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IIR 11-334 – HSR&D Study

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IIR 11-334
Relational Agent to Improve alcohol Screening and Treatment in Primary Care: RCT
Steven R Simon MD MPH BS
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, MA
Funding Period: July 2014 - March 2019

BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
Objectives: The study aims are to 1) Tailor the Relational Agent Intervention to the Veteran population; 2) Conduct a randomized controlled trial of Treatment as Usual versus Treatment as Usual plus the Relational Agent for unhealthy alcohol use; and 3) Examine in-depth Veterans' experience with the Relational Agent Intervention.

METHODS:
Methods: 1) We will use cognitive interviewing and usability testing to tailor the Relational Agent Intervention to the Veteran population. 2) We will conduct a two-arm RCT in the VA Boston Healthcare System. We will randomize Veterans in primary care to Treatment as Usual versus Treatment as Usual plus the Relational Agent, using a stratified randomization scheme to ensure equal numbers of Veterans with risky drinking and Veterans with alcohol use disorders in each group. Working closely with primary care staff we will identify Veterans who screen positive and ask them to participate in the study. We will recruit 180 Veterans over 15 months, with a goal of completing the study with 126 participants. Veterans in 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 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. there will bea 3-month telephone 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 risky drinking and on Veterans with alcohol use disorders. Aim 3)We will conduct a formative evaluation 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.

FINDINGS/RESULTS:
Preliminary Findings: We recruited 4 women and 16 men for Aim 1. We showed them up to 10 different characters (possible relational agents) and asked them for both quantitative and qualitative feedback on these characters. In general Veterans preferred a female character wearing business-like clothes in an office setting as opposed to male characters wearing casual clothes or lab coats, in a living room or other settings. Veterans preferred characters that showed more empathy using voice and facial expressions.
Next we showed these veterans the mostly complete program and used a "think-aloud" protocol to gather their feedback. We are using this feedback to modify the program in line with users' experience where possible.
Aim 2 is almost completed. we have recruited 179 participants
and we are finishing follow-up meetings. We also have one more Aim 3 interview to complete. Data analysis of both baseline data for RCT and Aim 3 qualitative interviews are underway.

IMPACT:
Impact: We will evaluate whether a novel eHealth intervention can improve brief counseling for risky drinking and alcohol problems while alleviating the burden on primary care clinicians.

PUBLICATIONS:
None at this time.


DRA: Substance Abuse and Addiction
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Addictive Disorders
MeSH Terms: none