Trial Outcomes & Findings for Relational Agent for Alcohol Screening and Treatment (NCT NCT02030288)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

178 participants

Primary outcome timeframe

baseline and 3-month follow up

Results posted on

2020-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Relational Agent Relational Agent Intervention 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.	Treatment as Usual Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.
Overall Study STARTED	89	89
Overall Study COMPLETED	89	89
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relational Agent for Alcohol Screening and Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment as Usual n=89 Participants Treatment as Usual Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.	Total n=178 Participants Total of all reporting groups	Relational Agent Plus Treatment As Usual n=89 Participants Relational Agent Intervention plus Treatment as Usual 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.
Age, Continuous	53.9 years STANDARD_DEVIATION 18.4 • n=7 Participants	51.7 years STANDARD_DEVIATION 18.0 • n=5 Participants	49.5 years STANDARD_DEVIATION 17.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=7 Participants	20 Participants n=5 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=7 Participants	158 Participants n=5 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized White	60 Participants n=7 Participants	120 Participants n=5 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized African American	14 Participants n=7 Participants	33 Participants n=5 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Latinx	7 Participants n=7 Participants	11 Participants n=5 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized other	8 Participants n=7 Participants	14 Participants n=5 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Relational Agent Plus Treatment as Usual n=89 Participants Relational Agent Intervention 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.	Treatment as Usual n=89 Participants Treatment as Usual Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.
Drinks Per Drinking Day (DDPW) DDPW at baseline	2.98 drinks per drinking day Standard Deviation 2.67	4.00 drinks per drinking day Standard Deviation 3.59
Drinks Per Drinking Day (DDPW) DDPW at 3 month follow-up	1.87 drinks per drinking day Standard Deviation 1.90	2.82 drinks per drinking day Standard Deviation 3.87

SECONDARY outcome

Timeframe: baseline and 3-month follow up

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.

Outcome measures

Outcome measures
Measure	Relational Agent Plus Treatment as Usual n=89 Participants Relational Agent Intervention 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.	Treatment as Usual n=89 Participants Treatment as Usual Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.
Drinking Days Per Week (DDPW) Drinking Days Per Week at baseline	4.07 drinking days per week Standard Deviation 2.11	4.72 drinking days per week Standard Deviation 1.93
Drinking Days Per Week (DDPW) Drinking Days Per Week at 3 month follow-up	3.26 drinking days per week Standard Deviation 2.13	3.83 drinking days per week Standard Deviation 2.21

SECONDARY outcome

Timeframe: 3-month follow-up

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.

Outcome measures

Outcome measures
Measure	Relational Agent Plus Treatment as Usual n=89 Participants Relational Agent Intervention 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.	Treatment as Usual n=89 Participants Treatment as Usual Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.
Brief Intervention	89 participants	63 participants

SECONDARY outcome

Timeframe: 3-month follow-up

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.

Outcome measures

Outcome measures
Measure	Relational Agent Plus Treatment as Usual n=89 Participants Relational Agent Intervention 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.	Treatment as Usual n=89 Participants Treatment as Usual Providers are prompted to provide elements of a brief intervention if the patient scores 5 or above on the AUD-C. Providers are also prompted to refer patients if they meet certain criteria for specialty alcohol treatment.
Referral to Speciality Care for Alcohol Problem	25 Participants	1 Participants

Adverse Events

Relational Agent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicholas Livingston

VA Boston Healthcare System

Phone: 857-364-6360

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place