Tobacco Quit Line Re-enrollments for the Underserved

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260597
• Other study ID #: 0002
• Secondary ID: 1R21CA14156801
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: August 10, 2015
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2015
• Source: Alere Wellbeing
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2985
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Free & Clear, Inc	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Alere Wellbeing	Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No