Financial Incentives for Smoking Cessation Treatment Engagement

NCT ID: NCT04601870

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2022-06-17

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.

Conditions

Quitting Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

No Financial Incentive

N=180 participants randomized to not be offered monetary incentive to participate in an intervention to quit smoking.

Group Type: EXPERIMENTAL

No Financial Incentive

Intervention Type: OTHER

No monetary incentive to participate in quit planning and quit counseling with a tobacco cessation specialist.

Financial Incentive (100 dollars)

N=180 randomized participants will be offered a 100 dollar incentive to participate in an intervention to quit smoking.

Group Type: EXPERIMENTAL

Financial Incentive (100 dollars)

Intervention Type: OTHER

Financial incentive (100 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.

Financial Incentive (50 dollars)

N=180 randomized participants will be offered a 50 dollar incentive to participant in an intervention to quit smoking.

Group Type: EXPERIMENTAL

Financial Incentive (50 dollars)

Intervention Type: OTHER

Financial incentive (50 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.

Interventions

No Financial Incentive

No monetary incentive to participate in quit planning and quit counseling with a tobacco cessation specialist.

Intervention Type: OTHER

Financial Incentive (100 dollars)

Financial incentive (100 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.

Intervention Type: OTHER

Financial Incentive (50 dollars)

Financial incentive (50 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael C Fiore, MD, MPH, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A534253

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/GEN INT MD

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1/6/2021

Identifier Type: OTHER

Identifier Source: secondary_id

3R35CA197573-06S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0717

Identifier Type: -

Identifier Source: org_study_id