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Clinical Trials/NCT01321944
NCT01321944
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country590 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Dependence
Sponsor
Massachusetts General Hospital
Enrollment
590
Locations
1
Primary Endpoint
proportion of participants who reported using any tobacco dependence treatment during the 3-month study period
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
July 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Use of smoking cessation counseling(Past 3 months)
  • 7-day point prevalence abstinence from tobacco products(3 month follow-up)
  • 30-day point prevalence abstinence from tobacco products(3 month follow-up)
  • Use of nicotine replacement therapy(Past 3 months)
  • Use of any tobacco cessation medication(Past 3 months)

Study Sites (1)

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