Changing the Default for Tobacco Treatment

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Opt Out Treatment Program; Drug: Nicotine Replacement Therapy; Drug: Nicotine Replacement Therapy; Behavioral: Opt In Treatment Program

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Nicotine patch; Nicotine mini-lozenges; Nicotine gum; 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.; Other Names: Nicotine patch; Nicotine mini-lozenges; Nicotine gum
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.	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.; Other Names: Nicotine patch; Nicotine mini-lozenges; Nicotine gum; 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.; Other Names: Nicotine patch; Nicotine mini-lozenges; Nicotine gum; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day Point-prevalence Abstinence	7-day, self-reported and verified cigarette abstinence.	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Engagement	Percentages of participants who use cessation medications and participate in counseling post discharge	Month 1
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
7-day Point-prevalence Abstinence	7-day, self-reported and verified cigarette abstinence.	Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Kimber Richter, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 27, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: March 25, 2016
• First Posted (Estimate): March 28, 2016

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: tobacco treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: STUDY00001774; R01HL131512 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No