Direct to Smoker Outreach in a Health Care Setting

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Other: Direct to Smoker Outreach Program

• Registration Number: NCT01321944
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Last Update Submitted: 2011-03-22
• Study First Posted: 2011-03-24
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

• 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

Exclusion Criteria

• severe psychiatric or neurologic diagnosis (e.g., psychosis, dementia) on problem list of electronic health record

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DTS intervention	Direct to Smoker Outreach Program	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.

Primary Outcome Measures

Name	Time	Method
proportion of participants who reported using any tobacco dependence treatment during the 3-month study period	3 months	Tobacco dependence treatment is defined as (1) any smoking cessation counseling contact (with the Tobacco Treatment Coordinator, the Massachusetts Smokers Quitline, or in-person counseling) or (2) any FDA-approved smoking cessation pharmacotherapy (nicotine patch, gum, lozenge, inhaler, or nasal spray; bupropion; or varenicline).

Secondary Outcome Measures

Name	Time	Method
Use of smoking cessation counseling	Past 3 months	Use of telephone or in-person smoking cessation counseling in the past 3 months
7-day point prevalence abstinence from tobacco products	3 month follow-up	tobacco abstinence, defined as self-reported 7-day point prevalence abstinence at 3-month follow-up
30-day point prevalence abstinence from tobacco products	3 month follow-up	Tobacco abstinence, defined as self-reported 30-day point prevalence abstinence at 3-month follow-up
Use of nicotine replacement therapy	Past 3 months	Use of nicotine patch, gum, lozenge, inhaler, or nasal spray in the past 3 months.
Use of any tobacco cessation medication	Past 3 months	Use of any nicotine replacement product, varenicline, or bupropion in the past 3 months in order to quit smoking

Trial Locations

Locations (1)

Revere Health Center; 🇺🇸 Revere, Massachusetts, United States