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Financial Incentives for Smoking Cessation Treatment Engagement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04601870
Enrollment
98
Registered
2020-10-26
Start date
2021-02-19
Completion date
2022-06-17
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quitting Smoking

Keywords

smoking cessation, financial incentives

Brief 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.

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.

Interventions

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counselingup to 60 days from enrollmentThe 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

MeasureTime frameDescription
6 Month Smoking Abstinence RatesBiochemical 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
No Financial Incentive
N=180 participants randomized to not be offered monetary incentive to participate in an intervention to quit smoking. No Financial Incentive: No monetary incentive to participate in quit planning and quit counseling with a tobacco cessation specialist.
38
Financial Incentive (100 Dollars)
N=180 randomized participants will be offered a 100 dollar incentive to participate in an intervention to quit smoking. Financial Incentive (100 dollars): Financial incentive (100 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.
30
Financial Incentive (50 Dollars)
N=180 randomized participants will be offered a 50 dollar incentive to participant in an intervention to quit smoking. Financial Incentive (50 dollars): Financial incentive (50 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.
30
Total98

Baseline characteristics

CharacteristicFinancial Incentive (100 Dollars)Financial Incentive (50 Dollars)TotalNo Financial Incentive
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants30 Participants98 Participants38 Participants
Race/Ethnicity, Customized
Other than White
12 Participants13 Participants39 Participants14 Participants
Race/Ethnicity, Customized
Unknown
1 Participants2 Participants6 Participants3 Participants
Race/Ethnicity, Customized
White
17 Participants15 Participants53 Participants21 Participants
Sex: Female, Male
Female
12 Participants17 Participants46 Participants17 Participants
Sex: Female, Male
Male
18 Participants13 Participants52 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 380 / 300 / 30
other
Total, other adverse events
0 / 380 / 300 / 30
serious
Total, serious adverse events
0 / 380 / 300 / 30

Outcome results

Primary

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

Population: Intent-to-treat analysis to assess overall engagement in the study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No Financial IncentiveNumber of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling14 Participants
Financial Incentive (100 Dollars)Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling14 Participants
Financial Incentive (50 Dollars)Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling14 Participants
p-value: 0.413795% CI: [0.566, 3.973]Chi-squared
p-value: 0.413795% CI: [0.566, 3.973]Chi-squared
Comparison: $0 vs. $50 or $100p-value: 0.338395% CI: [0.653, 3.446]Chi-squared
Other Pre-specified

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.

Population: Intent-to-treat analysis to assess population-based cessation rate.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No Financial Incentive6 Month Smoking Abstinence Rates3 Participants
Financial Incentive (100 Dollars)6 Month Smoking Abstinence Rates5 Participants
Financial Incentive (50 Dollars)6 Month Smoking Abstinence Rates2 Participants
p-value: 0.26595% CI: [0.51, 10.6751]Chi-squared
p-value: 0.847295% CI: [0.1301, 5.3369]Chi-squared
Comparison: $0 vs. $50 or $100p-value: 0.547895% CI: [0.3731, 6.364]Chi-squared
p-value: 0.227695% CI: [0.06355, 2.007]Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026