Completed

DTSA POPULATION-BASED DIRECT-TO-SMOKER OUTREACH OFFERING TOBACCO TREATMENT IN A HEALTH CARE SETTING: A RANDOMIZED CONTROLLED TRIAL

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What is being tested

Direct to Smoker Outreach Program

Other
Who is being recruted

Mental Disorders+1

+ Tobacco Use Disorder

+ Substance-Related Disorders

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2009
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

Tobacco use is the leading preventable cause of death in the United States. Effective treatment for tobacco dependence exists and includes counseling and pharmacotherapy with nicotine replacement, bupropion, or varenicline. The health care system is a key channel for delivering this treatment to smokers. Brief clinical interventions delivered at office visits increase smoking cessation rates, are among the most cost-effective of medical interventions, and are recommended by U.S. Public Health Service. However, physicians and other clinicians often fail to provide them. Clinicians' rates of providing tobacco treatment in ambulatory care can be improved, but even when successful, clinicians can only reach smokers who make an office visit. A health care system might improve its delivery of tobacco treatment by supplementing visit-based efforts with a population-based strategy, using methods proven effective in public health settings. A population of smokers could be identified from electronic health records and offered treatment proactively in a way that maximizes convenience and minimizes barriers such the cost of pharmacotherapy. This study tests the effectiveness of a population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one community health center in Revere, MA, that is part of an integrated health care system. It uses the system's population management tools to identify smokers and proactively offers them evidence-based tobacco treatment that is free and does require making an office visit. A randomized controlled trial will compare the effectiveness of the DTS program to usual primary care. The hypothesis is that adding the DTS program to usual primary care will increase the proportion of smokers who use tobacco dependence treatment and thereby stop smoking.

Official TitleA POPULATION-BASED DIRECT-TO-SMOKER OUTREACH OFFERING TOBACCO TREATMENT IN A HEALTH CARE SETTING: A RANDOMIZED CONTROLLED TRIAL
NCT01321944
Principal SponsorMassachusetts General Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

590 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersTobacco Use DisorderSubstance-Related DisordersChemically-Induced Disorders

Criteria

4 inclusion criteria required to participate
Adults (>= 18 years)

made an office visit to a primary care physician (PCP) at Revere Health Center in the year prior to May 2009

has a telephone

listed as a smoker in the past 5 years in the electronic health record

1 exclusion criteria prevent from participating
severe psychiatric or neurologic diagnosis (e.g., psychosis, dementia) on problem list of electronic health record

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention group participants will be sent 3 letters at monthly intervals signed by the participant's PCP that encourages the smoker to quit, and offers a free telephone consultation by Partners' Tobacco Treatment Coordinator (TTC), free nicotine patches, and referral to additional treatment resources including the state's free telephone quitline.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Revere Health Center

Revere, United StatesOpen Revere Health Center in Google Maps
CompletedOne Study Center