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
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.
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.
Exploratory Aims
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 →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.
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.
Exclusion Criteria:
N=180 participants randomized to not be offered monetary incentive to participate in an intervention to quit smoking.
Other: No Financial Incentive
N=180 randomized participants will be offered a 100 dollar incentive to participate in an intervention to quit smoking.
Other: Financial Incentive (100 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)
No monetary incentive to participate in quit planning and quit counseling with a tobacco cessation specialist.
Financial incentive (100 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.
Financial incentive (50 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.
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
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.
| Milestone | No Financial Incentive | Financial Incentive (100 Dollars) | Financial Incentive (50 Dollars) |
|---|---|---|---|
| Started | 38 | 30 | 30 |
| Completed | 38 | 30 | 30 |
| Not completed | 0 | 0 | 0 |
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.
| Participants | No Financial Incentive | Financial Incentive (100 Dollars) | Financial Incentive (50 Dollars) |
|---|---|---|---|
| Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling | 14 | 14 | 14 |
Exploratory analysis on the effects of the different incentive engagement amounts on biochemically confirmed abstinence 6-month post quit date.
| Participants | No Financial Incentive | Financial Incentive (100 Dollars) | Financial Incentive (50 Dollars) |
|---|---|---|---|
| 6 Month Smoking Abstinence Rates | 3 | 5 | 2 |
Collected over 6 Months Post-Target Quit Date (up to 7 months on study). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Financial Incentive | 0/38 (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%) |
| Age, Categorical(Participants) | No Financial Incentive | Financial Incentive (100 Dollars) | Financial Incentive (50 Dollars) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 38 | 30 | 30 | 98 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | No Financial Incentive | Financial Incentive (100 Dollars) | Financial Incentive (50 Dollars) | Total |
|---|---|---|---|---|
| Female | 17 | 12 | 17 | 46 |
| Male | 21 | 18 | 13 | 52 |
| Race/Ethnicity, Customized(Participants) | No Financial Incentive | Financial Incentive (100 Dollars) | Financial Incentive (50 Dollars) | Total |
|---|---|---|---|---|
| White | 21 | 17 | 15 | 53 |
| Other than White | 14 | 12 | 13 | 39 |
| Unknown | 3 | 1 | 2 | 6 |
Documents are hosted by the registry — open the source record to download them.
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.
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.
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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