MedPath

Changing the Default for Tobacco Treatment

Phase 4
Completed
Conditions
Tobacco Use Cessation
Interventions
Behavioral: Opt In Treatment Program
Behavioral: Opt Out Treatment Program
Registration Number
NCT02721082
Lead Sponsor
University of Kansas Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1000
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Opt OutNicotine Replacement TherapyParticipants 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.
Opt InOpt In Treatment ProgramTraditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt OutOpt Out Treatment ProgramParticipants 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.
Opt InNicotine Replacement TherapyTraditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Primary Outcome Measures
NameTimeMethod
7-day Point-prevalence AbstinenceMonth 1

7-day, self-reported and verified cigarette abstinence.

Secondary Outcome Measures
NameTimeMethod
Treatment EngagementMonth 1

Percentages of participants who use cessation medications and participate in counseling post discharge

7-day Point-prevalence AbstinenceMonth 6

7-day, self-reported and verified cigarette abstinence.

Default-theory Based MeasuresMonth 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.

Trial Locations

Locations (1)

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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