Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes

• ClinicalTrials.gov Identifier: NCT03575468
• Recruitment Status: Completed
• First Posted: July 2, 2018
• Results First Posted: September 10, 2022
• Last Update Posted: October 16, 2023
• Sponsor: Consumer Wellness Solutions
• Collaborators: University of Oklahoma; SRI International; H. Lee Moffitt Cancer Center and Research Institute
• Information provided by (Responsible Party): Consumer Wellness Solutions

Study Description

Brief Summary:

The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: Enhanced E-cigarette Coaching; Behavioral: Quitline treatment as usual	Not Applicable

Detailed Description:

The specific aims of this research are to:

1. Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention.
2. Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids.
3. Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
• Actual Study Start Date: May 7, 2018
• Actual Primary Completion Date: August 31, 2020
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Enhanced E-cigarette Coaching (EEC); The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.	Behavioral: Enhanced E-cigarette Coaching; The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.; Other Name: EEC
Active Comparator: Quitline treatment as usual (TAU); The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.	Behavioral: Quitline treatment as usual; The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.; Other Name: TAU

Outcome Measures

Primary Outcome Measures :

1. Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied) [ Time Frame: 3 months after baseline ]
   In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond "I don't know" or "I prefer not to answer". On scale 1-6, 1 is the best outcome.
2. Treatment Engagement: Call Completion [ Time Frame: Phase 2 time frame: 3 months after baseline ]
   In Phase 2, call completion (captured via standard quitline data systems) will be compared for EEC and TAU participants. There is no limit to number of calls that can be completed, although participants are called to complete 5 scheduled calls (best outcome).

Secondary Outcome Measures :

1. Quit Plan Development Experience [ Time Frame: 3 months after baseline ]
   In Phase 2, quit plan development experience will be compared for EEC and TAU participants. Quit plan development experience will be measured with an adapted version of the CollaboRATE (not an abbreviation) shared decision making assessment measure. The adapted CollaboRATE measure included 3 questions (on a 5-point scale from "no effort (0)" to "every effort was made (4)"): "How much effort was made to help you understand your options for quitting smoking?", "How much effort was made to listen to the things that matter most to you about your plan for quitting smoking?", and "How much effort was made to include what matters most to you in creating your plan for quitting smoking?". Higher total scores indicate greater utilization of a shared decision-making approach during quit plan development. Scale minimum equals 0 and maximum equals 12.
2. Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes [ Time Frame: Phase 2 time frame: 3 months after baseline ]
   In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of ENDS and cigarettes, the following question was asked, "Compared to cigarettes, how harmful are e-cigarettes to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
3. Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes [ Time Frame: Phase 2 time frame: 3 months after baseline ]
   In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and cigarettes, the following question was asked, "Compared to cigarettes, how harmful are quit medications like the nicotine patch to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
4. Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS [ Time Frame: Phase 2 time frame: 3 months after baseline ]
   In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and ENDS, the following question was asked, "Compared to quit medications like the nicotine patch, how harmful are e-cigarettes to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.

Other Outcome Measures:

1. 7-Day Point Prevalence Smoking Cessation Rates [ Time Frame: Phase 2 time frame: 3 months after baseline ]
   In Phase 2 participants will report their quit status during their outcome survey.
2. Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes [ Time Frame: Up to 12 weeks ]
   A descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program

  • Currently using e-cigarettes
  • Indicated plan to use e-cigarettes in the next 30 days
  • English Speaking
  • 18+ years old
  • Willing to quit cigarettes in the next 30 days
  • Consented to receive automated phone outreach via the quitline (TCPA consented)
  • Has an Android smartphone with an operating system of 6.0 or higher and comfort downloading and using apps on phone
  • Has regular access to email
  • Callback best time between the hours of 6:00 am - 3:00 pm Pacific Standard Time

Exclusion Criteria:

• • Pregnant or Planning pregnancy within 3 months

  • Reported Schizophrenia diagnosis history during registration
  • Heart attack past 2 weeks
  • Stroke/Transient Ischemic Attack past 2 weeks
  • Rapid Irregular heart beat past 6 months
  • Angina or heart pain past 6 months
  • Currently taking Varenicline (also known as Chantix) or Bupropion (also known as Wellbutrin or Zyban)
  • Previously screened for study
  • Enrolled via proxy (i.e., did not self-enroll)

Contacts and Locations

Locations

United States, Washington

Optum

Seattle, Washington, United States, 98104

Sponsors and Collaborators

Consumer Wellness Solutions

University of Oklahoma

SRI International

H. Lee Moffitt Cancer Center and Research Institute

Investigators

• Principal Investigator: Katrina Vickerman, PHD; Optum, Inc.

  Study Documents (Full-Text)

Documents provided by Consumer Wellness Solutions:

Study Protocol  [PDF] March 7, 2018

Statistical Analysis Plan  [PDF] November 9, 2016

More Information

Publications of Results:

Vickerman KA, Carpenter KM, Miles LN, Hsu JM, Watt KA, Brandon TH, Hart JT, Javitz HS, Wagener TL. Treatment development, implementation, and participant baseline characteristics: A randomized pilot study of a tailored quitline intervention for individuals who smoke and vape. Contemp Clin Trials Commun. 2021 Sep 8;24:100845. doi: 10.1016/j.conctc.2021.100845. eCollection 2021 Dec.

• Responsible Party: Consumer Wellness Solutions
• ClinicalTrials.gov Identifier: NCT03575468
• Other Study ID Numbers: 1R21DA042960-01A1 ( U.S. NIH Grant/Contract )
• First Posted: July 2, 2018
• Results First Posted: September 10, 2022
• Last Update Posted: October 16, 2023
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Consumer Wellness Solutions:

e-cigarette; vaping; electronic nicotine delivery system (ENDS); smoking cessation