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

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

Integrated CHW Support intervention

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.

BEHAVIORAL

Enhanced usual care (EUC)

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.

Sponsors & Collaborators

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Anne Eden Evins, MD, MPH · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2029-10-31

Completion

2030-10-31

Countries

• United States

Study Locations