Trial Outcomes & Findings for Proactive Tobacco Treatment for Veterans (NCT NCT00608426)
NCT ID: NCT00608426
Last Updated: 2015-04-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6400 participants
Primary outcome timeframe
12 months after randomization
Results posted on
2015-04-24
Participant Flow
At the time of the baseline survey, 1277 subjects were excluded for not meeting eligiblitiy criteria: 428 declined to participate; 201 were misclassfied as cigarette smokers (never used cigarettes or smokeless tobacco user); 444 were former smokers (rather than current smokers); 179 had incorrect mailing addresses; and 25 were deceased.
Participant milestones
| Measure |
Usual Care
Group who can elect to receive reactive (usual) care for smoking cessation.
|
Proactive Care
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
|
|---|---|---|
|
Overall Study
STARTED
|
2604
|
2519
|
|
Overall Study
COMPLETED
|
1768
|
1614
|
|
Overall Study
NOT COMPLETED
|
836
|
905
|
Reasons for withdrawal
| Measure |
Usual Care
Group who can elect to receive reactive (usual) care for smoking cessation.
|
Proactive Care
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
|
|---|---|---|
|
Overall Study
Death
|
32
|
36
|
|
Overall Study
Lost to Follow-up
|
485
|
521
|
|
Overall Study
refused, health issues, wrong address
|
319
|
348
|
Baseline Characteristics
Proactive Tobacco Treatment for Veterans
Baseline characteristics by cohort
| Measure |
Usual Care
n=2604 Participants
Group who can elect to receive reactive (usual) care for smoking cessation.
|
Proactive Care
n=2519 Participants
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
|
Total
n=5123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2446 Participants
n=5 Participants
|
2378 Participants
n=7 Participants
|
4824 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1713 participants
n=5 Participants
|
1603 participants
n=7 Participants
|
3316 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
568 participants
n=5 Participants
|
595 participants
n=7 Participants
|
1163 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
120 participants
n=5 Participants
|
111 participants
n=7 Participants
|
231 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
203 participants
n=5 Participants
|
210 participants
n=7 Participants
|
413 participants
n=5 Participants
|
|
Married
Married
|
1156 participants
n=5 Participants
|
1108 participants
n=7 Participants
|
2264 participants
n=5 Participants
|
|
Married
Not Married
|
1448 participants
n=5 Participants
|
1411 participants
n=7 Participants
|
2859 participants
n=5 Participants
|
|
Distance to the VA hospital, miles
<5
|
212 participants
n=5 Participants
|
174 participants
n=7 Participants
|
386 participants
n=5 Participants
|
|
Distance to the VA hospital, miles
5-10
|
472 participants
n=5 Participants
|
456 participants
n=7 Participants
|
928 participants
n=5 Participants
|
|
Distance to the VA hospital, miles
>10-25
|
698 participants
n=5 Participants
|
662 participants
n=7 Participants
|
1360 participants
n=5 Participants
|
|
Distance to the VA hospital, miles
>25-50
|
425 participants
n=5 Participants
|
436 participants
n=7 Participants
|
861 participants
n=5 Participants
|
|
Distance to the VA hospital, miles
>50
|
797 participants
n=5 Participants
|
791 participants
n=7 Participants
|
1588 participants
n=5 Participants
|
|
Smoking related cancer
Cancer
|
57 participants
n=5 Participants
|
71 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Smoking related cancer
No cancer
|
2547 participants
n=5 Participants
|
2448 participants
n=7 Participants
|
4995 participants
n=5 Participants
|
|
Smoking related cardiovascular disease
Yes
|
703 participants
n=5 Participants
|
677 participants
n=7 Participants
|
1380 participants
n=5 Participants
|
|
Smoking related cardiovascular disease
No
|
1901 participants
n=5 Participants
|
1842 participants
n=7 Participants
|
3743 participants
n=5 Participants
|
|
Smoking related respiratory disease
Yes
|
500 participants
n=5 Participants
|
458 participants
n=7 Participants
|
958 participants
n=5 Participants
|
|
Smoking related respiratory disease
No
|
2104 participants
n=5 Participants
|
2061 participants
n=7 Participants
|
4165 participants
n=5 Participants
|
|
Presence of psychiatric co-morbidity
None
|
1383 participants
n=5 Participants
|
1335 participants
n=7 Participants
|
2718 participants
n=5 Participants
|
|
Presence of psychiatric co-morbidity
One
|
612 participants
n=5 Participants
|
605 participants
n=7 Participants
|
1217 participants
n=5 Participants
|
|
Presence of psychiatric co-morbidity
Two or more
|
609 participants
n=5 Participants
|
579 participants
n=7 Participants
|
1188 participants
n=5 Participants
|
|
Depression
Yes
|
565 participants
n=5 Participants
|
552 participants
n=7 Participants
|
1117 participants
n=5 Participants
|
|
Depression
No
|
2039 participants
n=5 Participants
|
1967 participants
n=7 Participants
|
4006 participants
n=5 Participants
|
|
Anxiety Disorder
Yes
|
247 participants
n=5 Participants
|
289 participants
n=7 Participants
|
536 participants
n=5 Participants
|
|
Anxiety Disorder
No
|
2357 participants
n=5 Participants
|
2230 participants
n=7 Participants
|
4587 participants
n=5 Participants
|
|
Post-traumatic stress disorder
Yes
|
216 participants
n=5 Participants
|
216 participants
n=7 Participants
|
432 participants
n=5 Participants
|
|
Post-traumatic stress disorder
No
|
2388 participants
n=5 Participants
|
2303 participants
n=7 Participants
|
4691 participants
n=5 Participants
|
|
Serious mental illness
Yes
|
177 participants
n=5 Participants
|
161 participants
n=7 Participants
|
338 participants
n=5 Participants
|
|
Serious mental illness
No
|
2427 participants
n=5 Participants
|
2358 participants
n=7 Participants
|
4785 participants
n=5 Participants
|
|
Other psychiatric disorder
Yes
|
430 participants
n=5 Participants
|
416 participants
n=7 Participants
|
846 participants
n=5 Participants
|
|
Other psychiatric disorder
No
|
2174 participants
n=5 Participants
|
2103 participants
n=7 Participants
|
4277 participants
n=5 Participants
|
|
Other substance use disorder
Yes
|
534 participants
n=5 Participants
|
481 participants
n=7 Participants
|
1015 participants
n=5 Participants
|
|
Other substance use disorder
No
|
2070 participants
n=5 Participants
|
2038 participants
n=7 Participants
|
4108 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after randomizationPopulation: Out of the 3382 completed follow-up surveys, 3307 completed the primary smoking-abstinence outcome.
Outcome measures
| Measure |
Usual Care
n=1734 Participants
Group who can elect to receive reactive (usual) care for smoking cessation.
|
Proactive Care
n=1573 Participants
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
|
|---|---|---|
|
Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence
|
10.9 percentage of participants
|
13.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 months after randomizationOutcome measures
| Measure |
Usual Care
n=1734 Participants
Group who can elect to receive reactive (usual) care for smoking cessation.
|
Proactive Care
n=1573 Participants
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
|
|---|---|---|
|
Treatment Utilization Rates for Counseling and/or Pharmacotherapy
Telephone counseling
|
2.2 percentage of participants
|
12.7 percentage of participants
|
|
Treatment Utilization Rates for Counseling and/or Pharmacotherapy
In-person counseling
|
6 percentage of participants
|
5.5 percentage of participants
|
|
Treatment Utilization Rates for Counseling and/or Pharmacotherapy
Used medication
|
39 percentage of participants
|
41.1 percentage of participants
|
|
Treatment Utilization Rates for Counseling and/or Pharmacotherapy
Combination counseling and medication
|
5.1 percentage of participants
|
12.8 percentage of participants
|
|
Treatment Utilization Rates for Counseling and/or Pharmacotherapy
Attended VA smoking cessation clinic
|
3.4 percentage of participants
|
3.2 percentage of participants
|
|
Treatment Utilization Rates for Counseling and/or Pharmacotherapy
Received VA smoking cessation medication
|
29.5 percentage of participants
|
34.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 months after randomizatoinPopulation: Out of the 3382 completed follow-up surveys, 3056 completed the 7-day point prevalence outcome.
Outcome measures
| Measure |
Usual Care
n=1603 Participants
Group who can elect to receive reactive (usual) care for smoking cessation.
|
Proactive Care
n=1453 Participants
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
|
|---|---|---|
|
7-day Point Prevalence Abstinence
|
15.1 percentage of participants
|
17.1 percentage of participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proactive Care
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
Steven Fu, Director
Center for Chronic Disease Outcomes Research
Phone: 612-467-1979
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place