Emergency Department Initiated Tobacco Treatment (EDITT)
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|ClinicalTrials.gov Identifier: NCT00252902|
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use||Behavioral: Behavior change counseling||Phase 1 Phase 2|
Most surveys of emergency physicians indicate that smoking cessation counseling rarely occurs in routine clinical practice. Prochazka and colleagues (1996) studied 196 members of the Colorado Chapter of the American College of Emergency Physicians and found that only 27% reported routinely asking patients to quit smoking. We conducted a similar survey study and found that only 19% of emergency physicians practicing in an urban teaching hospital reported that they routinely counseled their tobacco using patients to quit. A study of 63 adult smokers presenting to the ED with symptoms of acute respiratory illness found that only 9% were offered any assistance with quitting (Bock et al., 2001). Clearly, more research was needed to investigate smoking interventions initiated in the ED.
Currently, not much is known about how best to intervene with smokers in the ED. This proposal describes a pilot study designed to explore two interventions. Research that expands our knowledge of ED-initiated tobacco interventions has tremendous public health potential, especially for the under-served populations that are over-represented in the ED patient population.This study is designed primarily to yield effects size parameters so a larger RCT can be planned. For this reason, it is not powered specifically to detect a given difference, but, rather, simply to provide an idea of the size of the effect so we can determine how many subjects would be needed in a future trial in order to demonstrate statistical significance and clinical utility. It will also be used to refine the study design, protocols, and treatment manuals for the future trial.
This study will be a randomized, single-blind, controlled trial that will compared two types of ED-initiated tobacco treatment to treatment-as-usual. 75 ED patients who meet all inclusion and exclusion criteria will be randomly assigned to one of three groups using a 2:2:1 ratio: Group One: Enhanced Care (n=30), Group Two: Dynamic Referral (n=30), or Group Three: Clinic Referral (n=15). This assignment ratio is being used to maximize experience with the treatments. The two interventions will be delivered by trained counselors and are described below. Baseline measures of smoking and other related variables will be taken during the ED visit. An interviewer blind to study group assignment will conduct follow-up assessments via telephone at 1- and 3-months after the ED visit. We expect a 25% attrition, yielding follow-up data at 3-months on 23, 23, and 11 patients, respectively, for each Group.
Primary outcomes will include: sustained abstinence from the ED visit to the follow-up time periods and 7-day point prevalence abstinence. Secondary outcomes will be: presence of a quit attempt >= 24 hours and readiness to change.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Emergency Department Initiated Tobacco Treatment (EDITT)|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2007|
- Sustained abstinence (from tobacco)
- 7-day Point prevalence abstinence
- Any quit attempt >= 24 hours
- Motivation to quit
- Treatment engagement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252902
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|Principal Investigator:||Edwin D Boudreaux, PhD||Cooper University Hospital, UMDNJ-Robert Wood Johnson Medical School|