Trial Outcomes & Findings for Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation (NCT NCT02713594)

NCT ID: NCT02713594

Last Updated: 2017-04-21

Results Overview

The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1900 participants

Primary outcome timeframe

Measured 6 months after enrollment at follow-up assessment

Results posted on

2017-04-21

Participant Flow

Participant milestones

Participant milestones
Measure
Control
Participants in the Control condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting 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.
Incentive
Participants in the Incentive Condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting 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. Participants in the Incentive condition also received financial incentives to complete proactive counseling calls from the WTQL received ($30 per completed call); in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit.
Overall Study
STARTED
952
948
Overall Study
COMPLETED
562
552
Overall Study
NOT COMPLETED
390
396

Reasons for withdrawal

Reasons for withdrawal
Measure
Control
Participants in the Control condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting 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.
Incentive
Participants in the Incentive Condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting 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. Participants in the Incentive condition also received financial incentives to complete proactive counseling calls from the WTQL received ($30 per completed call); in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit.
Overall Study
Withdrawal by Subject
32
22
Overall Study
Lost to Follow-up
358
374

Baseline Characteristics

Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=952 Participants
Counseling from WTQL
Incentive
n=948 Participants
Counseling from WTQL; Financial incentive to participate
Total
n=1900 Participants
Total of all reporting groups
Age, Continuous
44.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
45.0 years
STANDARD_DEVIATION 11.2 • n=7 Participants
45.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male
Female
577 Participants
n=5 Participants
569 Participants
n=7 Participants
1146 Participants
n=5 Participants
Sex: Female, Male
Male
375 Participants
n=5 Participants
379 Participants
n=7 Participants
754 Participants
n=5 Participants
Race/Ethnicity, Customized
White
390 Participants
n=5 Participants
393 Participants
n=7 Participants
783 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
487 Participants
n=5 Participants
485 Participants
n=7 Participants
972 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
18 Participants
n=5 Participants
16 Participants
n=7 Participants
34 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
36 Participants
n=5 Participants
38 Participants
n=7 Participants
74 Participants
n=5 Participants
Race/Ethnicity, Customized
Refused/Do not know/Not collected
18 Participants
n=5 Participants
15 Participants
n=7 Participants
33 Participants
n=5 Participants
Region of Enrollment
United States
952 Count of Participants
n=5 Participants
948 Count of Participants
n=7 Participants
1900 Count of Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Control
n=952 Participants
Counseling from WTQL
Incentive
n=948 Participants
Counseling from WTQL; Financial incentive to participate
Abstinence From Smoking
131 Participants
205 Participants

SECONDARY outcome

Timeframe: Measured 6 months after enrollment at follow-up assessment

This analysis will compare number of calls completed

Outcome measures

Outcome measures
Measure
Control
n=952 Participants
Counseling from WTQL
Incentive
n=948 Participants
Counseling from WTQL; Financial incentive to participate
Engagement in Treatment
Zero Calls Taken
6 Participants
3 Participants
Engagement in Treatment
1 Call Taken
245 Participants
76 Participants
Engagement in Treatment
2 Calls Taken
179 Participants
113 Participants
Engagement in Treatment
3 Calls Taken
154 Participants
122 Participants
Engagement in Treatment
4 Calls Taken
165 Participants
199 Participants
Engagement in Treatment
5 Calls Taken
203 Participants
435 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=952 Participants
Counseling from WTQL
Incentive
n=948 Participants
Counseling from WTQL; Financial incentive to participate
Cost-effectiveness
5193 U.S. Dollars
4108 U.S. Dollars

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Incentive

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stevens S. Smith, Ph.D.

University of Wisconsin School of Medicine and Public Health

Phone: 6082627563

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place