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Helping Poor Smokers Quit

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ClinicalTrials.gov Identifier: NCT03194958
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Matthew Kreuter, Washington University School of Medicine

Study Description
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Brief Summary:
Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Tobacco Smoking, Cigarette Smoking, Pipe Smoking (Tobacco) Addiction Smoking Tobacco Use Tobacco Dependence Tobacco Use Cessation Tobacco Smoking Tobacco; Use, Rehabilitation Nicotine Dependence Nicotine Use Disorder Nicotine Dependence, Cigarettes Nicotine Dependence Tobacco Product Behavioral: Specialized Quitline Behavioral: Basic Needs Navigator Not Applicable

Detailed Description:

2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.

Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard Quitline
Participants will receive standard Missouri quitline services
Experimental: Specialized Quitline
Participants will receive an enhanced version of the standard quitline services
 Behavioral: Specialized Quitline
Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.
Experimental: Standard Quitline with Basic Needs Navigator
Participants receive standard quitline services with navigator
 Behavioral: Basic Needs Navigator
Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.
Experimental: Specialized Quitline with Basic Needs Navigator
Participants receive enhanced quitline services with navigator
 Behavioral: Specialized Quitline
Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.

Behavioral: Basic Needs Navigator
Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.


Outcome Measures
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Primary Outcome Measures :
  1. Abstinence 6-months [ Time Frame: 6 months post-baseline ]
    Report 7-day point prevalence abstinence measured at 6-months post --baseline


Secondary Outcome Measures :
  1. Abstinence 3-months [ Time Frame: 3 months post-baseline ]
    Report 7-day point prevalence abstinence measured at 3-months post-baseline

  2. 24hr Quit Attempt [ Time Frame: 6 months post-baseline ]
    Report quitting smoking for at least 24 hours during intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years and older
  • Missouri resident
  • English speaking
  • Not in crisis
  • Smoke cigarettes every day of the week
  • Planning to quit smoking in the next 30 days
  • Comfortable receiving calls from smoking expert and project team
  • Willing to provide phone numbers to be reached

Exclusion Criteria:

  • Pregnant or planning to become pregnant in the next 3 months
  • Currently breastfeeding
  • Insurance through employer
  • Currently enrolled in smoking quitline
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194958


Contacts
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Contact: Christina D Roberts, MPH 314-935-2721 christina.roberts@wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Matthew Kreuter, PhD    314-935-3701    mkreuter@wustl.edu   
Contact: Amy McQueen, PhD    314-935-3715    amcqueen@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Matthew Kreuter, PhD Washington University School of Medicine
More Information
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Additional Information:
World Health Organization. Framework Convention on Tobacco Control (FCTC) Health Warnings Database  This link exits the ClinicalTrials.gov site Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

Publications:
Sutherland C, Sullivan C, Bybee D. Effects of intimate partner violence versus poverty on women's health. Violence Against Women. 2001;7(10):1122-1143.

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Responsible Party: Matthew Kreuter, Associate Dean for Public Health; Director, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03194958     History of Changes
Other Study ID Numbers: R01CA201429 ( U.S. NIH Grant/Contract )
R01CA201429 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders