Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community

Feasibility, Acceptability, and Piloting of a Virtual Counselor Tobacco Cessation Intervention With Community Health Worker Linkage to Lung Cancer Screening

To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT).

The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Dependence
• Intervention / Treatment: Behavioral: C-Raven Virtual Tobacco Cessation Counseling; Drug: Nicotine Replacement Product; Other: Community Health Worker; Other: Lung Cancer Screening

Detailed Description

In anticipation of a future two-arm type 1 hybrid effectiveness-implementation randomized controlled trial comparing a virtual counselor-led computer delivered intervention (VCTC) augmented with CHW support in low-income housing units in Baltimore City. This pilot study will generate preliminary data for a larger study. The investigators will conduct a feasibility pilot study of the entire VCTC and CHW intervention with a sample of participants (N=15) to collect data on the feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, one month, and three months. At the end of three months, the investigators will conduct follow-up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on the information collected in these efforts, the investigators will make iterative improvements to the existing intervention, aligned with user-experience design procedures.

Participants will be recruited through flyers posted in and around the housing units and distributed to tenants by housing unit staff. Flyers will describe the study and contain a study phone number to call. Information may also be distributed by study staff during non-study-related health and wellness activities conducted at the sites. At initial contact, a study staff member will discuss the study purpose and determine eligibility. If eligible, the staff member will proceed to discuss requirements, review risks and benefits, and obtain informed consent from interested participants.

Consent process: After confirming eligibility with screening questions via phone, potential participants will be offered the option of reviewing the study information and consent form over a Zoom video conference. Regardless of whether the participants choose to review this information in advance, all potential participants will complete the consent process and sign the consent form at the beginning of the first in-person visit, which will be conducted on-site at the participants housing community.

Baseline Assessment: This will occur on the same day as the in-person portion of the consent process. Initial evaluation will comprise the research assessments detailed in Table 1, including demographics, a clinical history, a tobacco use history, and a number of tobacco-related measures. Assessments will be self-administered via tablet computer.

Intervention:

Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment, participants will receive computer-delivered counseling via a study-provided iPad delivered in a private room. VCTC consists of 1) a menu-driven, web-based intervention that is delivered by a virtual counselor. The intervention takes 20 minutes to complete. At the conclusion of session 1, the participant will be offered nicotine patches provided by the study (1 month supply, remainder given at follow-up visits). The initial dosing of the nicotine patches will be determined based on cigarettes consumed per day (>10: 21mg patch, 5-10: 14mg patch, <5: 7mg patch). If there is any question regarding eligibility or appropriate dosing, the CHW will consult with a study physician. With the CHW, the participant will learn correct application, and will monitor the participants nicotine replacement therapy (NRT) experience in discussion with the CHW.

Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT, bupropion, varenicline). This intervention also takes about 20 minutes to complete. At the conclusion of session 2, the participant will be offered nicotine gum or lozenges provided by the study (1 month supply, remainder given at follow-up visits). This session also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to ensure correct use.

Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions 1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2) Follow up with patients remotely via phone or video conference whenever possible, up to twice weekly for 12 weeks, to discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 3) Review the modified lung cancer shared decision-making guide from Phase 1 and provide linkage to lung cancer screening if the participant is eligible and interested, including linkage to insurance enrollment assistance, if needed; 4) For individuals requiring follow up for positive findings on lung CT, work with participants to navigate the process; 5) Link interested participants to the QuitLine; 6) At the end of the study, link to medical providers for additional tobacco cessation therapy if participant interested (e.g., varenicline, bupropion).

Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the participants primary care physician (PCP) or existing specialist for further discussion and ordering. The CTs are optional and will not be provided as part of the research study. The CHW will assist with linking patients without a PCP or existing specialist with resources to establish care. For participants who choose to proceed with screening, the investigators will request the results of the CT scan to track completion and general result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term Follow-Up/Abnormal Needing Immediate Follow-Up).

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeanne Clark, MD; Phone Number: 4106141135; Email: jmclark@jhmi.edu
• Study Contact Backup: Name: Alejandra Ellison-Barnes, MD; Phone Number: 410-614-1135; Email: aelliso6@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University School of Medicine
      • Contact: Jeanne Clark, MD; Phone Number: 410-614-1135; Email: jmclark@jhmi.edu
      • Contact: Alejandra Ellison-Barnes, MD; Phone Number: 4106141135; Email: aelliso6@jhmi.edu
    • Baltimore, Maryland, United States, 21201
      • Chase House Apartments
      • Contact: Jeanne Clark, MD; Phone Number: 410-614-1135; Email: jmclark@jhmi.edu
      • Contact: Alejandra Ellison-Barnes, MD; Phone Number: 4106141135; Email: aelliso6@jhmi.edu
    • Baltimore, Maryland, United States, 21202
      • Monument East
      • Contact: Jeanne Clark, MD; Phone Number: 410-614-1135; Email: jmclark@jhmi.edu
      • Contact: Alejandra Ellison-Barnes, MD; Phone Number: 4106141135; Email: aelliso6@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 50 or older
• Current tobacco use with >100 cigarettes smoked in their lifetime
• English speaking (intervention currently in English only and housing units are in largely English-speaking neighborhoods)
• Considering smoking cessation
• Planning to remain in current housing unit for 6 months

Exclusion Criteria:

• Current use of pharmacological treatment for tobacco cessation
• Contraindication to nicotine replacement therapy
• Current engagement in formal smoking cessation program
• Major cognitive or psychiatric impairment
• Severe hearing impairment
• Investigator discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Smoking Cessation Intervention; Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.

Behavioral: C-Raven Virtual Tobacco Cessation Counseling; A two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete.; Drug: Nicotine Replacement Product; Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges.; Other: Community Health Worker; A community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed.; Other: Lung Cancer Screening; Eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and Feasibility	Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readiness to quit smoking as assessed by The Readiness Ruler	The Readiness Ruler is a brief measure of motivation, which prompts patients with a 10-point visual analog scale on which they rate readiness, with a score of 0 reflecting "not ready," and a score of 10 reflecting "ready."	3 months
Number of Participants that Uptake nicotine replacement therapy	Number of participants that start using NRTs during the study period	3 months
Continued use of nicotine replacement therapy	Number of participants that continue to use NRTs at 1 month and 3 months	1 month and 3 months
Number of quit attempts	Number of participants that attempt to quit, and how many quit attempts each makes during the study period	3 months
Number of participants than maintain cessation	Number of participants that have maintained cessation for at least one week prior to the assessments at 1 month and 3 months	1 month and 3 months
Number of participants that uptake Quit Line services	Number of participants that choose to utilize Quit Line services	3 months
Participant engagement with community health worker as assessed by number of CHW interactions	Frequency of interactions with CHW	3 months
Participant satisfaction as assessed by study team survey	Overall satisfaction with the intervention. This will be measured with a 19 item questionnaire which uses a 5 item Likert Scale for each question. Answers of "agree" and "strongly agree" will be evaluated across the intervention components,	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Maryland Cigarette Restitution Fund
• Investigators: Principal Investigator: Jeanne Clark, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IRB00396489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No