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NCT01156610 · ClinicalTrials.gov registry record · NA

Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
706
Enrollment target

NCT01156610: Completed NA study, sponsored by Brigham and Women's Hospital.

NCT01156610 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 706 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01156610, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
706 participants
Enrollment target

Study Summary

The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care. Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively. Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.

Primary Outcome

The difference between intervention and control patients ("smokers") who report nine months after randomization that they are now quitters (i.e., that they have not smoked for the past seven days but did smoke on enrollment). Self-reported smoking status has established validity when compared with measured serum cotinine levels and yields similar population prevalence estimates.

Interventions

  • BEHAVIORAL Tobacco Treatment

Trial Details

FieldValue
Enrollment Target 706 participants
Start Date 2011-11
Est. Completion 2014-03
Phase NA
Brigham and Women's Hospital

937 total trials

What the finished NCT01156610 record still lists

NCT01156610 is an interventional study that assigns participants to a tested intervention. The registered 706 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 (50% lower).

The record links to 0 conditions, and to 1 intervention - of which Tobacco Treatment is the first listed.

NCT01156610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01156610 about?

NCT01156610 is a clinical study titled "Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations". The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free ...

What is the current status of trial NCT01156610?

This trial is currently completed. It is a NA study. The enrollment target is 706 participants. The study started on 2011-11. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01156610?

The interventions under investigation include: Tobacco Treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT01156610?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01156610's enrollment target sits among peer trials

706 148th of 2000 higher than 1,853 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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Source: ClinicalTrials.gov NCT01156610, the US trial registry maintained by the National Library of Medicine. NCT01156610 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.