Clinical trial NCT05145738: Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study
Official title: Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percent of persons agreeing to participate among those referred
timeFrame: 3 months
measure: Percent of contacts made with community health worker
timeFrame: 3 months
Secondary outcomes:
measure: Readiness to quit smoking as assessed by a visual analog scale
timeFrame: Immediately post intervention
measure: Uptake of pharmacotherapy as assessed by a yes/no response
timeFrame: 3 months
measure: Smoking cessation as assessed by 7-day no tobacco use self report
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Tobacco Treatment Clinic at Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Geetanjali Chander
role: PRINCIPAL_INVESTIGATOR
References: