Trial Outcomes & Findings for Telephone Care Coordination for Smokers in VA Mental Health Clinics (NCT NCT00724308)
NCT ID: NCT00724308
Last Updated: 2020-11-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
577 participants
Primary outcome timeframe
6 months after enrollment
Results posted on
2020-11-17
Participant Flow
Participant milestones
| Measure |
Arm 1 - VA Counselling
Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Arm 2 - Quitline Counseling
Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state "Quitline" for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
|---|---|---|
|
Overall Study
STARTED
|
270
|
307
|
|
Overall Study
COMPLETED
|
190
|
210
|
|
Overall Study
NOT COMPLETED
|
80
|
97
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Care Coordination for Smokers in VA Mental Health Clinics
Baseline characteristics by cohort
| Measure |
Arm 1 - VA Counseling
n=270 Participants
Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Arm 2 - Quitline Counseling
n=307 Participants
Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state "Quitline" for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Total
n=577 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12 • n=93 Participants
|
54 years
STANDARD_DEVIATION 12 • n=4 Participants
|
54 years
STANDARD_DEVIATION 12 • n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
248 Participants
n=93 Participants
|
286 Participants
n=4 Participants
|
534 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
92 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
206 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=93 Participants
|
169 Participants
n=4 Participants
|
320 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 months after enrollmentOutcome measures
| Measure |
Arm 1 - VA Counseling
n=190 Participants
Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Arm 2 - Quitline Counseling
n=210 Participants
Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state "Quitline" for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
|---|---|---|
|
Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)
|
49 participants
|
38 participants
|
SECONDARY outcome
Timeframe: 2 months after enrollmentOutcome measures
| Measure |
Arm 1 - VA Counseling
n=211 Participants
Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Arm 2 - Quitline Counseling
n=232 Participants
Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state "Quitline" for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
|---|---|---|
|
30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)
|
38 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 2 and 6 months after enrollmentOutcome measures
| Measure |
Arm 1 - VA Counseling
n=270 Participants
Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Arm 2 - Quitline Counseling
n=307 Participants
Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state "Quitline" for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
|---|---|---|
|
Quit Attempt Rate
2-months
|
137 Participants
|
169 Participants
|
|
Quit Attempt Rate
6-months
|
156 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: 2 and 6 months after enrollmentOutcome measures
| Measure |
Arm 1 - VA Counseling
n=270 Participants
Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Arm 2 - Quitline Counseling
n=307 Participants
Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state "Quitline" for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
|---|---|---|
|
Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)
NRT - 6 months
|
124 Participants
|
157 Participants
|
|
Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)
Bupropion - 6 months
|
243 Participants
|
269 Participants
|
SECONDARY outcome
Timeframe: Quarterly after study implementationPopulation: Participants could receive more than one type of treatment, therefore counts do not necessarily sum to the total number of participants.
Outcome measures
| Measure |
Arm 1 - VA Counseling
n=270 Participants
Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
Arm 2 - Quitline Counseling
n=307 Participants
Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state "Quitline" for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
|
|---|---|---|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Counselling - 6 months : NY Harbor HCS
|
75 Participants
|
35 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Counselling - 6 months : Bedford
|
0 Participants
|
3 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Counselling - 6 months : NJ HCS
|
22 Participants
|
20 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Counselling - 6 months : Bronx
|
18 Participants
|
14 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Counselling - 6 months : Providence
|
3 Participants
|
8 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Counselling - 6 months : White River Junction
|
10 Participants
|
8 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
NRT - 6 months : NY Harbor HCS
|
83 Participants
|
78 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
NRT - 6 months : Bedford
|
0 Participants
|
3 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
NRT - 6 months : NJ HCS
|
20 Participants
|
29 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
NRT - 6 months : Bronx
|
19 Participants
|
18 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
NRT - 6 months : Providence
|
7 Participants
|
7 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
NRT - 6 months : White River Junction
|
17 Participants
|
15 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Bupropion - 6 months : NY Harbor HCS
|
16 Participants
|
18 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Bupropion - 6 months : Bedford
|
0 Participants
|
1 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Bupropion - 6 months : NJ HCS
|
6 Participants
|
7 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Bupropion - 6 months : Bronx
|
4 Participants
|
6 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Bupropion - 6 months : Providence
|
0 Participants
|
1 Participants
|
|
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Bupropion - 6 months : White River Junction
|
1 Participants
|
5 Participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place