NCT04601870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

October 19, 2020

Results QC Date

December 2, 2022

Last Update Submit

December 29, 2022

Conditions

Keywords

smoking cessationfinancial incentives

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 6 Month Smoking Abstinence Rates

    Biochemical confirmation of abstinence occurred within 1-9 days following completion of 6-month post quit date follow-up.

Study Arms (3)

No Financial Incentive

EXPERIMENTAL

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

Other: No Financial Incentive

Financial Incentive (100 dollars)

EXPERIMENTAL

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 (50 dollars)

EXPERIMENTAL

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

Other: Financial Incentive (50 dollars)

Interventions

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

No Financial Incentive

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

Financial Incentive (100 dollars)

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

Financial Incentive (50 dollars)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On Cigarette User Registry at a participating clinic
  • Able to speak English or Spanish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Mark Zehner
Organization
University of Wisconsin-Madison School of Medicine and Public Health Center for Tobacco Research and Intervention

Study Officials

  • Michael C Fiore, MD, MPH, MBA

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 26, 2020

Study Start

February 19, 2021

Primary Completion

December 23, 2021

Study Completion

June 17, 2022

Last Updated

January 25, 2023

Results First Posted

January 25, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 12 months after publication of primary outcomes, and ending 5 years after that date.
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.

Locations