Direct to Smoker Outreach in a Health Care Setting

Tobacco Dependence Clinical Trial

— DTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321944
• Other study ID #: 2009P001137
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: March 22, 2011
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Other:
• Direct to Smoker Outreach Program
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.

Locations

Country	Name	City	State
United States	Revere Health Center	Revere	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI), Partners HealthCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of participants who reported using any tobacco dependence treatment during the 3-month study period	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).	3 months	No
Secondary	7-day point prevalence abstinence from tobacco products	tobacco abstinence, defined as self-reported 7-day point prevalence abstinence at 3-month follow-up	3 month follow-up	No
Secondary	30-day point prevalence abstinence from tobacco products	Tobacco abstinence, defined as self-reported 30-day point prevalence abstinence at 3-month follow-up	3 month follow-up	No
Secondary	Use of nicotine replacement therapy	Use of nicotine patch, gum, lozenge, inhaler, or nasal spray in the past 3 months.	Past 3 months	No
Secondary	Use of any tobacco cessation medication	Use of any nicotine replacement product, varenicline, or bupropion in the past 3 months in order to quit smoking	Past 3 months	No
Secondary	Use of smoking cessation counseling	Use of telephone or in-person smoking cessation counseling in the past 3 months	Past 3 months	No