Direct to Smoker Outreach in a Health Care Setting (DTS)

This study has been completed.
Sponsor:
Collaborators:
Partners HealthCare, Inc.
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01321944
First received: March 22, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Tobacco Dependence
Other: Direct to Smoker Outreach Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A POPULATION-BASED DIRECT-TO-SMOKER OUTREACH OFFERING TOBACCO TREATMENT IN A HEALTH CARE SETTING: A RANDOMIZED CONTROLLED TRIAL

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • proportion of participants who reported using any tobacco dependence treatment during the 3-month study period [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 7-day point prevalence abstinence from tobacco products [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
    tobacco abstinence, defined as self-reported 7-day point prevalence abstinence at 3-month follow-up

  • 30-day point prevalence abstinence from tobacco products [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
    Tobacco abstinence, defined as self-reported 30-day point prevalence abstinence at 3-month follow-up

  • Use of nicotine replacement therapy [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
    Use of nicotine patch, gum, lozenge, inhaler, or nasal spray in the past 3 months.

  • Use of any tobacco cessation medication [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
    Use of any nicotine replacement product, varenicline, or bupropion in the past 3 months in order to quit smoking

  • Use of smoking cessation counseling [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
    Use of telephone or in-person smoking cessation counseling in the past 3 months


Enrollment: 590
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual clinical care
Usual clinical care provided by health care system
Experimental: 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.
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.
Other Name: Nicotine transdermal patch

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321944

Locations
United States, Massachusetts
Revere Health Center
Revere, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Partners HealthCare, Inc.
Investigators
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Rigotti, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01321944     History of Changes
Other Study ID Numbers: 2009P001137
Study First Received: March 22, 2011
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014