Clinical trial NCT04601870: Financial Incentives for Smoking Cessation Treatment Engagement
Official title: Randomized Test of Financial Incentives for Smoking Cessation Treatment Engagement Among A Healthcare System's Universal Primary Care Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quitting Smoking
Keywords: smoking cessation
financial incentives
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants Who Set A Target Quit Date (TQD) and Complete Phone Counseling
timeFrame: up to 60 days from enrollment
Secondary outcomes:
Other outcomes:
measure: 6 Month Smoking Abstinence Rates
timeFrame: Biochemical confirmation of abstinence occurred within 1-9 days following completion of 6-month post quit date follow-up.
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael C Fiore, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References: