Helping Poor Smokers Quit

Study Details

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.

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

1944 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 :

Jun 5, 2017

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

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

Primary Outcome Measures

Abstinence 6-months [6 months post-baseline]
Report 7-day point prevalence abstinence measured at 6-months post --baseline

Secondary Outcome Measures

Abstinence 3-months [3 months post-baseline]
Report 7-day point prevalence abstinence measured at 3-months post-baseline
24hr Quit Attempt [6 months post-baseline]
Report quitting smoking for at least 24 hours during intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis	Saint Louis	Missouri	United States	63130

Sponsors and Collaborators

Washington University School of Medicine
National Institutes of Health (NIH)
National Cancer Institute (NCI)

Investigators

Principal Investigator: Matthew Kreuter, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

Responsible Party:

Matthew Kreuter, Associate Dean for Public Health; Director, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT03194958

Other Study ID Numbers:

R01CA201429
R01CA201429

First Posted:

Jun 21, 2017

Last Update Posted:

May 27, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tobacco Use Disorder

Study Results

No Results Posted as of May 27, 2021