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Completed

NCT Number: NCT02721082

Changing the Default for Tobacco Treatment

The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care.

For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit.

This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Speak English or Spanish
  • Have access to a telephone or mobile phone
  • Not be currently pregnant or breast feeding
  • Have no significant co-morbidity that precludes participation
  • Current daily smoker
  • Not in treatment for tobacco dependence
  • Reside in Kansas or Missouri

Exclusion criteria

  • Admission greater than 3 days

Treatment and study plan

Opt Out Treatment Program

Behavioral

Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.

Nicotine Replacement Therapy

Drug

Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.

Other names: Nicotine patch, Nicotine mini-lozenges, Nicotine gum

Opt In Treatment Program

Behavioral

Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.

Primary outcomes

  1. 7-day Point-prevalence Abstinence

    Time frame: Month 1

    7-day, self-reported and verified cigarette abstinence.

Secondary outcomes

  1. Treatment Engagement

    Time frame: Month 1

    Percentages of participants who use cessation medications and participate in counseling post discharge

  2. Default-theory Based Measures

    Time frame: Month 1

    We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form.

  3. 7-day Point-prevalence Abstinence

    Time frame: Month 6

    7-day, self-reported and verified cigarette abstinence.

Other outcomes

  1. Cost-effectiveness

    Time frame: Month 6

    Counselor time, wage estimates, pharmacotherapy costs, and abstinence rates will be combined to report the incremental cost-effective ratio (ICER). The ICER is the ratio of the difference in costs divided by the difference in effectiveness between the two study arms. ICER indicates the added cost per additional quitter, a metric that will allow comparisons to other smoking cessation economic studies.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 28, 2016
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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