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
  • Training to help doctors stay up to date with what research suggests are the most effective ways to help people with serious mental illness stop smoking
  • Training to help doctors stay up to date with what research suggests are the most effective ways to help people with serious mental illness stop smoking, plus support for healthcare providers and patients from community health workers
  • Usual care, consisting of regular medical and mental health care

Primary: tobacco abstinence

Secondary: quality of life

Timeframe 3-year follow-up for primary outcome

Project Information

Eden Evins, MD, MPH
Massachusetts General Hospital
Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illness

Key Dates

January 2016
August 2023

Study Registration Information


Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: January 24, 2024