Trial Outcomes & Findings for Smoking Cessation Invention in the Emergency Department (ED) (NCT NCT01173653)

NCT ID: NCT01173653

Last Updated: 2012-12-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 199 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2012-12-27

Participant Flow

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.

The targeted patient population were patients presenting to the emergency department who were smokers. There were no restrictions placed on gender, race, or ethnicity.

Participant milestones

Measure	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.
Overall Study STARTED	109	90
Overall Study COMPLETED	56	49
Overall Study NOT COMPLETED	53	41

Reasons for withdrawal

Measure	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.
Overall Study Pts unwilling to provide follow-up	53	41

Baseline Characteristics

Smoking Cessation Invention in the Emergency Department (ED)

Baseline characteristics by cohort

Measure	Standard EM Smoking Cessation Info n=109 Participants Patients discharged from ER receive pamphlet re: smoking cessation	Patients Contact 1-800-QUIT-NOW Before Leaving ED n=90 Participants 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 n=199 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=93 Participants	90 Participants n=4 Participants	199 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	44 years INTER_QUARTILE_RANGE 31, 51 • n=93 Participants	44 years INTER_QUARTILE_RANGE 33, 49 • n=4 Participants	44 years INTER_QUARTILE_RANGE 33, 50 • n=27 Participants
Sex: Female, Male Female	56 Participants n=93 Participants	45 Participants n=4 Participants	101 Participants n=27 Participants
Sex: Female, Male Male	53 Participants n=93 Participants	45 Participants n=4 Participants	98 Participants n=27 Participants
Region of Enrollment United States	109 participants n=93 Participants	90 participants n=4 Participants	199 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 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.

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

Outcome measures

Measure	Control Arm n=56 Participants No intervention given to this ED population of smokers	Intervention Arm n=49 Participants Enrollees put in contact with 1-800-QUIT-NOW line
Smoking Status at Follow up	7 percentage of participants	24 percentage of participants

Adverse Events

Standard EM Smoking Cessation Info

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Contact 1-800-QUIT-NOW Before Leaving ED

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin Heavrin, MD

Vanderbilt University Emergency Medicine Department

Phone: 615-936-0253-

Email: benjamin.heavrin@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place