Tobacco Quit Line Re-enrollments for the Underserved

NCT01260597 | Completed

• 2 other identifiers: 00021R21CA14156801
• Study Type: interventional
• Target: 2,985
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Smoking

Keywords

smoking; quit line re-enrollment and IVR systems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tobacco Abstinence

  At 6 months

Study Arms (2)

Life Style Counseling

EXPERIMENTAL

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

Life Counseling

ACTIVE COMPARATOR

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

Interventions

IVR intervention BEHAVIORAL

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

Life Style Counseling

IVR control BEHAVIORAL

If individuals report any smoking in the last 30 days the IVR will thank them for their time and the call will end

Life Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Consumer Wellness Solutions: lead
• Indiana University School of Medicine: collaborator

Study Sites (1)

Free & Clear, Inc

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 22768793 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Beatriz Carlini, PhD, MPH

  Free & Clear, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

US (1)