SmokingNCT01260597
Tobacco Quit Line Re-enrollments for the Underserved
A study testing IVR intervention in people with Smoking, run by Consumer Wellness Solutions at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- IVR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,985 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Primary use of other forms of tobacco such as smokeless tobacco, not understanding English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- IVR intervention, IVR control
- Keywords
- smoking, quit line re-enrollment and IVR systems
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR interventionBehavioural
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 controlBehavioural
If individuals report any smoking in the last 30 days the IVR will thank them for their time and the call will end
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: IVR control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months
Secondary outcomes (1)
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.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consumer Wellness Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Beatriz Carlini, PhD, MPH, Principal investigator, Free & Clear, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260597
- Sponsor's protocol ID
- 0002
- Other IDs
- 1R21CA14156801
- Status last verified
- Aug 2015
- First submitted
- 14 Dec 2010
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22768793
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-engagement in Evidence-based Quit Line Treatment for Low Income Smokers
- ClinicalTrials.gov ID
- NCT01260597
- Acronym / sponsor ID
- 0002
- Conditions
- Smoking
- Keywords
- smoking, quit line re-enrollment and IVR systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,985 participants (actual)
- Lead sponsor
- Consumer Wellness SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life Style Counseling | Experimental | Behavioral: IVR interventionFor 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. |
| Life Counseling | Active comparator | Behavioral: IVR controlFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Primary use of other forms of tobacco such as smokeless tobacco, not understanding English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR interventionIf 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 | Behavioural | Life Style Counseling |
| IVR controlIf individuals report any smoking in the last 30 days the IVR will thank them for their time and the call will end | Behavioural | Life Counseling |
Primary outcome
Quit line re-enrollment
Time frame: At 6 months
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.
1 secondary outcome
Tobacco Abstinence
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
- Derived from this study: PubMed 22768793Carlini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Carlini, PhD, MPH principal investigator
Free & Clear, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR intervention in people with Smoking, run by Consumer Wellness Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit line re-enrollment (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.