Project Summary
PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.
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?
People with serious mental illness (such as schizophrenia, bipolar disorder, or major depression) tend to die about 25 years earlier than those without serious mental illness. Many of these deaths are from smoking-related illnesses. Research shows that many people who smoke and have serious mental illness want to quit smoking. Proven methods are available to help this population stop smoking. But doctors rarely use these methods as part of routine care.
This study compares three different ways to help doctors work with patients with serious mental illness to help them stop smoking.
Who can this research help?
This research can help healthcare leaders and health insurers choose ways to train doctors how to help people with serious mental illness stop smoking. In turn, doctors can use what they learn to help patients stop smoking.
What is the research team doing?
The research team is working with primary care clinics that treat 1,300 adult patients with serious mental illness who smoke. The team is assigning clinics to one of two groups by chance. The first group provides its patients with regular medical and mental health care. In the second group, doctors are getting training about how to use evidence-based treatments to help patients stop smoking. Half of the patients in the second group also get help from community health workers. The community health workers help patients communicate with their doctors and follow treatment plans.
The research team is following up with patients for three years. The team wants to find out whether training doctors about treatments to stop smoking and using community health workers helps people with serious mental illness stop smoking. The research team is also asking patients about their quality of life to see if it improves when patients get help to quit smoking.
The research team is working with many groups to design and carry out this study and share the results. These groups include doctors, nurses, patients with serious mental illness and their families, health insurers, mental health organizations, government agencies, and health clinics.
Research methods at a glance
| Design Element | Description |
|---|---|
| Study Design | Randomized controlled trial |
| Population | Adults ages 18 and older who smoke, have a serious mental illness (e.g., schizophrenia, bipolar disorder, major depressive disorder), and are receiving mental health treatment |
| Interventions/ Comparators |
|
| Outcomes |
Primary: tobacco abstinence Secondary: quality of life |
 |
3-year follow-up for primary outcome |
Project Details