Trial Outcomes & Findings for Proactive Outreach for Smokers in VA Mental Health (NCT NCT01737281)
NCT ID: NCT01737281
Last Updated: 2019-03-26
Results Overview
The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1938 participants
Primary outcome timeframe
12 months
Results posted on
2019-03-26
Participant Flow
Participant milestones
| Measure |
Proactive Outreach
Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.
Proactive outreach: Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
|
Usual Care
Usual smoking cessation care from clinical staff
Usual care: Usual smoking cessation care from VA clinical staff.
|
|---|---|---|
|
Overall Study
STARTED
|
969
|
969
|
|
Overall Study
COMPLETED
|
603
|
689
|
|
Overall Study
NOT COMPLETED
|
366
|
280
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proactive Outreach for Smokers in VA Mental Health
Baseline characteristics by cohort
| Measure |
Proactive Outreach
n=969 Participants
Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer.
|
Usual Care
n=969 Participants
Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion.
|
Total
n=1938 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
662 Participants
n=99 Participants
|
646 Participants
n=107 Participants
|
1308 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
307 Participants
n=99 Participants
|
323 Participants
n=107 Participants
|
630 Participants
n=206 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
58.9 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
58.6 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
841 Participants
n=99 Participants
|
844 Participants
n=107 Participants
|
1685 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
294 Participants
n=99 Participants
|
309 Participants
n=107 Participants
|
603 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
603 Participants
n=99 Participants
|
595 Participants
n=107 Participants
|
1198 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
44 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
969 Participants
n=99 Participants
|
969 Participants
n=107 Participants
|
1938 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Cotinine samples were obtained by mail from 53/76 people reporting abstinence in the intervention arm and 44/58 people reporting abstinence in the control arm. Note that this reflects a "complete case analysis", only including people for whom outcome data are available.
The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.
Outcome measures
| Measure |
Proactive Outreach
n=53 Participants
Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer.
|
Usual Care
n=44 Participants
Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion.
|
|---|---|---|
|
Number of Participants With Cotinine-Validated Abstinence From Smoking
|
36 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: We used a "complete case" analysis, excluding participants for whom information was not available at 12 month follow-up
At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days
Outcome measures
| Measure |
Proactive Outreach
n=620 Participants
Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer.
|
Usual Care
n=701 Participants
Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion.
|
|---|---|---|
|
Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes
|
119 Participants
|
96 Participants
|
Adverse Events
Intervention Arm
Serious events: 39 serious events
Other events: 0 other events
Deaths: 9 deaths
Control Arm
Serious events: 28 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Intervention Arm
n=969 participants at risk
Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer.
|
Control Arm
n=969 participants at risk
Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion.
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization
|
4.0%
39/969 • Total adverse events were based on the results form 12 month follow-up
Standard adverse even definitions were used
|
2.8%
27/969 • Total adverse events were based on the results form 12 month follow-up
Standard adverse even definitions were used
|
|
General disorders
Life-threating event
|
0.00%
0/969 • Total adverse events were based on the results form 12 month follow-up
Standard adverse even definitions were used
|
0.10%
1/969 • Total adverse events were based on the results form 12 month follow-up
Standard adverse even definitions were used
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place