Incentives for Smoking Cessation in Persistent Poverty Counties

Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline in Counties Experiencing Persistent Poverty

The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation counseling and self-reported abstinence at follow-up among Oklahoma Tobacco Helpline (OTH) callers living in persistent poverty counties (PPCs). The study will enroll at least 160 adults who reside in any of the 16 persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the OTH.

Study Overview

• Status: Completed
• Conditions: Tobacco Cessation; Tobacco Use; Tobacco Smoking; Smoking Cessation Financial Incentives; Socioeconomic Status; Contingency Management
• Intervention / Treatment: Other: Standard Care; Behavioral: Standard Care + Financial Incentives

Detailed Description

The proposed randomized controlled trial will enroll adults who are seeking smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. Participants will be randomly assigned to OTH or OTH plus escalating incentives (OTH+I) for completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based intervention will focus on counseling call completion, follow-up assessment completion, smoking cessation, incentive costs, and perceptions of the intervention. Potential effectiveness will be evaluated based on comparisons of counseling call completions and rates of self-reported smoking abstinence at 12 weeks post-enrollment (4 weeks after incentives have ended) in OTH+I relative to OTH alone.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • TSET Health Promotion Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Contact the OTH seeking smoking cessation treatment
2. Reside in any of the 16 PPCs in Oklahoma (Adair, Caddo, Cherokee, Choctaw, Greer, Harmon, Haskell, Hughes, Johnston, McCurtain, Okfuskee, Payne, Pushmataha, Seminole, Sequoyah, Tillman)
3. Report smoking ≥ 5 cigarettes per day
4. Are ≥ 18 years of age
5. Are able to provide a copy/photo of their ID/driver's license or other documentation of identity and residence
6. Be able to read, speak, and understand English
7. Have no contradictions for NRT

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.	Other: Standard Care; Financial Incentives participants will receive standard care for completing counseling calls.
Experimental: Standard Care + Financial Incentives; Financial Incentives participants will receive standard care for completing counseling calls.	Other: Standard Care; Financial Incentives participants will receive standard care for completing counseling calls.; Behavioral: Standard Care + Financial Incentives; Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure:	The primary outcome measure is self-reported smoking abstinence 7-day point prevalence at 12 weeks post-quit.	12 weeks post-quit-date
Cost-effectiveness	The incremental cost effectiveness ratio (ICER) calculated as the difference in mean costs between the new (CM) and standard treatment (SC) divided by the difference in mean effectiveness between the two, estimates additional resources needed to achieve an increase of one unit of effectiveness. The ICER is then compared with published threshold values for cost-effective interventions. The cost model will include all necessary personnel, hardware, and material costs.	12 weeks post-quit-date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported smoking abstinence	Self-reported 7-day point prevalence abstinence at 8 weeks post-quit-date.	8 weeks post-quit-date

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Darla E. Kendzor, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 13859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available to investigators upon request, after publication of the primary study findings, and with a data-sharing agreement that specifies the investigator(s) will 1) use the data only for research purposes and not to identify any individual participant, 2) store the data on a secure device (e.g., encrypted, password-protected), and 3) destroy or return the data after completion of the analyses.
• IPD Sharing Time Frame: De-identified data will be made available to investigators upon request after publication of the primary study findings.
• IPD Sharing Access Criteria: Data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No