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Completed

NCT Number: NCT00252902

Emergency Department Initiated Tobacco Treatment (EDITT)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cooper University Hospital

Camden, New Jersey, 08103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavior change counseling

Behavioral

Primary outcomes

  1. Sustained abstinence (from tobacco)

  2. 7-day Point prevalence abstinence

  3. Any quit attempt >= 24 hours

Secondary outcomes

  1. Motivation to quit

  2. Treatment engagement

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • The Cooper Health System

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Nov 15, 2005
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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