Clinical trial NCT01321944: Direct to Smoker Outreach in a Health Care Setting
Official title: A POPULATION-BASED DIRECT-TO-SMOKER OUTREACH OFFERING TOBACCO TREATMENT IN A HEALTH CARE SETTING: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Partners HealthCare, Inc.
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-03-24
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: proportion of participants who reported using any tobacco dependence treatment during the 3-month study period
timeFrame: 3 months
Secondary outcomes:
measure: 7-day point prevalence abstinence from tobacco products
timeFrame: 3 month follow-up
measure: 30-day point prevalence abstinence from tobacco products
timeFrame: 3 month follow-up
measure: Use of nicotine replacement therapy
timeFrame: Past 3 months
measure: Use of any tobacco cessation medication
timeFrame: Past 3 months
measure: Use of smoking cessation counseling
timeFrame: Past 3 months
Other outcomes:
Locations:
city: Revere
country: United States
facility: Revere Health Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rigotti NA, Bitton A, Kelley JK, Hoeppner BB, Levy DE, Mort E. Offering population-based tobacco treatment in a healthcare setting: a randomized controlled trial. Am J Prev Med. 2011 Nov;41(5):498-503. doi: 10.1016/j.amepre.2011.07.022.