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Trial record 48 of 2035 for:    Smoking Cessation

Smoking Cessation Invention in the Emergency Department (ED)

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ClinicalTrials.gov Identifier: NCT01173653
Recruitment Status : Completed
First Posted : August 2, 2010
Results First Posted : November 19, 2012
Last Update Posted : December 27, 2012
Sponsor:
Information provided by (Responsible Party):
Ben Heavrin, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Smoking Cessation
Tobacco Use Cessation
Health Behavior
Intervention Other: Smoking Cessation
Enrollment 199
Recruitment Details 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 The targeted patient population were patients presenting to the emergency department who were smokers. There were no restrictions placed on gender, race, or ethnicity.
Arm/Group Title Standard EM Smoking Cessation Info Patients Contact 1-800-QUIT-NOW Before Leaving ED
Hide Arm/Group Description Patients discharged from ER receive pamphlet re: smoking cessation 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.
Period Title: Overall Study
Started 109 90
Completed 56 49
Not Completed 53 41
Reason Not Completed
Pts unwilling to provide follow-up             53             41
Arm/Group Title Standard EM Smoking Cessation Info Patients Contact 1-800-QUIT-NOW Before Leaving ED Total
Hide Arm/Group Description Patients discharged from ER receive pamphlet re: smoking cessation 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 of all reporting groups
Overall Number of Baseline Participants 109 90 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 90 participants 199 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
109
 100.0%
90
 100.0%
199
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 109 participants 90 participants 199 participants
44
(31 to 51)
44
(33 to 49)
44
(32 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 90 participants 199 participants
Female
56
  51.4%
45
  50.0%
101
  50.8%
Male
53
  48.6%
45
  50.0%
98
  49.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants 90 participants 199 participants
109 90 199
1.Primary Outcome
Title Smoking Status at Follow up
Hide Description Patients enrolled in this study were contacted via phone to assess smoking status. Smoking status was a self-report from each subject. Primary outcome measure is the smoking status of the enrollee at the time of follow-up contact. We calculated the percentage of participants who had stopped smoking at the 6 week follow-up period in each arm
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of subjects enrolled, 56 of the 109 subjects in the control arm and 49 of 90 subjects in the intervention arm were able to be contacted via phone and were willing to provide follow-up data for analysis of smoking status at the 6 week follow-up.
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description:
No intervention given to this ED population of smokers
Enrollees put in contact with 1-800-QUIT-NOW line
Overall Number of Participants Analyzed 56 49
Measure Type: Number
Unit of Measure: percentage of participants
7 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Arm, Intervention Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Chi square
Estimated Value 23.02
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard EM Smoking Cessation Info Patients Contact 1-800-QUIT-NOW Before Leaving ED
Hide Arm/Group Description Patients discharged from ER receive pamphlet re: smoking cessation 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.
All-Cause Mortality
Standard EM Smoking Cessation Info Patients Contact 1-800-QUIT-NOW Before Leaving ED
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard EM Smoking Cessation Info Patients Contact 1-800-QUIT-NOW Before Leaving ED
Affected / at Risk (%) Affected / at Risk (%)
Total   0/109 (0.00%)   0/90 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard EM Smoking Cessation Info Patients Contact 1-800-QUIT-NOW Before Leaving ED
Affected / at Risk (%) Affected / at Risk (%)
Total   0/109 (0.00%)   0/90 (0.00%) 
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.
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-
Responsible Party: Ben Heavrin, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01173653     History of Changes
Other Study ID Numbers: 100411
First Submitted: July 29, 2010
First Posted: August 2, 2010
Results First Submitted: January 9, 2012
Results First Posted: November 19, 2012
Last Update Posted: December 27, 2012