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Clinical Trial Summary

Health care systems are key channels for delivering tobacco cessation treatment to the smokers in a population. A population-based approach could complement office-based care and offload busy clinicians. The project will conduct population-based proactive outreach to current smokers in a health care system's primary care practices and randomize smokers who respond to the outreach to 3 groups: 2 alternative evidence-based cessation resources or to usual care.

Specific Aims:

Aim 1: To determine the feasibility and reach of the program

Aim 2a: To determine whether the 2 intervention arms combined increase the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up compared to those randomized to usual clinical care.

Aim 2b: To determine whether each of the two intervention arms increases the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up, compared to those receiving usual clinical care.


Clinical Trial Description

Health care systems are key channels for delivering tobacco cessation treatment to the smokers in a population. Current health care system approaches require busy clinicians with many competing demands on their time to initiate treatment in the course of clinical encounter. A population-based approach is an alternative that could complement office-based care and offload busy clinicians. The ongoing evolution of the health care system is making this more feasible with adoption of electronic health records (EHR) that document patients' smoking status in a coded field. This facilitates the creation of a registry of smokers who can be offered tobacco treatment proactively. However, the optimal way to implement a proactive population health strategy for tobacco users is unclear.

The goal of the project is to implement a population-based proactive outreach program to current smokers in a health care system's primary care practices. The program will

1. Proactively contact smokers independent of their health care visits and

2. Connect smokers who respond to evidence-based tobacco cessation resources available in the health care system and/or community.

The study aims of the study are to:

Aim 1: To determine the feasibility and reach of the program.

Aim 2a: To determine whether the two intervention arms combined increase the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up, compared to those receiving usual clinical care.

Aim 2b: To determine whether each of the two interventions increases the proportion of smokers who use tobacco cessation treatment over a 6-month follow-up, compared to those receiving usual clinical care.

Exploratory aim: To compare the 7-day point prevalence smoking cessation rate in each intervention arm to usual care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03612895
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date August 2017

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