Smoking
Conditions
Keywords
Smoking, Smoking Cessation, Tobacco, Mental Health
Brief summary
The purpose of this study is to evaluate whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics.
Detailed description
Smoking is the leading preventable cause of death in the United States and is a particular problem among VA users and among persons with a diagnosed mental illness. The prevalence of smoking among VA mental health patients has remained high, in part because smoking cessation treatment rates have remained low. Telephone-based counseling represents the most feasible approach to increasing smoking cessation treatment among VA patients. The approach used in this study has been used very effectively in a primary care-based population that includes a large percentage of mental health patients. This project would target the program specifically at patients seen in VA Mental Health Clinics.
Interventions
OTHERTelephone Care Coordination
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 TeleQuit MH study counselors; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
OTHERTelephone 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) proactive multi-call counseling from the patient's state Quitline; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smokers who are referred from Mental Health Clinics in VA VISNs 1 and 3. * Patients must have access to a telephone and a regular mailing address.
Exclusion criteria
* No access to a telephone * no mailing address * not receiving care from a VISN 1 or VISN 3 Mental Health provider
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) | 6 months after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment) | 2 months after enrollment |
| Quit Attempt Rate | 2 and 6 months after enrollment |
| Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) | 2 and 6 months after enrollment |
| VA Site-level Performance Rates on the VA Tobacco Performance Measures | Quarterly after study implementation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - VA Counseling 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. | 270 |
| 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. | 307 |
| Total | 577 |
Baseline characteristics
| Characteristic | Arm 2 - Quitline Counseling | Total | Arm 1 - VA Counseling |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 114 Participants | 206 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 37 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 169 Participants | 320 Participants | 151 Participants |
| Sex: Female, Male Female | 21 Participants | 43 Participants | 22 Participants |
| Sex: Female, Male Male | 286 Participants | 534 Participants | 248 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 270 | 0 / 307 |
| serious Total, serious adverse events | 0 / 270 | 0 / 307 |
Outcome results
Primary
Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)
Time frame: 6 months after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - VA Counseling | Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) | 49 participants |
| Arm 2 - Quitline Counseling | Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) | 38 participants |
Secondary
30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)
Time frame: 2 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 - VA Counseling | 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment) | 38 Participants |
| Arm 2 - Quitline Counseling | 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment) | 32 Participants |
Secondary
Quit Attempt Rate
Time frame: 2 and 6 months after enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 - VA Counseling | Quit Attempt Rate | 2-months | 137 Participants |
| Arm 1 - VA Counseling | Quit Attempt Rate | 6-months | 156 Participants |
| Arm 2 - Quitline Counseling | Quit Attempt Rate | 2-months | 169 Participants |
| Arm 2 - Quitline Counseling | Quit Attempt Rate | 6-months | 165 Participants |
Secondary
Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)
Time frame: 2 and 6 months after enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 - VA Counseling | Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) | NRT - 6 months | 124 Participants |
| Arm 1 - VA Counseling | Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) | Bupropion - 6 months | 243 Participants |
| Arm 2 - Quitline Counseling | Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) | NRT - 6 months | 157 Participants |
| Arm 2 - Quitline Counseling | Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) | Bupropion - 6 months | 269 Participants |
Secondary
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Time frame: Quarterly after study implementation
Population: Participants could receive more than one type of treatment, therefore counts do not necessarily sum to the total number of participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : NY Harbor HCS | 75 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : Bedford | 0 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : NJ HCS | 22 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : Bronx | 18 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : Providence | 3 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : White River Junction | 10 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : NY Harbor HCS | 83 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : Bedford | 0 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : NJ HCS | 20 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : Bronx | 19 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : Providence | 7 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : White River Junction | 17 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : NY Harbor HCS | 16 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : Bedford | 0 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : NJ HCS | 6 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : Bronx | 4 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : Providence | 0 Participants |
| Arm 1 - VA Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : White River Junction | 1 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : Bedford | 1 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : NY Harbor HCS | 35 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : Bronx | 18 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : Bedford | 3 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : White River Junction | 5 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : NJ HCS | 20 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : Providence | 7 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : Bronx | 14 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : NJ HCS | 7 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : Providence | 8 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : White River Junction | 15 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Counselling - 6 months : White River Junction | 8 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : Providence | 1 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : NY Harbor HCS | 78 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : NY Harbor HCS | 18 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : Bedford | 3 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Bupropion - 6 months : Bronx | 6 Participants |
| Arm 2 - Quitline Counseling | VA Site-level Performance Rates on the VA Tobacco Performance Measures | NRT - 6 months : NJ HCS | 29 Participants |