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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02721082
Other study ID # STUDY00001774
Secondary ID R01HL131512
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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