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

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct to Smoker Outreach Program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Revere Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual clinical care

DTS intervention

Arm Description

Usual clinical care provided by health care system

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

7-day point prevalence abstinence from tobacco products
tobacco abstinence, defined as self-reported 7-day point prevalence abstinence at 3-month follow-up
30-day point prevalence abstinence from tobacco products
Tobacco abstinence, defined as self-reported 30-day point prevalence abstinence at 3-month follow-up
Use of nicotine replacement therapy
Use of nicotine patch, gum, lozenge, inhaler, or nasal spray in the past 3 months.
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
Use of smoking cessation counseling
Use of telephone or in-person smoking cessation counseling in the past 3 months

Full Information

First Posted
March 22, 2011
Last Updated
March 22, 2011
Sponsor
Massachusetts General Hospital
Collaborators
Partners HealthCare, Inc., National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01321944
Brief Title
Direct to Smoker Outreach in a Health Care Setting
Acronym
DTS
Official Title
A POPULATION-BASED DIRECT-TO-SMOKER OUTREACH OFFERING TOBACCO TREATMENT IN A HEALTH CARE SETTING: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Partners HealthCare, Inc., National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual clinical care
Arm Type
No Intervention
Arm Description
Usual clinical care provided by health care system
Arm Title
DTS intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Direct to Smoker Outreach Program
Other Intervention Name(s)
Nicotine transdermal patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of participants who reported using any tobacco dependence treatment during the 3-month study period
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
7-day point prevalence abstinence from tobacco products
Description
tobacco abstinence, defined as self-reported 7-day point prevalence abstinence at 3-month follow-up
Time Frame
3 month follow-up
Title
30-day point prevalence abstinence from tobacco products
Description
Tobacco abstinence, defined as self-reported 30-day point prevalence abstinence at 3-month follow-up
Time Frame
3 month follow-up
Title
Use of nicotine replacement therapy
Description
Use of nicotine patch, gum, lozenge, inhaler, or nasal spray in the past 3 months.
Time Frame
Past 3 months
Title
Use of any tobacco cessation medication
Description
Use of any nicotine replacement product, varenicline, or bupropion in the past 3 months in order to quit smoking
Time Frame
Past 3 months
Title
Use of smoking cessation counseling
Description
Use of telephone or in-person smoking cessation counseling in the past 3 months
Time Frame
Past 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Rigotti, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Revere Health Center
City
Revere
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22011421
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.
Results Reference
derived

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Direct to Smoker Outreach in a Health Care Setting

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