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NCT01321944 · ClinicalTrials.gov registry record · NA
Direct to Smoker Outreach in a Health Care Setting
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 590
- Enrollment target
NCT01321944: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01321944 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 590 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01321944, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 590 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- OTHER Direct to Smoker Outreach Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 590 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-07 |
| Phase | NA |
What the finished NCT01321944 record still lists
NCT01321944 is an interventional study that assigns participants to a tested intervention. The registered 590 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Direct to Smoker Outreach Program is the first listed.
NCT01321944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01321944 about?
NCT01321944 is a clinical study titled "Direct to Smoker Outreach in a Health Care Setting". 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 smo...
What is the current status of trial NCT01321944?
This trial is currently completed. It is a NA study. The enrollment target is 590 participants. The study started on 2009-07. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01321944?
The interventions under investigation include: Direct to Smoker Outreach Program (OTHER).
Who is sponsoring clinical trial NCT01321944?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01321944's enrollment target sits among peer trials
590 175th of 2000 higher than 1,825 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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