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OpenTrials
Completed

NCT Number: NCT01321944

Direct to Smoker Outreach in a Health Care Setting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Revere Health Center

Revere, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct to Smoker Outreach Program

Other

Intervention group participants will be sent 3 letters at monthly intervals signed by the participant's PCP, encouraging the smoker to quit, and offering a free telephone consultation by Partners' Tobacco Treatment Coordinator (TTC). Participants can respond to the treatment offer by calling or emailing the TTC, who will provide a 15-minute consultation following the "5A" strategy recommended by the US Public Health Service's clinical guideline and help smokers access treatment by (1) offering a free 4-week supply of 21mg nicotine patches sent by secure mailing to their home (refillable once for a total of 8 weeks), (2) helping smokers obtain prescriptions from their PCP for other FDA-approved smoking cessation medication, (3) using a fax-referral system to facilitate connection to free multi-session counseling from the Massachusetts Smokers Quitline, and (4) referring to local in-person counseling programs.

Other names: Nicotine transdermal patch

Primary outcomes

  1. proportion of participants who reported using any tobacco dependence treatment during the 3-month study period

    Time frame: 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 outcomes

  1. 7-day point prevalence abstinence from tobacco products

    Time frame: 3 month follow-up

    tobacco abstinence, defined as self-reported 7-day point prevalence abstinence at 3-month follow-up

  2. 30-day point prevalence abstinence from tobacco products

    Time frame: 3 month follow-up

    Tobacco abstinence, defined as self-reported 30-day point prevalence abstinence at 3-month follow-up

  3. Use of nicotine replacement therapy

    Time frame: Past 3 months

    Use of nicotine patch, gum, lozenge, inhaler, or nasal spray in the past 3 months.

  4. Use of any tobacco cessation medication

    Time frame: Past 3 months

    Use of any nicotine replacement product, varenicline, or bupropion in the past 3 months in order to quit smoking

  5. Use of smoking cessation counseling

    Time frame: Past 3 months

    Use of telephone or in-person smoking cessation counseling in the past 3 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Partners HealthCare, Inc.

Registry information

Official study title

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

Acronym: DTS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2011
Registry last updated
Mar 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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