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Patient-Centered Outcomes Research Institute

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  • Research & Results
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  • Helping People with Serious Mental Il...

Helping People with Serious Mental Illness Stop Smoking

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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
  • 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
Outcomes

Primary: tobacco abstinence

Secondary: quality of life

Timeframe 3-year follow-up for primary outcome

Project Details

Principal Investigator
Eden Evins, MD, MPH
Project Status
In progress; Data collected
Project Title
Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illness
Board Approval Date
January 2016
Project End Date
August 2022
Organization
Massachusetts General Hospital
Year Awarded
2016
State
Massachusetts
Project Type
Research Project
Health Conditions  
Cardiovascular Diseases
Hypertension
Mental/Behavioral Health
Bipolar Disorder
Depression
Tobacco Cessation
Serious Mental Illness
Schizophrenia and Psychotic Disorders
Multiple/Comorbid Chronic Conditions
Nutritional and Metabolic Disorders
Diabetes
Intervention Strategies
Behavioral Interventions
Other Clinical Interventions
Care Coordination
Other Health Services Interventions
Training and Education Interventions
Populations
Racial/Ethnic Minorities
Women
Funding Announcement
Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes
Project Budget
$10,480,576
Study Registration Information
HSRP20162206
NCT02845440
Page Last Updated: 
January 21, 2021

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Research & Results

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  • Putting Evidence to Work
  • Peer Review
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  • About Our Research

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Meetings & Events

February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021
February 11
Advisory Panel on Patient Engagement Winter 2021 Meeting

PCORI

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Research Institute

1828 L Street, NW, Suite 900
Washington, DC 20036
Phone: (202) 827-7700 | Fax: (202) 355-9558
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