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OpenTrials
Completed

NCT Number: NCT04601870

Financial Incentives for Smoking Cessation Treatment Engagement

This study is being done to see if financial incentives increase the rate at which smokers engage in cessation treatment. A total of 540 participants will be enrolled by invitation from 6 primary care clinics of the participating healthcare system. Participants will be in the study for approximately 28 weeks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53711, United States

About this study

In this randomized controlled trial, each patient of participating Group Health Cooperative of South Central Wisconsin (GHC-SCW) primary care clinics who is listed in the Cigarette User Registry receiving standard telephone contact from their GHC-SCW Tobacco Cessation Outreach Specialist (TCOS) to discuss tobacco use treatment options will be reminded of GHC-SCW's commitment to helping them improve their health, advised to quit smoking, offered support to quit smoking, recruited, screened, consented, and randomized over the phone to one of three conditions of financial engagement incentives. Smokers unwilling to participate in the incentivized treatment program will be offered entry into the existing GHC-SCW standard smoking cessation program. Participants in the research study will also receive smoking treatment via the existing GHC-SCW standard smoking cessation program. Participants in the research study will be told that they may receive a treatment engagement incentive, with the amount consistent with their randomized incentive condition; receipt of their assigned incentive amount is dependent upon their setting a quit date and completing two smoking cessation treatment counseling contacts. The smoking cessation treatment includes medication and 3 quit smoking counseling calls scheduled to occur after the recruitment contact call, which is the standard smoking cessation program available to all GHC-SCW patients. This program entails a brief counseling call a week (typically 5-7 days) pre-quit i.e., before the patient's target quit date (TQD), approximately 5-7 days following the TQD (Week 1), and about one month following the TQD (Week 4).

Research participants will be asked to complete brief (3 to 5 minute) assessments during each standard care smoking treatment counseling call by GHC-SCW, plus 15-25 minute research study phone interviews 3- and 6-months post-TQD for study purposes. Those claiming abstinence at the 6-month post-TQD phone interview will be asked to return to their primary care clinic to complete breath, urine, and/or saliva testing to verify abstinence from combustible tobacco. This will entail providing breath samples for carbon monoxide testing and/or a urine or saliva sample for immediate cotinine testing (no samples will be stored). Participants may also be asked to collect a saliva sample at home and return it in the mail if they do not attend a biochemical verification visit.

Primary Aims:

  • To determine the relations between treatment engagement financial incentive amounts offered and likelihood of patient engagement in smoking cessation treatment.
  • Primary outcome measure: Patient engagement in smoking cessation treatment (defined as setting a TQD and completing two phone counseling calls).

Exploratory Aims

  • Conduct exploratory analyses on the effects of the different incentive engagement amounts on biochemically confirmed point-prevalence abstinence 6 months post-quit-date, and determine whether incentive condition affects abstinence via effects on smoking treatment engagement (i.e., whether smoking treatment engagement mediates the relations between different engagement incentive conditions and 6-month smoking abstinence).
  • To determine the incremental cost-effectiveness of the different financial engagement incentive amounts with regard to total program costs vs. usual care, net monetary benefit (NMB), cost per quit, and incremental cost-effectiveness ratios (ICERs), with the last determined with regard to cost of additional smoker recruited and each additional individual who quits smoking.
  • To determine the representativeness of smoking treatment reach and smoking abstinence outcomes generated by the various engagement incentive amounts with regard to different groups of smokers: e.g., those low in socio-economic status, priority populations, different racial and ethnic groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On Cigarette User Registry at a participating clinic
  • Able to speak English or Spanish

Exclusion criteria

  • Activated healthcare power of attorney or cognitive impairment that would preclude informed consent.
  • Existing target quit date approximately 30 days from date of call to TCOS
  • Current billable insurance status in EHR of Medicare or non-BadgerCare Medicaid
  • Prior screening for Treatment Engagement incentive enrollment

Treatment and study plan

No Financial Incentive

Other

No monetary incentive to participate in quit planning and quit counseling with a tobacco cessation specialist.

Financial Incentive (100 dollars)

Other

Financial incentive (100 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.

Financial Incentive (50 dollars)

Other

Financial incentive (50 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.

Primary outcomes

  1. Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling

    Time frame: up to 60 days from enrollment

    The relation between treatment engagement financial incentive amounts offered and likelihood of patient engagement in smoking cessation treatment will be assessed by the number of participants who set a TQD and complete two phone counseling calls.

Other outcomes

  1. 6 Month Smoking Abstinence Rates

    Time frame: Biochemical confirmation of abstinence occurred within 1-9 days following completion of 6-month post quit date follow-up.

    Exploratory analysis on the effects of the different incentive engagement amounts on biochemically confirmed abstinence 6-month post quit date.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized Test of Financial Incentives for Smoking Cessation Treatment Engagement Among A Healthcare System's Universal Primary Care Population

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 26, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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