Direct to Smoker Outreach in a Health Care Setting

NCT ID: NCT01321944

Last Updated: 2011-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 590 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual clinical care

Usual clinical care provided by health care system

Group Type: NO_INTERVENTION

No interventions assigned to this group

DTS intervention

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.

Group Type: EXPERIMENTAL

Direct to Smoker Outreach Program

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Nicotine transdermal patch

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Partners HealthCare, Inc.

INDUSTRY

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

Nancy A Rigotti, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Revere Health Center

Revere, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22011421 (View on PubMed)

Other Identifiers

2009P001137

Identifier Type: -

Identifier Source: org_study_id