Helping Poor Smokers Quit
Primary Purpose
Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specialized Quitline
Basic Needs Navigator
Sponsored by
About this trial
This is an interventional health services research trial for Smoking Cessation
Eligibility 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
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Standard Quitline
Specialized Quitline
Standard Quitline with Basic Needs Navigator
Specialized Quitline with Basic Needs Navigator
Arm Description
Participants will receive standard Missouri quitline services
Participants will receive an enhanced version of the standard quitline services
Participants receive standard quitline services with navigator
Participants receive enhanced quitline services with navigator
Outcomes
Primary Outcome Measures
Abstinence 6-months
Report 7-day point prevalence abstinence measured at 6-months post --baseline
Secondary Outcome Measures
Abstinence 3-months
Report 7-day point prevalence abstinence measured at 3-months post-baseline
24hr Quit Attempt
Report quitting smoking for at least 24 hours during intervention
Full Information
NCT ID
NCT03194958
First Posted
June 19, 2017
Last Updated
May 25, 2021
Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03194958
Brief Title
Helping Poor Smokers Quit
Official Title
Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1944 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Quitline
Arm Type
No Intervention
Arm Description
Participants will receive standard Missouri quitline services
Arm Title
Specialized Quitline
Arm Type
Experimental
Arm Description
Participants will receive an enhanced version of the standard quitline services
Arm Title
Standard Quitline with Basic Needs Navigator
Arm Type
Experimental
Arm Description
Participants receive standard quitline services with navigator
Arm Title
Specialized Quitline with Basic Needs Navigator
Arm Type
Experimental
Arm Description
Participants receive enhanced quitline services with navigator
Intervention Type
Behavioral
Intervention Name(s)
Specialized Quitline
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Basic Needs Navigator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Abstinence 6-months
Description
Report 7-day point prevalence abstinence measured at 6-months post --baseline
Time Frame
6 months post-baseline
Secondary Outcome Measure Information:
Title
Abstinence 3-months
Description
Report 7-day point prevalence abstinence measured at 3-months post-baseline
Time Frame
3 months post-baseline
Title
24hr Quit Attempt
Description
Report quitting smoking for at least 24 hours during intervention
Time Frame
6 months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Kreuter, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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McQueen A, Kreuter MW, Boyum S, Thompson VS, Caburnay CA, Waters EA, Kaphingst KA, Rath S, Fu Q. Reactions to FDA-Proposed Graphic Warning Labels Affixed to U.S. Smokers' Cigarette Packs. Nicotine Tob Res. 2015 Jul;17(7):784-95. doi: 10.1093/ntr/ntu339. Epub 2015 Jan 14.
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http://www.siteman.wustl.edu
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
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Helping Poor Smokers Quit
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