Financial Incentives for Smoking Cessation Treatment Engagement

Randomized Test of Financial Incentives for Smoking Cessation Treatment Engagement Among A Healthcare System's Universal Primary Care Population

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.

Study Overview

• Status: Completed
• Conditions: Quitting Smoking
• Intervention / Treatment: Other: No Financial Incentive; Other: Financial Incentive (100 dollars); Other: Financial Incentive (50 dollars)

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No Financial Incentive; N=180 participants randomized to not be offered monetary incentive to participate in an intervention to quit smoking.	Other: No Financial Incentive; No monetary incentive to participate in quit planning and quit counseling with a tobacco cessation specialist.
Experimental: Financial Incentive (100 dollars); N=180 randomized participants will be offered a 100 dollar incentive to participate in an intervention to quit smoking.	Other: Financial Incentive (100 dollars); Financial incentive (100 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.
Experimental: Financial Incentive (50 dollars); N=180 randomized participants will be offered a 50 dollar incentive to participant in an intervention to quit smoking.	Other: Financial Incentive (50 dollars); Financial incentive (50 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling	The relation between treatment engagement financial incentive amounts offered and likelihood of patient engagement in smoking cessation treatment will be assessed by the number of participants who set a TQD and complete two phone counseling calls.	up to 60 days from enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Month Smoking Abstinence Rates	Exploratory analysis on the effects of the different incentive engagement amounts on biochemically confirmed abstinence 6-month post quit date.	Biochemical confirmation of abstinence occurred within 1-9 days following completion of 6-month post quit date follow-up.

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michael C Fiore, MD, MPH, MBA, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: smoking cessation; financial incentives
• Other Study ID Numbers: 2020-0717; A534253 (Other Identifier: UW Madison); SMPH/MEDICINE/GEN INT MD (Other Identifier: UW Madison); Protocol Version 1/6/2021 (Other Identifier: UW Madison); 3R35CA197573-06S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data collected during the trial, after deidentification. Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose, for independent verification of study outcomes, or to conduct subsequent clinical research.
• IPD Sharing Time Frame: Beginning 12 months after publication of primary outcomes, and ending 5 years after that date.
• IPD Sharing Access Criteria: Proposals should be directed to [PI Michael Fiore, MD at UW-CTRI (mcf@ctri.wisc.edu)]. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No