Direct to Smoker Outreach in a Health Care Setting

NCT01321944 | Completed

• 1 other identifier: 2009P001137
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Use of smoking cessation counseling

  Past 3 months

Study Arms (2)

Usual clinical care

NO INTERVENTION

Usual clinical care provided by health care system

DTS intervention

EXPERIMENTAL

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.

Other: Direct to Smoker Outreach Program

Interventions

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.

Also known as: Nicotine transdermal patch

DTS intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Partners HealthCare, Inc.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Revere Health Center

Revere, Massachusetts, United States

Location

Related Publications (1)

• 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.

  PMID: 22011421 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nancy A Rigotti, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 24, 2011

Record last verified: 2011-03

Locations

US (1)