Project Summary
PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project and others.
COVID-19-Related Project EnhancementTo reduce the spread of the COVID-19 virus, many health systems now offer telehealth. Telehealth provides care to patients remotely using phone, video, or other devices that can help manage care. But some services still need to be in person.
With this enhancement, the research team will identify ways to improve access to two preventive health services during the pandemic: programs to help patients quit smoking and lung cancer screening. People who smoke or need screening for lung cancer may have a higher risk of complications for COVID-19. Also, lung cancer screening can only be in person. The team will collect data from patients and providers to inform decisions about these services.
Enhancement Award Amount: $491,910
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This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Quitting smoking can help people live longer, healthier lives. Medical guidelines recommend that people in certain age groups who have a history of smoking should get screened for lung cancer. Screening appointments are an opportunity for health systems to offer programs to support patients in quitting smoking.
Many programs help people quit smoking. But these programs may not work equally well for all groups of people. In this study, the research team is comparing combinations of programs to see which approaches help people who are black or Hispanic, people with low levels of education or low incomes, or people who live in rural areas quit smoking. The team is focusing on how well these combinations work when offered at the time of lung cancer screening.
Who can this research help?
The results of this study can help lung cancer screening programs choose the best ways to help patients quit smoking.
What is the research team doing?
The research team is recruiting 3,200 current smokers who are referred for lung cancer screening at four large health systems. All patients are black or Hispanic, have low incomes, or live in a rural area.
The research team is assigning patients by chance to one of four approaches to encourage them to stop smoking:
- Ask-Advise-Refer. In this approach, a clinician asks the patient about his or her desire to quit, advises them to quit, and refers the patient to resources such as a quitline.
- Ask-Advise-Refer plus free prescription medicine to help patients quit and free nicotine patches, gum, and lozenges.
- The first two ways plus paying people for successfully quitting smoking
- All of the above ways plus an app that helps people to imagine their future and what life would be like if they didn’t smoke.
The research team is looking at how well each approach helps patients to stop smoking for six months after the date they choose to quit. The team is also comparing how the approaches work for patients of different races, incomes, and communities. The team is also looking at whether patients have successfully avoided smoking 12 and 18 months after their quit date. For the first six months, the team is collecting information from patients three times. The team is asking patients about how motivated they are to quit, how confident they feel about their ability to quit, what might keep them from quitting, and their quality of life.
Patients who have quit smoking, doctors, and community members are helping the research team plan and conduct the study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Current smokers referred for low-dose computed tomography screening for lung cancer who are black or Hispanic, and/or have low socioeconomic status, or live in a rural area |
| Interventions/ Comparators |
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| Outcomes |
Primary: tobacco cessation for 6 months Secondary: relapse rates at 12 and 18 months, self-reported motivation to quit, self-efficacy related to cessation efforts, perceived barriers to cessation, health-related quality of life |
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6-month follow-up for primary outcome |
Project Details
Drug Interventions
Other Clinical Interventions
Shared Decision Making
Incentives for Behavior Change
Technology Interventions
Older Adults
Racial/Ethnic Minorities
Rural
Women
Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes