Unhealthy Alcohol UseRAASTNCT02030288
Relational Agent for Alcohol Screening and Treatment
A study testing Relational Agent Intervention in people with Unhealthy Alcohol Use and Alcohol Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unhealthy Alcohol Use, Alcohol Use Disorder, Alcohol Disorders
- What is being tested?
- Relational Agent Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2015to 23 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Official title: Relational Agent to Improve Alcohol Screening and Treatment in Primary Care: RCT
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.
Read the 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.
- Being tested
- Relational Agent Intervention
- Keywords
- alcohol, substance use, eHealth
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relational Agent InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3-month follow up
Secondary outcomes (3)
Drinking Days Per Week (DDPW)
Drinking Days Per Week is the number of days that a participant has an alcoholic beverage (x/7). It is a measure of the frequency of alcohol use. This is averaged over 30 days.
Measured: baseline and 3-month follow up
Brief Intervention
For Treatment as Usual, a liberal definition was used. If the provider indicated on the EMR checklist that they advised the patient to cut down or quit, we counted that as a brief intervention. There are additional expectations for a brief intervention in the checklist, however we applied the most minimal standards for providers. For the Relational Agent intervention, participants who completed the first visit were counted as receiving the brief intervention.
Measured: 3-month follow-up
Referral to Speciality Care for Alcohol Problem
Whether patient was referred for specialty care if indicated by AUD-C score. This is simply a count of those referred to specialty substance abuse treatment.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study start19 Feb 2015
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unhealthy Alcohol UseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Northeastern University, Boston University
- Responsible party
- Sponsor
- Investigators
- Steven R Simon, MD MPH BS, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030288
- Sponsor's protocol ID
- IIR 11-334
- Acronym
- RAAST
- Status last verified
- Sep 2020
- First submitted
- 30 Dec 2013
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34145518
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relational Agent to Improve Alcohol Screening and Treatment in Primary Care: RCT
- ClinicalTrials.gov ID
- NCT02030288
- Acronym / sponsor ID
- RAAST / IIR 11-334
- Keywords
- alcohol, substance use, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Northeastern University, Boston University
- Study start
- 19 Feb 2015 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relational Agent plus Treatment as Usual | Experimental | Behavioral: Relational Agent InterventionRelational 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- The investigators will exclude Veterans with cognitive impairment that would preclude their ability to use the Relational Agent
- no substance abuse treatment in the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relational Agent InterventionRelational 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. | Behavioural | Relational Agent plus Treatment as Usual |
Primary outcome
Drinks Per Drinking Day (DDPW)
Time frame: baseline and 3-month follow up
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.
3 secondary outcomes
Drinking Days Per Week (DDPW)
Time frame: baseline and 3-month follow up
Brief Intervention
Time frame: 3-month follow-up
Referral to Speciality Care for Alcohol Problem
Time frame: 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34145518Rubin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Simon, MD MPH BS principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relational Agent Intervention in people with Unhealthy Alcohol Use and Alcohol Use Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks Per Drinking Day (DDPW) (time frame: baseline and 3-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.