NCT02030288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 19, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 1, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

3.7 years

First QC Date

December 30, 2013

Results QC Date

May 6, 2020

Last Update Submit

September 29, 2020

Conditions

Unhealthy Alcohol UseAlcohol Use DisorderAlcohol Disorders

Keywords

alcoholsubstance useeHealth

Outcome Measures

Primary Outcomes (1)

  • Drinks Per Drinking Day (DDPW)

    Average number of drinks consumed on days when the participant drinks. For instance, if someone drinks 4 drinks on 3 separate days, their average drinks per drinking day is 4.

    baseline and 3-month follow up

Secondary Outcomes (3)

  • Drinking Days Per Week (DDPW)

    baseline and 3-month follow up

  • Brief Intervention

    3-month follow-up

  • Referral to Speciality Care for Alcohol Problem

    3-month follow-up

Study Arms (2)

Relational Agent plus Treatment as Usual

EXPERIMENTAL

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.

Behavioral: Relational Agent Intervention

Treatment as Usual

NO INTERVENTION

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.

Interventions

Relational Agent InterventionBEHAVIORAL

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.

Relational Agent plus Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • 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.

    PMID: 34145518DERIVED

MeSH Terms

Conditions

AlcoholismAlcohol-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Nicholas Livingston
Organization
VA Boston Healthcare System
nicholas.livingston@va.gov
857-364-6360

Study Officials

  • Steven R Simon, MD MPH BS

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 8, 2014

Study Start

February 19, 2015

Primary Completion

October 23, 2018

Study Completion

October 23, 2018

Last Updated

October 1, 2020

Results First Posted

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)