Smoking Cessation Invention in the Emergency Department (ED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ben Heavrin, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01173653
First received: July 29, 2010
Last updated: December 19, 2012
Last verified: December 2012
Results First Received: January 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Smoking Cessation
Tobacco Use Cessation
Health Behavior
Intervention: Other: Smoking Cessation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 199 subjects were recruited during June and July 2010. 90 subjects were randomized to the intervention arm and 109 were randomized to the control arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The targeted patient population were patients presenting to the emergency department who were smokers. There were no restrictions placed on gender, race, or ethnicity.

Reporting Groups
  Description
Standard EM Smoking Cessation Info Patients discharged from ER receive pamphlet re: smoking cessation
Patients Contact 1-800-QUIT-NOW Before Leaving ED Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.

Participant Flow:   Overall Study
    Standard EM Smoking Cessation Info     Patients Contact 1-800-QUIT-NOW Before Leaving ED  
STARTED     109     90  
COMPLETED     56     49  
NOT COMPLETED     53     41  
Pts unwilling to provide follow-up                 53                 41  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard EM Smoking Cessation Info Patients discharged from ER receive pamphlet re: smoking cessation
Patients Contact 1-800-QUIT-NOW Before Leaving ED Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
Total Total of all reporting groups

Baseline Measures
    Standard EM Smoking Cessation Info     Patients Contact 1-800-QUIT-NOW Before Leaving ED     Total  
Number of Participants  
[units: participants]
  109     90     199  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     109     90     199  
>=65 years     0     0     0  
Age  
[units: years]
Median ( Inter-Quartile Range )
  44  
  ( 31 to 51 )  
  44  
  ( 33 to 49 )  
  44  
  ( 32 to 50 )  
Gender  
[units: participants]
     
Female     56     45     101  
Male     53     45     98  
Region of Enrollment  
[units: participants]
     
United States     109     90     199  



  Outcome Measures

1.  Primary:   Smoking Status at Follow up   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a preliminary study with a convenience sample of patients at a single academic medical center. A larger multicenter trial targeting consecutive ED patients who smoke will be essential to validate the applicability of our findings.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Benjamin Heavrin, MD
Organization: Vanderbilt University Emergency Medicine Department
phone: 615-936-0253-
e-mail: benjamin.heavrin@vanderbilt.edu


No publications provided


Responsible Party: Ben Heavrin, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01173653     History of Changes
Other Study ID Numbers: 100411
Study First Received: July 29, 2010
Results First Received: January 9, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration