Emergency Department Initiated Tobacco Treatment (EDITT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252902
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : January 11, 2017
The Cooper Health System
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
The primary purpose of the study is to refine the intervention protocols for two ED-initiated tobacco interventions and to assess the magnitude of the effect size that can be expected. We expect the intervention groups to have greater sustained abstinence, point-prevalence abstinence, and motivation to change when compared to the treatment as usual group at 1- and 3-month follow-up.

Condition or disease Intervention/treatment Phase
Tobacco Use Behavioral: Behavior change counseling Phase 1 Phase 2

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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

Primary Outcome Measures :
  1. Sustained abstinence (from tobacco)
  2. 7-day Point prevalence abstinence
  3. Any quit attempt >= 24 hours

Secondary Outcome Measures :
  1. Motivation to quit
  2. Treatment engagement

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years old
  • receiving treatment in the ED
  • smoking at least 10 cigarettes daily

Exclusion Criteria:

  • too ill to participate
  • temporary shelter
  • no phone

Information from the National Library of Medicine

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 identifier (NCT number): NCT00252902

United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
The Cooper Health System
Principal Investigator: Edwin D Boudreaux, PhD Cooper University Hospital, UMDNJ-Robert Wood Johnson Medical School

Publications of Results: Identifier: NCT00252902     History of Changes
Other Study ID Numbers: DA-16698-01
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: October 2013

Keywords provided by National Institute on Drug Abuse (NIDA):
tobacco; emergency department; motivation; counseling

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes