Emergency Department Initiated Tobacco Treatment (EDITT)

This study has been completed.
Sponsor:
Collaborator:
The Cooper Health System
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00252902
First received: November 11, 2005
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Tobacco Use
Behavioral: Behavior change counseling
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Emergency Department Initiated Tobacco Treatment (EDITT)

Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Secondary Outcome Measures:
  • Motivation to quit
  • Treatment engagement

Estimated Enrollment: 75
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252902

Locations
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
Investigators
Principal Investigator: Edwin D Boudreaux, PhD Cooper University Hospital, UMDNJ-Robert Wood Johnson Medical School
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00252902     History of Changes
Other Study ID Numbers: DA-16698-01, DA-16698-01
Study First Received: November 11, 2005
Last Updated: October 30, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014