Nicotine Dependence, Smoking, Smoking Cessation
Conditions
Brief summary
The study is designed to test the hypotheses that financial incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to BadgerCare Plus (Medicaid) smokers as part of their health care.
Detailed description
Previous research on providing incentives for healthy behaviors has shown that financial incentives can increase treatment participation and boost outcomes when they are tied to participation in evidence based treatments. However, most of this research has been done in laboratory settings and in relatively small clinical trials. This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Wisconsin BadgerCare Plus (Medicaid) smokers as part of their health care. If successful, this treatment approach could be used more broadly to reduce the considerable financial and personal costs associated with smoking-related disease. In this study, Medicaid-eligible smokers were recruited from primary care clinics and from callers to the Wisconsin Tobacco Quit Line (WTQL) with randomization a Control condition and an Incentive condition. All participants were offered five cessation calls from the WTQL and participants were encouraged by WTQL coaches to obtain cessation medication from their primary care providers. All participants received payment for completing a baseline assessment ($40) and a 6-month smoking test ($40). Only Incentive condition participants received additional compensation for taking counseling calls ($30 per completed call) and for biochemically-verified abstinence at the 6-month visit ($40).
Interventions
BEHAVIORALCounseling from WTQL
Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
OTHERFinancial incentive to participate
Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.) Compensation was in the form of prepaid Visa gift cards mailed approximately 2-4 weeks after the point of contact.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* enrollment in Wisconsin Medicaid (BadgerCare Plus) * resides in study area (one of 25 counties) * 18 or older * English or Spanish speaking * has smoked daily (at least 5 cigarettes each day) over the last week * willingness to attend visits at his/her PCC (primary care clinic) or go to a testing site at baseline and 6 months (2 times over a 6 month period), provide urine samples or participate in exhaled carbon monoxide testing, and complete follow-up phone calls from the WTQL * willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.
Exclusion criteria
* not enrolled in Wisconsin Medicaid (BadgerCare Plus) * not reside in study area * less than 18 years of age * not English or Spanish speaking * does not smoke daily (at least 5 cigarettes each day) over the last week * not willing to attend visits at his/her PCC (primary care clinic) or alternative testing site at baseline and 6 months (2 times over a 6 month period), provide urine or exhaled carbon monoxide samples, and complete follow-up phone calls. * not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence From Smoking | Measured 6 months after enrollment at follow-up assessment | The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Treatment | Measured 6 months after enrollment at follow-up assessment | This analysis will compare number of calls completed |
| Cost-effectiveness | Measured 6 months after enrollment | This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Counseling from WTQL | 952 |
| Incentive Counseling from WTQL; Financial incentive to participate | 948 |
| Total | 1,900 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 358 | 374 |
| Overall Study | Withdrawal by Subject | 32 | 22 |
Baseline characteristics
| Characteristic | Control | Total | Incentive |
|---|---|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 11.2 | 45.0 years STANDARD_DEVIATION 11.2 | 45.0 years STANDARD_DEVIATION 11.2 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 18 Participants | 34 Participants | 16 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 487 Participants | 972 Participants | 485 Participants |
| Race/Ethnicity, Customized Other | 36 Participants | 74 Participants | 38 Participants |
| Race/Ethnicity, Customized Refused/Do not know/Not collected | 18 Participants | 33 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 390 Participants | 783 Participants | 393 Participants |
| Region of Enrollment United States | 952 Count of Participants | 1900 Count of Participants | 948 Count of Participants |
| Sex: Female, Male Female | 577 Participants | 1146 Participants | 569 Participants |
| Sex: Female, Male Male | 375 Participants | 754 Participants | 379 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Abstinence From Smoking
The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).
Time frame: Measured 6 months after enrollment at follow-up assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Abstinence From Smoking | 131 Participants |
| Incentive | Abstinence From Smoking | 205 Participants |
p-value: <0.000195% CI: [-11.28, -4.5]Abstinence Risk Difference
Secondary
Cost-effectiveness
This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.
Time frame: Measured 6 months after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Cost-effectiveness | 5193 U.S. Dollars |
| Incentive | Cost-effectiveness | 4108 U.S. Dollars |
Secondary
Engagement in Treatment
This analysis will compare number of calls completed
Time frame: Measured 6 months after enrollment at follow-up assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Engagement in Treatment | 1 Call Taken | 245 Participants |
| Control | Engagement in Treatment | 3 Calls Taken | 154 Participants |
| Control | Engagement in Treatment | Zero Calls Taken | 6 Participants |
| Control | Engagement in Treatment | 4 Calls Taken | 165 Participants |
| Control | Engagement in Treatment | 2 Calls Taken | 179 Participants |
| Control | Engagement in Treatment | 5 Calls Taken | 203 Participants |
| Incentive | Engagement in Treatment | 2 Calls Taken | 113 Participants |
| Incentive | Engagement in Treatment | Zero Calls Taken | 3 Participants |
| Incentive | Engagement in Treatment | 1 Call Taken | 76 Participants |
| Incentive | Engagement in Treatment | 5 Calls Taken | 435 Participants |
| Incentive | Engagement in Treatment | 3 Calls Taken | 122 Participants |
| Incentive | Engagement in Treatment | 4 Calls Taken | 199 Participants |
p-value: <0.0001Chi-squared