Trial Outcomes & Findings for Treating Low-Income Smokers in the Hospital Emergency Department (NCT NCT01328431)
NCT ID: NCT01328431
Last Updated: 2014-08-04
Results Overview
Biochemical verification means a breathalyzer reading for carbon monoxide.
COMPLETED
NA
780 participants
3 months after enrollment
2014-08-04
Participant Flow
Participant milestones
| Measure |
Standard Care
Subjects receive a brochure for the state's Smokers' Quitline only.
|
SBIRT+NRT
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.
|
|---|---|---|
|
Baseline
STARTED
|
390
|
390
|
|
Baseline
COMPLETED
|
390
|
388
|
|
Baseline
NOT COMPLETED
|
0
|
2
|
|
1 Month (1M)
STARTED
|
390
|
388
|
|
1 Month (1M)
COMPLETED
|
335
|
330
|
|
1 Month (1M)
NOT COMPLETED
|
55
|
58
|
|
3 Month (3M)
STARTED
|
390
|
388
|
|
3 Month (3M)
COMPLETED
|
313
|
316
|
|
3 Month (3M)
NOT COMPLETED
|
77
|
72
|
|
12 Month (12M)
STARTED
|
388
|
386
|
|
12 Month (12M)
COMPLETED
|
304
|
289
|
|
12 Month (12M)
NOT COMPLETED
|
84
|
97
|
Reasons for withdrawal
| Measure |
Standard Care
Subjects receive a brochure for the state's Smokers' Quitline only.
|
SBIRT+NRT
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.
|
|---|---|---|
|
Baseline
Protocol Violation
|
0
|
2
|
|
1 Month (1M)
Lost to Follow-up
|
55
|
58
|
|
3 Month (3M)
Death
|
2
|
2
|
|
3 Month (3M)
Lost to Follow-up
|
75
|
70
|
|
12 Month (12M)
Death
|
2
|
6
|
|
12 Month (12M)
Lost to Follow-up
|
82
|
91
|
Baseline Characteristics
Treating Low-Income Smokers in the Hospital Emergency Department
Baseline characteristics by cohort
| Measure |
Standard Care
n=390 Participants
Subjects receive a brochure for the state's Smokers' Quitline only.
|
SBIRT+NRT
n=388 Participants
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.
|
Total
n=778 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
384 Participants
n=5 Participants
|
376 Participants
n=7 Participants
|
760 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after enrollmentPopulation: This is the # of participants in each group.
Biochemical verification means a breathalyzer reading for carbon monoxide.
Outcome measures
| Measure |
Standard Care
n=388 Participants
Subjects receive a brochure for the state's Smokers' Quitline only.
|
SBIRT+NRT
n=386 Participants
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.
|
|---|---|---|
|
Biochemical Verification of Tobacco Abstinence
|
19 participants
Interval 1.0 to 30.0
|
47 participants
Interval 1.0 to 33.0
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: This is the # of participants in each group.
Questionnaires to assess self reported tobacco abstinence
Outcome measures
| Measure |
Standard Care
n=388 Participants
Subjects receive a brochure for the state's Smokers' Quitline only.
|
SBIRT+NRT
n=386 Participants
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.
|
|---|---|---|
|
Self-report of Tobacco Abstinence or Reduction
|
34 participants
|
63 participants
|
SECONDARY outcome
Timeframe: 1 month post enrollmentself-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month post enrollmentA version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post enrollmentself-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post enrollmentA version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post enrollmentA version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
Outcome measures
Outcome data not reported
Adverse Events
Standard Care
SBIRT+NRT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place