Changing the Default for Tobacco Treatment

Tobacco Use Cessation Clinical Trial

Official title:

Changing the Default for Tobacco Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721082
• Other study ID #: STUDY00001774
• Secondary ID: R01HL131512
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: December 9, 2020

Study information

• Verified date: November 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 9, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness	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.	Month 6
Primary	7-day Point-prevalence Abstinence	7-day, self-reported and verified cigarette abstinence.	Month 1
Secondary	Treatment Engagement	Percentages of participants who use cessation medications and participate in counseling post discharge	Month 1
Secondary	Default-theory Based Measures	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.	Month 1
Secondary	7-day Point-prevalence Abstinence	7-day, self-reported and verified cigarette abstinence.	Month 6