Helping Poor Smokers Quit

NCT03194958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1944

Last updated 2023-12-26

Study results available
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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.

Conditions

  • 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

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Cancer Institute (NCI)

    collaborator NIH
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Matthew Kreuter, PhD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194958 on ClinicalTrials.gov