SmokingNCT02713594
Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation
A study testing Counseling from WTQL and Financial incentive to participate in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation, Nicotine Dependence
- What is being tested?
- Counseling from WTQL and Financial incentive to participate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,900 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Mar 2017
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Wisconsin Tobacco Quit Line Centers for Medicaid Services Striving To Quit Evaluation Project
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.
Read the 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).
- Conditions
- Smoking, Smoking Cessation, Nicotine Dependence
- Being tested
- Counseling from WTQL, Financial incentive to participate
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling from WTQLBehavioural
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.
Financial incentive to participateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Counseling from WTQL Receives: Behavioral: Counseling from WTQL |
| Incentive | Experimental | Counseling from WTQL; Financial incentive to participate Receives: Behavioral: Counseling from WTQL; Other: Financial incentive to participate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence From Smoking
The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).
Measured: Measured 6 months after enrollment at follow-up assessment
Secondary outcomes (2)
Engagement in Treatment
This analysis will compare number of calls completed
Measured: Measured 6 months after enrollment at follow-up assessment
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.
Measured: Measured 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startApr 2013
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy b Baker, PhD, Principal investigator, University of Wisconsin--CTRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713594
- Sponsor's protocol ID
- 2013-0056 (400025710)
- Status last verified
- Apr 2017
- First submitted
- 16 Feb 2016
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fraser DL, Fiore MC, Kobinsky K, Adsit R, Smith SS, Johnson ML, Baker TB. A Randomized Trial of Incentives for Smoking Treatment in Medicaid Members. Am J Prev Med. 2017 Dec;53(6):754-763. doi: 10.1016/j.amepre.2017.08.027. Epub 2017 Nov 2.
PubMed 29079405
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wisconsin Tobacco Quit Line Centers for Medicaid Services Striving To Quit Evaluation Project
- ClinicalTrials.gov ID
- NCT02713594
- Acronym / sponsor ID
- 2013-0056 (400025710)
- Conditions
- Smoking, Smoking Cessation, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Counseling from WTQLCounseling from WTQL |
| Incentive | Experimental | Behavioral: Counseling from WTQL, Other: Financial incentive to participateCounseling from WTQL; Financial incentive to participate |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling from WTQLCounseling 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. | Behavioural | Control, Incentive |
| Financial incentive to participateParticipants 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. | Other | Incentive |
Primary outcome
Abstinence From Smoking
Time frame: 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).
2 secondary outcomes
Engagement in Treatment
Time frame: Measured 6 months after enrollment at follow-up assessment
Cost-effectiveness
Time frame: Measured 6 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29079405Fraser DL, Fiore MC, Kobinsky K, Adsit R, Smith SS, Johnson ML, Baker TB. A Randomized Trial of Incentives for Smoking Treatment in Medicaid Members. Am J Prev Med. 2017 Dec;53(6):754-763. doi: 10.1016/j.amepre.2017.08.027. Epub 2017 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy b Baker, PhD principal investigator
University of Wisconsin--CTRI
Questions about this trial
What is this clinical trial studying?
A study testing Counseling from WTQL and Financial incentive to participate in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison.
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 7 inclusion and 7 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 21 Apr 2017). 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?
Abstinence From Smoking (time frame: Measured 6 months after enrollment at follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713594, which also lists 1 linked publication.
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 21 Apr 2017.