NCT03760107

Brief Summary

Improved strategies and scalable interventions to engage low-socioeconomic status (SES) smokers in tobacco treatment are needed. The investigators tested an intervention designed to connect low-SES smokers to treatment services, implemented through Minnesota's National Breast and Cervical Cancer Early Detection Program (Sage) in 2017. Participants were female smokers from Sage (N=3,365). Using a factorial design, participants were randomized to six intervention groups consisting of a proactive call (no call vs call) and/or a financial incentive offered for being connected to treatment services (three levels of incentives). All individuals received direct mail and could opt for cessation support through Minnesota's population-based cessation services. The primary outcome was confirmed connection via phone to the free quit-line.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,723

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

June 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 26, 2018

Last Update Submit

November 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Phone-only treatment connection

    Our primary outcome was phone-only treatment connection, which was defined as a confirmed connection between participants and quit-line staff via three-way calls conducted by patient navigators (1=yes, 0=no).

    3 months

Study Arms (6)

Incentive Level High, Call

EXPERIMENTAL
Behavioral: Connect Smokers to Treatment 1

Incentive Level High, No Call

EXPERIMENTAL
Behavioral: Connect Smokers to Treatment 2

Incentive Level Medium, Call

EXPERIMENTAL
Behavioral: Connect Smokers to Treatment 3

Incentive Level Medium, No Call

EXPERIMENTAL
Behavioral: Connect Smokers to Treatment 4

No Incentive, Call

EXPERIMENTAL
Behavioral: Connect Smokers to Treatment 5

No Incentive, No Call

EXPERIMENTAL
Behavioral: Connect Smokers to Treatment 6

Interventions

Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.

Incentive Level High, Call

Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.

Incentive Level High, No Call

Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.

Incentive Level Medium, Call

Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.

Incentive Level Medium, No Call

Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.

No Incentive, Call

Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.

No Incentive, No Call

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Uninsured women
  • Household incomes at or below 250% of the U.S. federal poverty levels
  • Individuals who reported smoking (from 2014 to 2017)

You may not qualify if:

  • Non-smokers
  • Men
  • Not a National Breast and Cervical Cancer Early Detection Program patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minnesota Department of Health

Saint Paul, Minnesota, 55164, United States

Location

Related Publications (1)

  • Parks MJ, Hughes KD, Keller PA, Lachter RB, Kingsbury JH, Nelson CL, Slater JS. Financial incentives and proactive calling for reducing barriers to tobacco treatment among socioeconomically disadvantaged women: A factorial randomized trial. Prev Med. 2019 Dec;129:105867. doi: 10.1016/j.ypmed.2019.105867. Epub 2019 Oct 18.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 30, 2018

Study Start

June 1, 2017

Primary Completion

October 31, 2017

Study Completion

December 20, 2017

Last Updated

November 30, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations