Clinical trial NCT02721082: Changing the Default for Tobacco Treatment
Official title: Changing the Default for Tobacco Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use Cessation
Keywords: tobacco treatment
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-day Point-prevalence Abstinence
timeFrame: Month 1
Secondary outcomes:
measure: Treatment Engagement
timeFrame: Month 1
measure: Default-theory Based Measures
timeFrame: Month 1
measure: 7-day Point-prevalence Abstinence
timeFrame: Month 6
Other outcomes:
measure: Cost-effectiveness
timeFrame: Month 6
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kimber Richter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.