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Tobacco Quit Line Re-enrollments for the Underserved

This study has been completed.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
Alere Wellbeing
ClinicalTrials.gov Identifier:
NCT01260597
First received: December 14, 2010
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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.

Condition Intervention
Smoking
 Behavioral: IVR intervention
Behavioral: IVR control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Re-engagement in Evidence-based Quit Line Treatment for Low Income Smokers

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Alere Wellbeing:

Primary Outcome Measures:
  • Quit line re-enrollment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Tobacco Abstinence [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 2985
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260597

Locations
United States, Washington
Free & Clear, Inc
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Alere Wellbeing
Indiana University School of Medicine
Investigators
Principal Investigator: Beatriz Carlini, PhD, MPH Free & Clear, Inc.
  More Information

No publications provided by Alere Wellbeing

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alere Wellbeing
ClinicalTrials.gov Identifier: NCT01260597     History of Changes
Other Study ID Numbers: 0002, 1R21CA14156801
Study First Received: December 14, 2010
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alere Wellbeing:
smoking
quit line re-enrollment and IVR systems

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 22, 2013