The purpose of this study is to learn whether providing additional smoking cessation support through specially trained members of behavioral healthcare team helps people quit smoking and improve their health. Participants ages 18-75 who receive mental health services and smoke cigarettes every day may qualify for this study looking at new ways to help people quit smoking.
Age 18-75, inclusive
Have been diagnosed with SMI that has qualified them for Medicaid behavioral health services (i.e., mood, anxiety, traumatic, and psychotic disorders with or without functional impairment) and receive care through the community human services organizations in Massachusetts.
Self-report of past year daily tobacco smoking
Able to understand study procedures and communicate in English or Spanish
Have dementia or intellectual disability (estimated IQ< 70)
Not able to communicate in English or Spanish
Unstable medical condition that compromises ability to safely participate, in the investigator's opinion
Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion
Parallel
Integrated CHW Support intervention
BehavioralParticipants assigned to the Integrated CHW Support intervention will receive smoking cessation support from their Intensive Case Manager (ICM), who has completed Community Health Worker (CHW) core competency training and Tobacco Treatment Specialist (TTS) certification. The intervention is integrated into routine case management and includes individualized smoking cessation counseling, education, motivational support, assistance with setting quit goals, facilitation of evidence-based tobacco treatment medications through participants' healthcare providers, coordination of healthcare services, accompaniment to medical appointments when appropriate, and support addressing social determinants of health that may affect tobacco cessation (e.g., housing, transportation, food insecurity, medication access). Participants will receive approximately four in-person or community-based contacts per month, supplemented by telephone or video contacts as needed, over a 18-month intervention period.
Enhanced usual care (EUC)
BehavioralParticipants assigned to Enhanced Usual Care (EUC) will continue to receive standard behavioral health and case management services provided by their Intensive Case Manager (ICM). ICMs assigned to the EUC arm will not receive Community Health Worker (CHW) core competency training or Tobacco Treatment Specialist (TTS) certification and will not deliver the structured Integrated CHW Support intervention.
Biochemically Verified 7-Day Point Prevalence Abstinence From Combusted Tobacco
Number of participants with self-reported abstinence from combusted tobacco products for at least 7 days at the 18-month assessment, biochemically verified using salivary cotinine or expired carbon monoxide (CO). Abstinence will be verified by salivary cotinine \<30 ng/mL. For participants using nicotine replacement therapy (NRT) or e-cigarettes at the time of assessment, expired CO \<5 parts per million (ppm) will be used to verify abstinence from combusted tobacco.
Change in Estimated Cardiovascular Risk (ACC/AHA ASCVD Risk Estimator)
Change in estimated 10-year risk of atherosclerotic cardiovascular disease (ASCVD) from baseline to 18 months, as calculated using the American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD Risk Estimator based on: age, sex, race, blood pressure, smoking status, lipids (HDL and total cholesterol), diabetes diagnosis, HbA1c, antihypertension therapy. Lower estimated risk indicates improvement in cardiovascular risk.
Change in Depressive Symptoms (PHQ-9)
Change in depressive symptom severity from baseline to 18 months, as measured by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Change in Anxiety Symptoms (GAD-7)
Change in anxiety symptom severity from baseline to 18 months, as measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Change in Psychiatric Symptoms (Colorado Symptom Index)
Change in psychiatric symptom severity from baseline to 18 months, as measured by the Colorado Symptom Index (CSI). Higher scores indicate greater psychiatric symptom burden.
Clinical Global Improvement
Clinical improvement at 18 months, as assessed by the Clinical Global Impression-Improvement (CGI-I) scale. Scores range from 1 ("very much improved") to 7 ("very much worse"), with lower scores indicating greater clinical improvement.
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