Evaluation of Community Health Worker Support to Help People With Serious Mental Illness to Quit Smoking

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07789132
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular (CV) Risk
  • Community Health Workers
  • Nicotine Dependance
  • Serious Mental Illness
  • Smoking (Tobacco) Addiction
  • Tobacco Cessation
  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Integrated CHW Support intervention — BEHAVIORAL
    Participants 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) — BEHAVIORAL
    Participants 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.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2030

Study Design

Enrollment
937 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Integrated CHW support intervention
    The randomization will be at the level of intensive care managers (ICM). Randomization will be stratified by care team. ICMs in this arm will be assigned to receive CHW and Tobacco Treatment Specialist certificate training (ICM-T) . Participants receive support from their ICM who has received CHW and TTS (ICM-T) training
  • Other: Enhanced usual care (EUC)
    The randomization will be at the level of intensive care managers (ICM). Randomization will be stratified by care team. ICMs in this arm (active-controlled) will not receive CHW and TTS training, participants will receive enhanced usual care (EUC) e.g. continue to receive ICM care.

Primary Outcome Measure

Biochemically Verified 7-Day Point Prevalence Abstinence From Combusted Tobacco [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Addiction Medicine - Massachusetts General HospitalBostonMassachusetts02114
Gladys Pachas, MD, MPH
[email protected]
617-643-1991
Anne Eden Evins, MD, MPH (PRINCIPAL_INVESTIGATOR)
Corinne Cather, PhD (SUB_INVESTIGATOR)
Gladys N Pachas, MD, MPH (SUB_INVESTIGATOR)
Harrison Reeder, PhD (SUB_INVESTIGATOR)
Cheryl Shee, PhD (SUB_INVESTIGATOR)

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By research site
Center for Addiction Medicine - Massachusetts General Hospital· Boston, MA

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