Changing the Default for Tobacco Treatment

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.

• Opt Out Treatment Program (Behavioral): Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
• Nicotine Replacement Therapy (Drug), also known as Nicotine patch, Nicotine mini-lozenges, Nicotine gum: 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.
• 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.
• Nicotine Replacement Therapy (Drug), also known as Nicotine patch, Nicotine mini-lozenges, Nicotine gum: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.

Primary outcomes

• 7-day Point-prevalence Abstinence [Month 1]: 7-day, self-reported and verified cigarette abstinence.

Secondary outcomes

• Treatment Engagement [Month 1]: Percentages of participants who use cessation medications and participate in counseling post discharge
• Default-theory Based Measures [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.
• 7-day Point-prevalence Abstinence [Month 6]: 7-day, self-reported and verified cigarette abstinence.

Other outcomes

• Cost-effectiveness [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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• 7-day Point-prevalence Abstinence (Primary), Mean, Percentage of participants quit at 1-mo: Opt Out 21.5 (17.9 to 25.4); Opt In 15.8 (11.8 to 20.5)
• Treatment Engagement (Secondary), Mean, Percentage of participants w/script: Opt Out 87.68 (84.50 to 90.54); Opt In 37.84 (32.18 to 43.75)
• Default-theory Based Measures (Secondary), Mean, % felt they had control over quitting: Opt Out 88.41 (85.19 to 91.28); Opt In 86.64 (82.07 to 90.63)
• 7-day Point-prevalence Abstinence (Secondary), Mean, Percentage of participants quit at 6-mo: Opt Out 18.57 (15.0 to 22.4); Opt In 17.90 (13.2 to 23.1)
• Cost-effectiveness (Other pre specified)

Adverse events

Time frame: Adverse event data were collect for 6 months following randomization

Serious adverse events by term

• Results publication: Richter KP, Catley D, Gajewski BJ, Faseru B, Shireman TI, Zhang C, Scheuermann TS, Mussulman LM, Nazir N, Hutcheson T, Shergina E, Ellerbeck EF. The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial. JAMA Intern Med. 2023 Apr 1;183(4):331-339. doi: 10.1001/jamainternmed.2022.7170. PMID 36848129
• Results publication: Faseru B, Mussulman LM, Nazir N, Ellerbeck EF, Shergina E, Scheuermann TS, Gajewski BJ, Catley D, Richter KP. Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment. Subst Abus. 2022;43(1):1035-1042. doi: 10.1080/08897077.2022.2060441. PMID 35435813
• Results publication: Faseru B, Ellerbeck EF, Catley D, Gajewski BJ, Scheuermann TS, Shireman TI, Mussulman LM, Nazir N, Bush T, Richter KP. Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials. 2017 Aug 14;18(1):379. doi: 10.1186/s13063-017-2119-9. PMID 28806908

• Study Protocol (PDF, 2021-10-01)
• Statistical Analysis Plan (PDF, 2021-10-01)

• Kimber Richter, PhD, Principal investigator, University of Kansas Medical Center

NIH grants: R01HL131512