- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02737566
Small Financial Incentives to Promote Smoking Cessation (Prevail_II)
Small Financial Incentives to Promote Smoking Cessation in Safety Net Hospital Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals (N = 320) will be recruited during their initial visit to the Tobacco Cessation Clinic. Eligible participants (N = 320) will be randomized to: 1) Standard Care, which is counseling and pharmacological treatment (SC; n = 160), or 2) SC + adjunctive financial incentives through 12 weeks post-quit (CM; n = 160). All participants will be followed weekly from 1 week pre-quit through 4 weeks post-quit, and will return for visits at 8, 12, and 26 weeks post-quit. Biochemically verified 7-day point prevalence abstinence will be assessed at all visits, though abstinence at 26 weeks post-quit (longer-term abstinence) will serve as the primary outcome variable. Those randomized to the CM intervention will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The value of the gift cards will escalate weekly with continuous abstinence from the quit date through 4 weeks post-quit. Additional gift cards for abstinence may be earned at 8 and 12 weeks post-quit. We also hope to gain a better understanding of CM treatment mechanisms and to identify other factors that directly influence cessation via traditional questionnaire and smartphone-based ecological momentary assessment approaches. Smartphone technology allows for "real-time" data collection to more accurately capture important cessation-related variables, and will be used to deliver gain-framed messages to support and strengthen the CM intervention. Participants will complete traditional questionnaire measures on a laptop computer weekly from 1 week pre-quit through 4 weeks post-quit, and at 8, 12, and 26 weeks post-quit. Assessments will be completed by participants either before or after their counseling appointments, for which they will receive reimbursement in the form of gift cards. Participants will also receive a smartphone at the 1 week pre-quit visit and they will be asked to carry it with them at all times through 4 weeks post-quit in order to complete EMAs (5 weeks total). Participants will be prompted to complete EMA assessments 5 times per day (4 random assessments + 1 daily diary) for five consecutive weeks. Participants will be compensated upon the return of the smartphone, based on the percentage of random/daily diary assessments that they completed.
Description of Standard Care. According to the Clinical Practice Guideline, currently recommended components of an intensive tobacco treatment intervention include 1) initial assessment of willingness to participate, 2) the use of multiple types of clinicians (e.g., medical, non-medical), 3) at least 4 treatment sessions, in an individual- or group-counseling format, that are greater than 10 minutes in duration, 4) counseling that includes problem-solving, skills training, and social support components, and 5) and the opportunity to use effective medications to aid in tobacco cessation (e.g., nicotine patch, varenicline). The clinic currently offers all components of standard care. Specifically, individuals who would like to quit smoking are referred (typically via electronic medical record). Patients are scheduled for their initial appointment with a Tobacco Treatment Specialist for an individual counseling session and to discuss pharmacological treatment options. Nicotine replacement therapy is provided during the session, or other medications are prescribed via communication with the patient's physician or by a provider on-site. Those enrolled in the current study will be encouraged to attend at least 5 weekly group sessions to facilitate follow-up and the delivery of study incentives.
Visit 1, Part 1 (Recruitment/Screening). Individuals attending the initial clinic intake session will be provided with a 1-page informational handout with information about the study. After the session, study staff will check in with potential participants regarding their interest. Study staff will review the consent form with interested participants, and they will be screened for eligibility on-site in a private room in the clinic. Participant eligibility for the current study will not influence eligibility for standard treatment through the clinic. The Rapid Estimate of Adult Literacy in Medicine (REALM; see Appendix A) will be administered to ensure that all participants are able to read at ≥ sixth grade level (i.e., required to complete EMA and self-report questionnaires). Expired carbon monoxide (CO) will be measured with a Vitalograph BreathCO carbon monoxide monitor. Participants will be questioned about their 1) insurance status 2) age, 3) current level of smoking, 4) willingness to quit smoking, and 5) willingness/ability to attend 6 weekly sessions (including the first visit). Eligible participants may complete the assessment portion of visit 1.
Visit 1, Part 2 (Pre-Quit Assessment). Participants will complete self-report questionnaires on a laptop computer; and expired CO, weight, and height will be measured in a private room to ensure confidentiality. Participants will be provided with an Android smartphone and instructed regarding the use of the phone (participants may make personal calls) as well as the EMA procedures. Participants will receive 4 random prompts and 1 daily diary prompt (in the morning) during the normal waking hours each day for four consecutive weeks. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first), on the evening prior to their next scheduled counseling session (one week later). Participants will be randomized to Standard Care (SC) or CM using a random numbers table and advised of their group assignment at the conclusion of visit 1. The appropriate schedule of payments (SC or CM) will be discussed with all participants (see Table 1). Visit 1 takes approximately 1 hour to complete, and participants will be scheduled to return for visit 2.
Visit 2 (Quit Day). Participants will complete self-report questionnaires on a laptop computer; and expired CO and weight will be measured in a private room to ensure confidentiality. Visit 2 takes approximately 40 minutes to complete. Participants randomized to the CM treatment will receive an additional payment if they self-report abstinence from smoking since 10 p.m. the prior evening, and their expired is CO level is < 10 ppm (please note that the less stringent cut-off of 10 ppm will be used to verify abstinence at the first visit only, due to the recency of quitting). Participants who do not attend will be contacted by phone to obtain their self-reported smoking status only.
Visit 3 (1 Week Post-Quit). Participants will complete self-report questionnaires on a laptop computer; and expired carbon monoxide (CO) and weight will be measured in a private room to ensure confidentiality. Visit 3 takes approximately 30 minutes to complete. Participants randomized to the CM treatment will receive an additional payment if they self-report continuous abstinence from smoking since the quit day and have an expired CO level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.
Visit 4 (2 Weeks Post-Quit). Expired carbon monoxide (CO) and weight will be measured in a private room to ensure confidentiality. The visit 4 assessment takes approximately 5 minutes to complete. Participants randomized to the CM treatment will receive payment if they self-report continuous abstinence from smoking since the quit date and have an expired CO level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.
Visit 5 (3 Weeks Post-Quit). Expired carbon monoxide (CO) and weight will be measured in a private room to ensure confidentiality. The visit 5 assessment will take approximately 5 minutes to complete. Participants randomized to the CM treatment will receive payment if they self-report continuous abstinence from smoking since the quit date and have an expired CO level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.
Visit 6 (4 Weeks Post-Quit). Participants will complete self-report questionnaires on a laptop computer; and expired CO and weight will be measured in a private room to ensure confidentiality. The visit 6 assessment will take approximately 50 minutes to complete. Upon return of the smartphones, participants will be compensated based on the percentage of completed random assessments. Participants who do not attend will be contacted by phone and/or mail to request that the phone be returned by mail (postage paid envelopes will be sent) or in-person at the next visit. When participants return the phone they will be compensated according to the compensation schedule described above. Participants randomized to the CM treatment will receive an additional payment if they self-report continuous abstinence from smoking since the quit date and have an expired CO level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.
Visit 7 (8 Weeks Post-Quit). Participants will complete self-report questionnaires on a laptop computer; and expired CO and weight will be measured in a private room to ensure confidentiality. Participants will receive a payment for completion of the in-person assessments, which will take approximately 30 minutes to complete. Participants randomized to the CM treatment will receive an additional payment if they self-report abstinence from smoking over the past 7 days and have an expired CO level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.
Visit 8 (12 Weeks Post-Quit). Participants will complete self-report questionnaires on a laptop computer; and expired CO and weight will be measured in a private room to ensure confidentiality. Participants will receive a payment for completion of the in-person assessments, which will take approximately 30 minutes to complete. Participants randomized to the CM treatment will receive an additional payment if they self-report abstinence from smoking over the past 7 days and have an expired CO level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.
Visit 9 (26 Weeks Post-Quit Follow-Up). Participants will complete self-report questionnaires on a laptop computer; and expired CO and weight will be measured in a private room to ensure confidentiality. Participants will receive a payment for completion of the in-person assessments, which will take approximately 40 minutes to complete. Saliva cotinine will also be measured via NicAlert test strips to provide additional evidence of abstinence. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- TSET Health Promotion Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- are currently uninsured or receiving Medicaid benefits
- earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level
- are willing to quit smoking 7 days from their first visit
- are ≥ 18 years of age
- have an expired CO level ≥ 8 ppm suggestive of current smoking
- are currently smoking ≥ 5 cigarettes per day
- are willing and able to attend 9 study visits.
Exclusion Criteria:
- are unwilling to quit smoking 7 days from their first visit
- have already quit smoking
- earn a score <4 on the REALM indicating < 7th grade literacy level
- produce an expired CO level < 8 ppm
- are currently smoking < 5 cigarettes per day
- are unwilling or unable to attend study visits
- are < 18 years of age
- are not uninsured or receiving Medicaid benefits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard Care + Financial Incentives
Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit.
The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence.
Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level.
Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.
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Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.
|
Active Comparator: Standard Care
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
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Tobacco cessation counseling plus pharmacotherapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically-verified Smoking Cessation
Time Frame: 26 weeks post-quit
|
The primary outcome measure is carbon monoxide (CO)-verified 7-day point prevalence abstinence at 26 weeks post-quit (intent-to-treat; missing=smoking).
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26 weeks post-quit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically-verified Smoking Cessation
Time Frame: 12 weeks post-quit
|
The secondary outcome measure is Carbon Monoxide (CO)-verified 7-day point prevalence abstinence at 12 weeks post-quit (intent-to-treat; missing=smoking).
|
12 weeks post-quit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Darla E. Kendzor, Ph.D., University of Oklahoma
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6260
- R01CA197314 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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