ClinicalTrials.gg
CompletedNCT04601870Updated Jan 25, 2023Results posted

Financial Incentives for Smoking Cessation Treatment Engagement

An interventional study of No Financial Incentive and Financial Incentive (100 dollars) in Quitting Smoking, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Quitting Smoking

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Keywords

  • smoking cessation
  • financial incentives
03

In context

Smoking Cessation

350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.

This study's enrollment of 98 is below the median of 150 across 326 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    No Financial Incentive

    N=180 participants randomized to not be offered monetary incentive to participate in an intervention to quit smoking.

    Other: No Financial Incentive

  • Experimental
    Financial Incentive (100 dollars)

    N=180 randomized participants will be offered a 100 dollar incentive to participate in an intervention to quit smoking.

    Other: Financial Incentive (100 dollars)

  • Experimental
    Financial Incentive (50 dollars)

    N=180 randomized participants will be offered a 50 dollar incentive to participant in an intervention to quit smoking.

    Other: Financial Incentive (50 dollars)

Interventions

  • OtherNo Financial Incentive

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

  • OtherFinancial Incentive (100 dollars)

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

  • OtherFinancial Incentive (50 dollars)

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: up to 60 days from enrollment

Other outcomes

  1. 6 Month Smoking Abstinence Rates

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

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

07

Results

Posted Jan 25, 2023

Participant flow

Participant flow — Overall Study
MilestoneNo Financial IncentiveFinancial Incentive (100 Dollars)Financial Incentive (50 Dollars)
Started383030
Completed383030
Not completed000

Outcome measures

PrimaryNumber 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.

Time frame:
up to 60 days from enrollment
Reported as:
Count of participants · Participants
Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling
ParticipantsNo Financial IncentiveFinancial Incentive (100 Dollars)Financial Incentive (50 Dollars)
Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling141414
Statistical analysis
  • No Financial Incentive vs Financial Incentive (50 Dollars) · Chi-squared · p = 0.4137 · Odds ratio (or): 1.5 · 95% CI .566 to 3.973Odds ratio for completing counseling in $50 arm vs. $0 arm
  • No Financial Incentive vs Financial Incentive (100 Dollars) · Chi-squared · p = 0.4137 · Odds ratio (or): 1.5 · 95% CI .566 to 3.973Odds ratio for completing counseling in $100 arm vs. $0 arm
  • No Financial Incentive vs Financial Incentive (100 Dollars) vs Financial Incentive (50 Dollars) · Chi-squared · p = .3383 · Odds ratio (or): 1.5 · 95% CI .653 to 3.446Odds ratio for completing counseling in $50 or $100 arm vs. $0 arm
Other pre-specified6 Month Smoking Abstinence Rates

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

Time frame:
Biochemical confirmation of abstinence occurred within 1-9 days following completion of 6-month post quit date follow-up.
Reported as:
Count of participants · Participants
6 Month Smoking Abstinence Rates
ParticipantsNo Financial IncentiveFinancial Incentive (100 Dollars)Financial Incentive (50 Dollars)
6 Month Smoking Abstinence Rates352
Statistical analysis
  • No Financial Incentive vs Financial Incentive (50 Dollars) · Chi-squared · p = .2650 · Odds ratio (or): 2.333 · 95% CI .5100 to 10.6751Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 arm vs. $0 arm
  • No Financial Incentive vs Financial Incentive (100 Dollars) · Chi-squared · p = .8472 · Odds ratio (or): .8333 · 95% CI .1301 to 5.3369Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $0 arm
  • No Financial Incentive vs Financial Incentive (100 Dollars) vs Financial Incentive (50 Dollars) · Chi-squared · p = .5478 · Odds ratio (or): 1.541 · 95% CI .3731 to 6.3640Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 or $100 arms vs. $0 arm
  • Financial Incentive (100 Dollars) vs Financial Incentive (50 Dollars) · Chi-squared · p = .2276 · Odds ratio (or): .3571 · 95% CI .06355 to 2.0070Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $50 arm

Adverse events

Collected over 6 Months Post-Target Quit Date (up to 7 months on study). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
No Financial Incentive0/38 (0%)0/38 (0%)0/38 (0%)
Financial Incentive (100 Dollars)0/30 (0%)0/30 (0%)0/30 (0%)
Financial Incentive (50 Dollars)0/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)No Financial IncentiveFinancial Incentive (100 Dollars)Financial Incentive (50 Dollars)Total
<=18 years0000
Between 18 and 65 years38303098
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)No Financial IncentiveFinancial Incentive (100 Dollars)Financial Incentive (50 Dollars)Total
Female17121746
Male21181352
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)No Financial IncentiveFinancial Incentive (100 Dollars)Financial Incentive (50 Dollars)Total
White21171553
Other than White14121339
Unknown3126
08

Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53711, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 6, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 12 months after publication of primary outcomes, and ending 5 years after that date.

Access criteria: Proposals should be directed to [PI Michael Fiore, MD at UW-CTRI (mcf@ctri.wisc.edu)]. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2021 to primary completion in Dec 2021, 10 months.

Results were first posted in Jan 2023, 1 year 1 month after primary completion.

Of 187 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 10 months is below that.

Counting every sponsor, half of 190 studies reached it within 35 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2020
First posted
Oct 26, 2020
StartActual
Feb 19, 2021
Primary completionActual
Dec 23, 2021
CompletionActual
Jun 17, 2022
Results first posted
Jan 25, 2023
Last update
Jan 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04601870
Responsible party
Sponsor
First posted
Oct 26, 2020
Start date
Feb 19, 2021
Primary completion
Dec 23, 2021
Completion
Jun 17, 2022
Results posted
Jan 25, 2023
Last update
Jan 25, 2023

Study contacts

Michael C Fiore, MD, MPH, MBA
principal investigator · University of Wisconsin, Madison

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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