Tobacco Quit Line Re-enrollments for the Underserved

Re-engagement in Evidence-based Quit Line Treatment for Low Income Smokers

The purpose of this proposed study is to develop, refine and test the use of Interactive Voice Response (IVR) technology as a means of increasing re-engagement of low income smokers in telephone support for tobacco cessation (quit lines). If this strategy proves to be acceptable and feasible, it may offer a technological solution to increase access to and utilization of a widely available evidence-based form of behavioral treatment for low income smokers.

The primary aims of this research are to:

1. Develop an IVR system that delivers tailored audio messages to increase low income smokers' re-engagement in treatment offered by two state quit lines (Washington and Indiana). The investigators will develop: a) a menu of audio messages that can be delivered by an IVR system; b) an IVR algorithm (i.e., a set of decision rules) to make proactive automated calls to deliver brief, tailored messages for re-engaging low income smokers who previously used the quit line.
2. Evaluate the feasibility and efficacy of an IVR system as a tool to re-engage low income smokers into quit line treatment measured by number of IVR calls answered, number of smokers who re-engage in treatment and satisfaction with IVR calls. Hypothesis 2.1 - It is hypothesized that the rates of re-engagement into treatment among those receiving the IVR intervention will be higher than smokers not proactively invited to re-engage in quit line services.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: IVR intervention; Behavioral: IVR control

Detailed Description

We propose a randomized controlled trial to compare re-engagement into quit line treatment between low income smokers receiving IVR intervention to re-engage into treatment through quit line services and those receiving usual care (no intervention to re-engage). Subjects will be recruited from two state quit lines (Washington (WA) and Indiana (IN)). WA and IN were selected because they both contract with Free & Clear for quit line services and have supported research collaborations in the past. Both states have agreed to participate in this study. Three thousand subjects will be randomized to the intervention or usual care prior to entry into the IVR calling database. This sampling frame was defined based in our past research experience in using similar method to re-engage low income smokers from ethnic populations and assumed a high proportion of invalid phone numbers and difficulties on successfully reaching individuals even after several call attempts. In our previous re-engagement study, 29% of the phone numbers provided by quit line users were invalid 12 months later and 38% of the subjects were never reached after five attempted calls. Therefore, in this study we are anticipating successfully reaching 30% of the sample.

This is a feasibility study and the main outcome is re-engagement into treatment, measured by re-enrollment into quit line support after receiving the IVR intervention. Process measures are IVR calls answered and satisfaction with IVR calls. Thirty-day point prevalence abstinence at 6 months after intervention will be also measured, as a way to preliminarily evaluate the efficacy of this intervention.

The target population of this study is low income smokers, defined as being a Medicaid recipient or uninsured by the time of their first enrollment into quit line treatment. This working definition for eligibility criterion was chosen because health insurance status is routinely assessed in the provision of quit line services and it is a good proxy indicator of income.

• Study Type: Interventional
• Enrollment (Actual): 2985
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Free & Clear, Inc

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Enrolled in Medicaid or uninsured, 18 years or older, able to read and speak English, provided verbal consent to be contacted by quit line to follow-up, sought quit line services for being primarily a smoker

Exclusion Criteria:

• Primary use of other forms of tobacco such as smokeless tobacco, not understanding English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Life Style Counseling; For individuals who report being quit, a brief congratulatory message will be delivered, independent of each arm of the study they were randomized to. For individuals who report not being quit and are randomized to the intervention condition, tailored messages are delivered via the IVR system. The automated calls would include an assessment of the individual's interest in another quit attempt and deliver brief, tailored messages to perceived barriers for re-engaging into treatment. The system is programmed to transfer the caller to a live quit line counselor if the individual is willing to re-engage in cessation treatment.	Behavioral: IVR intervention; If individuals report having any smoking in the previous 30 days, the IVR will deliver questions to identify barriers to quit line re-enrollment and motivational messages to promote the re-enrollment
Active Comparator: Life Counseling; For individuals who report being quit, a brief congratulatory message will be delivered, independent of each arm of the study they were randomized to. For individuals who report still smoking the IVR will thank them for their time and the call will end.	Behavioral: IVR control; If individuals report any smoking in the last 30 days the IVR will thank them for their time and the call will end

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quit line re-enrollment	Evaluate the feasibility and efficacy of an IVR system as a tool to re-engage low income smokers into quit line treatment measured by number of IVR calls answered, number of smokers who re-engage in treatment and satisfaction with IVR calls.	At 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Abstinence	Thirty-day point prevalence abstinence at 6 months after intervention will be also measured, as a way to preliminarily evaluate the efficacy of this intervention.	At 6 months

Collaborators and Investigators

• Sponsor: Consumer Wellness Solutions
• Collaborators: Indiana University School of Medicine
• Investigators: Principal Investigator: Beatriz Carlini, PhD, MPH, Free & Clear, Inc.

Publications and helpful links

General Publications

• Carlini BH, McDaniel AM, Weaver MT, Kauffman RM, Cerutti B, Stratton RM, Zbikowski SM. Reaching out, inviting back: using Interactive voice response (IVR) technology to recycle relapsed smokers back to Quitline treatment--a randomized controlled trial. BMC Public Health. 2012 Jul 6;12:507. doi: 10.1186/1471-2458-12-507.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: smoking; quit line re-enrollment and IVR systems
• Other Study ID Numbers: 0002; 1R21CA14156801 (Other Grant/Funding Number: NCI)