Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
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.
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 |
|
| 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 |
| Timeframe | 6-month follow-up for primary outcome |
COVID-19-Related Study
Understanding How the COVID-19 Pandemic Affected Tobacco Use, Quit Intent, and Use of Healthcare Services among Older Adult Smokers
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
COVID-19 is a viral disease that can be mild or severe. Limited access to health care and lung damage from smoking can increase the risk of severe COVID-19. Older adults with limited access to health care are also more likely to be smokers. In-person services like support groups can help people quit or reduce smoking. But the COVID-19 pandemic made it hard for older adults and others to get these services.
In this study, the research team interviewed older adult patients who use tobacco, their caregivers, and doctors to understand:
- Patients’ tobacco use and plans to quit during the pandemic
- Views about using smartphone apps to help quit smoking
- Experience with in-person preventive care for people who use tobacco, like lung cancer screening
What were the results?
Tobacco use and plans to quit during the pandemic. Some patients said they used tobacco more due to worry or boredom. Others said they used tobacco less to reduce the risk of severe COVID-19. Some patients who quit in the past started smoking again due to worry and stress. Patients said that personal willpower and being motivated are the most important factors to help people quit smoking.
Views on smartphone apps. Some patients said they had trouble using apps because they didn’t understand the technology. They also weren’t comfortable using smartphones other than for texting and social media. Some patients thought that video tutorials, instruction manuals, and live support could help people use the apps. Most patients said that apps would only help them quit if they were already motivated to quit smoking.
In-person care. To prevent the spread of COVID-19, doctors said they often postponed care early in the pandemic for patients who used tobacco. Patients said they continued with care recommended by their doctors when it was available later in the pandemic. Social distancing, masking, and vaccines helped patients and caregivers feel safer getting in-person care.
Who was in the study?
The study included 55 adults who smoked every day, 15 caregivers of adults who smoked, and 18 doctors. Among patients, 44 percent were Black, 38 percent were White, and 18 percent were another race; 18 percent were Hispanic or Latino. The median age was 61, and 51 percent were men.
What did the research team do?
The research team recruited patients ages 50–80 who were Black or Hispanic, lived in rural areas, had less than a high school education, or had lower incomes. All received care at one health system or took part in a community outreach program in Pennsylvania. The team conducted interviews by phone between November 2020 and September 2021.
Patients, doctors, members of advocacy groups, and health system staff helped design the study.
What were the limits of the study?
The study took place in one state. Results may differ in other states.
How can people use the results?
Health systems can use the results when considering ways to help older adult smokers reduce or quit smoking.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
Two factors associated with increased risk for developing severe COVID-19 are limited access to health care and lung damage from smoking. Older adults with limited access to health care are also more likely to be smokers. In-person services can help people quit or reduce smoking, but the COVID-19 pandemic restricted access to these services for older adults and others.
Objective
(1) To understand older adults’ tobacco use and smoking cessation plans during the pandemic; (2) To explore barriers and facilitators to using mobile health (mHealth) apps to support quitting smoking; and (3) To understand experiences with in-person, tobacco-related preventive healthcare services
Study Design
| Design Element | Description |
|---|---|
| Design | Qualitative study with semistructured interviews |
| Population | 55 adults ages 50–80 who smoked tobacco daily and were Black or Hispanic, lived in rural areas, had less than a high school level of formal education, or had low incomes; 15 caregivers of adult smokers; and 18 clinicians who treated patients who were smokers |
| Outcomes |
|
| Data Collection Timeframe | November 2020–September 2021 |
This qualitative study explored tobacco use and smoking cessation plans during the pandemic as well as experiences using mHealth apps and in-person services to support quitting smoking among older adults with limited access to health care.
Researchers recruited patients, caregivers, and clinicians from one health system and a state-sponsored mobile community outreach program in Pennsylvania. Between November 2020 and September 2021, researchers conducted semistructured telephone interviews to understand patient, caregiver, and clinician experiences. Researchers analyzed interview transcripts and identified themes.
The study included 55 adult smokers, 15 caregivers of adult smokers, and 18 clinicians living in Pennsylvania. Among patients, 44% were Black, 38% were White, and 18% were another race; 18% were Hispanic or Latino. The median age was 61, and 51% were male.
Patients, clinicians, members of advocacy organizations, and healthcare administrators helped design the study.
Results
Tobacco use and smoking cessation. Smoking habits during the pandemic varied. Some patients reported increasing their tobacco use due to anxiety or boredom; others reduced their tobacco use to lower the risk of severe COVID-19. Some patients who quit in the past started smoking again due to anxiety and stress. Patients said that personal willpower and motivation are the most important facilitators to quitting smoking.
Barriers and facilitators to using mHealth apps for smoking cessation. Patients reported challenges with using mHealth apps. For example, the technology was unfamiliar, and they were uncomfortable using smartphones for purposes other than texting and social media. Some patients said that resources like video tutorials, instruction manuals, and live support may help people use mHealth apps. Most patients emphasized that mHealth apps could only help if a person was committed to quitting smoking.
Experience with in-person, tobacco-related preventive services. To prevent the spread of COVID-19, clinicians said they often postponed preventive care services early in the pandemic for patients who used tobacco. Patients said that they continued with clinician-recommended care once these services resumed. Strategies like social distancing, masking, and vaccination improved patient and caregiver perceptions of safety for in-person preventive care.
Limitations
Researchers interviewed patients from Pennsylvania. Results may differ in other states.
Conclusions and Relevance
This study described changes in tobacco use behaviors, experiences with mHealth, and engagement in in-person, tobacco-related preventive services among older adults during the COVID-19 pandemic. Findings may help health practitioners combat tobacco use during disruptions to regular healthcare access.
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that this study was meant to gain knowledge about smoking behavior and treatment among underserved patients and caregivers during the COVID-19 pandemic, but the study population would not be considered underserved given their engagement in health care, their education level, and poverty level. The researchers explained that they sought to include health disparities populations based on the National Institutes of Health definition and that the study sample did consist of individuals experiencing health disparities, including individuals from racial and ethnic minority groups, lower socioeconomic status, rural living, or a combination of these factors.
- The reviewers also noted that the study did not adequately assess the systemic barriers to accessing smoking cessation treatment, such as systemic racism and poverty, despite stating that its goal was to identify how to overcome such barriers. The researchers explained that their qualitative interviews and analysis focused on more general barriers to receiving smoking treatment during the pandemic, such as use of mHealth technology, and how these general barriers affected people experiencing health disparities. It was not the researchers’ intention to focus on disparities-related barriers to care.
- The reviewers asked whether the study sample might have been biased given the low participation rate from patients and clinicians, and advised the researchers to discuss the potential implications of this low response rate. The reviewers suggested adding a comparison of demographic characteristics for study participants versus nonresponders. The researchers acknowledged that the response rater might have led to selection bias, but they did not have demographic information on the nonresponders and therefore could not describe those differences. The researchers added a discussion about why their recruitment success was limited given the reliance on remote recruitment.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by August 2023.
