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Quitting SmokingNCT04601870

Financial Incentives for Smoking Cessation Treatment Engagement

A study testing No Financial Incentive, Financial Incentive (100 dollars) and Financial Incentive (50 dollars) in people with Quitting Smoking, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Quitting Smoking
What is being tested?
No Financial Incentive, Financial Incentive (100 dollars) and Financial Incentive (50 dollars)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteUnited States
Study dates
19 Feb 2021to 17 Jun 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53711

Other trials in United States

About this study

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

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.

Read the detailed description

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.
Being tested
No Financial Incentive, Financial Incentive (100 dollars), Financial Incentive (50 dollars)
Keywords
smoking cessation, financial incentives
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Financial IncentiveOther

    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.

Study groups in NCT04601870
Study groupRoleWhat they receive
No Financial IncentiveExperimentalN=180 participants randomized to not be offered monetary incentive to participate in an intervention to quit smoking.
Receives: Other: No Financial Incentive
Financial Incentive (100 dollars)ExperimentalN=180 randomized participants will be offered a 100 dollar incentive to participate in an intervention to quit smoking.
Receives: Other: Financial Incentive (100 dollars)
Financial Incentive (50 dollars)ExperimentalN=180 randomized participants will be offered a 50 dollar incentive to participant in an intervention to quit smoking.
Receives: Other: Financial Incentive (50 dollars)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: up to 60 days from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start19 Feb 2021
  3. Primary completion23 Dec 2021
  4. Study completion17 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04601870
Sponsor's protocol ID
2020-0717
Other IDs
A534253, SMPH/MEDICINE/GEN INT MD, Protocol Version 1/6/2021, 3R35CA197573-06S1
Status last verified
Dec 2022
First submitted
19 Oct 2020
Last updated
25 Jan 2023
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data collected during the trial, after deidentification. Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose, for independent verification of study outcomes, or to conduct subsequent clinical research.

Questions about this trial

What is this clinical trial studying?

A study testing No Financial Incentive, Financial Incentive (100 dollars) and Financial Incentive (50 dollars) in people with Quitting Smoking, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling (time frame: up to 60 days from enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.

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