a randomized controlled trial of Treatment as Usual plus the Relational Agent
versus Treatment as Usual for unhealthy alcohol use

- 3) Examine in-depth Veterans' experience with the Relational Agent Intervention.

Methods: To achieve Aim 1, the investigators will use standard software development
techniques, including cognitive interviewing and usability testing, to tailor the Relational
Agent Intervention to the Veteran population. Once the Relational Agent is refined, the
investigators will conduct a two-arm RCT (Aim 2) in the VA Boston Healthcare System. The
investigators will randomize Veterans in primary care to Treatment as Usual plus the
Relational Agent versus Treatment as Usual, using a stratified randomization scheme to ensure
equal numbers of Veterans with unhealthy alcohol use (risky and hazardous drinking) and
Veterans with alcohol use disorders (a more severe classification) in each group. Working
closely with primary care staff, who routinely screen Veterans for risky alcohol use, the
investigators will identify Veterans who screen positive and ask them to participate in the
study. The investigators will recruit 180 Veterans over 15 months, with a goal of completing
the study with 126 to 144 participants. Veterans allocated to the Relational Agent
Intervention arm will interact with the Relational Agent at the time of the primary care
visit and will be scheduled for a one-month follow-up visit for a second interaction with the
Relational Agent.

The Relational Agent will provide personal feedback for the Veteran and the clinician, and
will flag Veterans who meet criteria for referral to treatment. Alcohol use and related
behaviors will be assessed by in-person survey at baseline and by telephone survey at a
3-month follow-up. Primary outcome measures will be quantity and frequency of alcohol use at
the 3-month follow-up, with rates of brief intervention, referral to treatment, and
satisfaction as secondary outcomes. Subgroup analyses will allow for examining separately the
effects of the Relational Agent on unhealthy alcohol use and on Veterans with alcohol abuse
or dependence.

Following the RCT, the investigators will conduct a formative evaluation (Aim 3), with
in-depth interviews, to characterize the elements of the Intervention that emerge as most
effective and those that seem extraneous or even counter-productive.

Inclusion Criteria:

Veterans receiving Primary Care at VA Boston Healthcare System.

- age 18 years or older,

- having a primary care provider at any primary care clinic in VABHCS,

- having a positive screen on the AUDIT-C.

- have a stable address and/or phone number for 6 months

- willing to provide the contact information for at least one locator

Exclusion Criteria:

- The investigators will exclude Veterans with cognitive impairment that would preclude
their ability to use the Relational Agent

- The investigators will use their ability to read and understand the consent form
as a screen for this.

- In the investigators' pilot studies, the use of the 6-item screener did not
result in excluding anyone.

- no substance abuse treatment in the last 30 days