Changing the Default for Tobacco Treatment
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|ClinicalTrials.gov Identifier: NCT02721082|
Recruitment Status : Enrolling by invitation
First Posted : March 28, 2016
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Cessation||Behavioral: Opt Out Treatment Program Drug: Nicotine Replacement Therapy Behavioral: Opt In Treatment Program||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changing the Default for Tobacco Treatment|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Opt Out
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Behavioral: Opt Out Treatment Program
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Drug: Nicotine Replacement Therapy
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.
Active Comparator: Opt In
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Behavioral: Opt In Treatment Program
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.
Drug: Nicotine Replacement Therapy
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.
- 7-day point-prevalence abstinence [ Time Frame: 1 month ]7-day, self-reported and verified cigarette abstinence at 1 month after enrollment. Will be measured via salivary cotinine or expired carbon monoxide to confirm smoking status.
- Cost of counseling [ Time Frame: Month 1 ]Cost of counseling will be calculated based on total counseling time
- Number of days of medication use [ Time Frame: 6 months ]Measured as an aggregate of the type, dose and number of days medication was used
- Total intervention cost [ Time Frame: 6 months ]Calculation for cost will include inpatient counselor services, quit line counselor time and medication given to participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721082
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Kimber Richter, PhD||University of Kansas Medical Center|