Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study

Study Overview
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Brief Summary
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The investigators have developed a hybrid computer- and person-delivered intervention, called C-Raven for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two  20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. These sessions are followed by elective in vivo initiation of nicotine replacement therapy (NRT). Community health workers (CHWs) trained in smoking cessation and motivational interviewing provide 6 weeks of supportive follow up counseling. The investigators propose a pilot of the intervention package in the Tobacco Treatment and Lung Cancer Screening Clinic (TTLCSC) at Johns Hopkins Hospital, and the Johns Hopkins Broadway Center for Addiction, assessing feasibility and acceptability of using this tool in these clinical settings. In addition, the investigators will compare whether the use of a virtual counselor is associated with greater satisfaction and engagement with the program. To this end, the investigators propose a two-arm randomized controlled trial, randomizing up to 90 individuals with tobacco use to the current CRAVEN program which includes a virtual counselor, to CRAVEN without a virtual counselor. Primary outcomes include intervention feasibility and acceptability. The investigators will secondarily examine uptake and maintenance of pharmacotherapy for tobacco cessation, readiness to quit smoking, and tobacco cessation (7 day abstinence) at 6 months, patient satisfaction by intervention arm and CHW engagement by intervention arm.

Official Title
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Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: C-Raven with avatar
* Behavioral: C-Raven without avatar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years of age receiving care in one of the two specified clinics Current daily smoker and has smoked >100 cigarettes in their lifetime English speaking Cognitively able to understand proposed research design Exclusion Criteria: Actively psychotic or other severe mental health symptoms Any contraindication to NRT use Hearing impaired (unable to listen to audio component of intervention)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-Raven + Avatar<br>Computer delivered intervention with Avatar as virtual counselor plus linkage to community health worker | Behavioral: C-Raven with avatar<br>* Computer delivered intervention with the investigators' avatar; with linkage to community health worker.<br>|
| Active Comparator: C-Raven<br>Computer-delivered intervention without virtual counselor, with linkage to community health worker | Behavioral: C-Raven without avatar<br>* Computer delivered intervention without the investigators' avatar; with linkage to community health worker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of persons agreeing to participate among those referred | Feasibility will be assessed with percent of persons agreeing to participate among those referred. | 3 months | 
| Percent of contacts made with community health worker | Implementation will be assessed with percent of contacts made with community health worker. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readiness to quit smoking as assessed by a visual analog scale | A visual analog scale of 0-100 with 0 indicating not ready to change and 100 indicating ready to change. | Immediately post intervention | 
| Uptake of pharmacotherapy as assessed by a yes/no response | Any uptake of nicotine replacement therapy or varenicline or wellbutrin. Dichotomous yes/no response will be collected. | 3 months | 
| Smoking cessation as assessed by 7-day no tobacco use self report | 7 day point prevalence abstinence. No tobacco use for 7 days by self report - yes/no. | 3 months |