Relational Agent for Alcohol Screening and Treatment

NCT ID: NCT02030288

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-19
• Study Completion Date: 2018-10-23

Brief Summary

This project will involve the development and initial evaluation of a promising computer-based intervention to improve the primary care management of risky alcohol use among Veterans. The intervention uses a Relational Agent, an on-screen "person" that establishes a relationship with the Veteran to promote positive health behaviors. This study will determine how Veterans interact with this system, how it can be tailored to Veterans' preferences, and its potential effect on risky drinking. If ultimately proven effective, the Relational Agent will have several impacts on Veterans and their health care, including:

• (1) lower rates of risky drinking in Veterans
• (2) improved rates of brief counseling for Veterans with excessive alcohol use
• (3) increased proportion of Veterans referred to Mental Health for alcohol disorders
• (4) improved care for Veterans with low levels of health literacy.

This study directly supports Secretary Shinseki's Transformational Initiative to employ state-of-the-art information technology to improve quality and access of Veterans' health care.

Detailed Description

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.

Conditions

Unhealthy Alcohol Use; Alcohol Use Disorder; Alcohol Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Relational Agent plus Treatment as Usual

Relational Agents are onscreen 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.

Group Type: EXPERIMENTAL

Relational Agent Intervention

Intervention Type: BEHAVIORAL

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.

Treatment as Usual

Patients are routinely screened yearly for unhealthy alcohol use. Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUDIT-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Relational Agent Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northeastern University

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Simon, MD MPH BS

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Countries

United States

References

Rubin A, Livingston NA, Brady J, Hocking E, Bickmore T, Sawdy M, Kressin N, Saitz R, Simon S. Computerized Relational Agent to Deliver Alcohol Brief Intervention and Referral to Treatment in Primary Care: a Randomized Clinical Trial. J Gen Intern Med. 2022 Jan;37(1):70-77. doi: 10.1007/s11606-021-06945-9. Epub 2021 Jun 18.

Reference Type: DERIVED

PMID: 34145518 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IIR 11-334

Identifier Type: -

Identifier Source: org_study_id