Trial Outcomes & Findings for Smoking Cessation in Hospitalized Smokers (NCT NCT01289275)
NCT ID: NCT01289275
Last Updated: 2020-02-13
Results Overview
All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Intention to treat analysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1270 participants
Primary outcome timeframe
6-months post enrollment
Results posted on
2020-02-13
Participant Flow
Smokers hospitalized at participating healthcare systems UCSD, Scripps, and UC Davis) between August 2011 and November 2013.
Inclusion criteria: adults, speak and read English or Spanish, smoked prior to hospitalization, cigarette consumption greater than 5 cigarettes per day.
Participant milestones
| Measure |
Telephone Counseling
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
|
Nicotine Patches
Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Telephone Counseling and Nicotine Patches
Nicotine Patches: 8 weeks of nicotine patches at discharge.
Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
|
Brief Hospital Counseling
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
317
|
320
|
317
|
316
|
|
Overall Study
COMPLETED
|
317
|
320
|
317
|
316
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation in Hospitalized Smokers
Baseline characteristics by cohort
| Measure |
Telephone Counseling
n=317 Participants
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
|
Nicotine Patches
n=320 Participants
Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Telephone Counseling and Nicotine Patches
n=317 Participants
Nicotine Patches: 8 weeks of nicotine patches at discharge.
Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
|
Brief Hospital Counseling
n=316 Participants
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Total
n=1270 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
49.9 years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
550 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
720 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
294 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
243 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
976 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
236 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
646 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
77 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
298 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
317 Participants
n=5 Participants
|
320 Participants
n=7 Participants
|
317 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
1270 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6-months post enrollmentPopulation: all randomized subjects
All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Intention to treat analysis.
Outcome measures
| Measure |
Telephone Counseling
n=317 Participants
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
|
Nicotine Patches
n=320 Participants
Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Telephone Counseling and Nicotine Patches
n=317 Participants
Nicotine Patches: 8 weeks of nicotine patches at discharge.
Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
|
Brief Hospital Counseling
n=316 Participants
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
|---|---|---|---|---|
|
Percentage of Participants With 30-day Abstinence
|
18.0 percentage of participants
Interval 13.7 to 22.2
|
23.4 percentage of participants
Interval 18.8 to 28.1
|
22.1 percentage of participants
Interval 17.5 to 26.7
|
18.7 percentage of participants
Interval 14.4 to 23.0
|
SECONDARY outcome
Timeframe: 6-months post enrollmentPopulation: all randomized subjects
Outcome measures
| Measure |
Telephone Counseling
n=317 Participants
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
|
Nicotine Patches
n=320 Participants
Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Telephone Counseling and Nicotine Patches
n=317 Participants
Nicotine Patches: 8 weeks of nicotine patches at discharge.
Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
|
Brief Hospital Counseling
n=316 Participants
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
|---|---|---|---|---|
|
Percentage of Smokers Making a 24-hour Quit Attempt
|
70.0 percentage of participants
Interval 63.8 to 76.3
|
78.9 percentage of participants
Interval 73.5 to 84.3
|
77.6 percentage of participants
Interval 72.0 to 83.2
|
69.7 percentage of participants
Interval 63.6 to 75.8
|
SECONDARY outcome
Timeframe: 6-months post enrollmentOutcome measures
| Measure |
Telephone Counseling
n=317 Participants
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
|
Nicotine Patches
n=320 Participants
Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Telephone Counseling and Nicotine Patches
n=317 Participants
Nicotine Patches: 8 weeks of nicotine patches at discharge.
Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
|
Brief Hospital Counseling
n=316 Participants
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
|---|---|---|---|---|
|
Self-reported Re-hospitalization
|
45 Participants
|
50 Participants
|
53 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 2-months post enrollmentPopulation: all randomized subjects
All participants will receive an assessment Interview 2-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone.
Outcome measures
| Measure |
Telephone Counseling
n=317 Participants
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
|
Nicotine Patches
n=320 Participants
Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Telephone Counseling and Nicotine Patches
n=317 Participants
Nicotine Patches: 8 weeks of nicotine patches at discharge.
Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
|
Brief Hospital Counseling
n=316 Participants
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
|---|---|---|---|---|
|
30-day Abstinence
|
19.6 percentage of participants
Interval 15.2 to 23.9
|
22.5 percentage of participants
Interval 17.9 to 27.1
|
24.0 percentage of participants
Interval 19.3 to 28.7
|
18.4 percentage of participants
Interval 14.1 to 22.6
|
Adverse Events
Telephone Counseling
Serious events: 69 serious events
Other events: 0 other events
Deaths: 8 deaths
Nicotine Patches
Serious events: 77 serious events
Other events: 0 other events
Deaths: 11 deaths
Telephone Counseling and Nicotine Patches
Serious events: 76 serious events
Other events: 0 other events
Deaths: 15 deaths
Brief Hospital Counseling
Serious events: 88 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Telephone Counseling
n=317 participants at risk
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
|
Nicotine Patches
n=320 participants at risk
Nicotine Patches: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
Telephone Counseling and Nicotine Patches
n=317 participants at risk
Nicotine Patches: 8 weeks of nicotine patches at discharge.
Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
|
Brief Hospital Counseling
n=316 participants at risk
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
|
|---|---|---|---|---|
|
General disorders
rehospitalization
|
21.8%
69/317 • Number of events 69 • Data were collected over 7 months, ending with the 7 month post-enrollment evaluation.
Rehospitalization was asked at the time of evaluation.
|
24.1%
77/320 • Number of events 77 • Data were collected over 7 months, ending with the 7 month post-enrollment evaluation.
Rehospitalization was asked at the time of evaluation.
|
24.0%
76/317 • Number of events 76 • Data were collected over 7 months, ending with the 7 month post-enrollment evaluation.
Rehospitalization was asked at the time of evaluation.
|
27.8%
88/316 • Number of events 88 • Data were collected over 7 months, ending with the 7 month post-enrollment evaluation.
Rehospitalization was asked at the time of evaluation.
|
Other adverse events
Adverse event data not reported
Additional Information
Sharon Cummins, Ph.D.
UC San Diego, California Smokers' Helpline
Phone: 8583001046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place