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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. |
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| Arm 2 | Experimental | 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 smoking cessation "Quitline"; and (4) follow-up at 2 and 6 months to check the patient's smoking status. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Care Coordination | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) | 6 months after enrollment |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott E Sherman, MD MPH | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497630 | Result | Rogers E, Fernandez S, Gillespie C, Smelson D, Hagedorn HJ, Elbel B, Kalman D, Axtmayer A, Kurowski K, Sherman SE. Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial. Addict Sci Clin Pract. 2013 Mar 15;8(1):7. doi: 10.1186/1940-0640-8-7. | |
| 24903609 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) | Posted | Number | participants | 6 months after enrollment |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Sherman | VA NY Harbor Healthcare System | 212-686-7500 | 7386 | scott.sherman@va.gov |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D010549 | Personal Satisfaction |
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| Telephone Care Coordination with state Quitline | Other | 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. |
|
| 2 and 6 months after enrollment |
| VA Site-level Performance Rates on the VA Tobacco Performance Measures | Quarterly after study implementation |
| Rogers ES, Gillespie C, Zabar S, Sherman SE. Using standardized patients to train telephone counselors for a clinical trial. BMC Res Notes. 2014 Jun 5;7:341. doi: 10.1186/1756-0500-7-341. |
| 37936218 | Derived | Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The effectiveness of a telephone smoking cessation program in mental health clinic patients by level of mental well-being and functioning: a secondary data analysis of a randomized clinical trial. BMC Public Health. 2023 Nov 7;23(1):2190. doi: 10.1186/s12889-023-16975-z. |
| 37674733 | Derived | Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The Effectiveness of a Telephone Smoking Cessation Program in Mental Health Clinic Patients by Level of Mental Well-Being and Functioning: A Secondary Data Analysis of a Randomized Clinical Trial. Res Sq [Preprint]. 2023 Aug 24:rs.3.rs-3179446. doi: 10.21203/rs.3.rs-3179446/v1. |
| 26711163 | Derived | Rogers ES, Smelson DA, Gillespie CC, Elbel B, Poole S, Hagedorn HJ, Kalman D, Krebs P, Fang Y, Wang B, Sherman SE. Telephone Smoking-Cessation Counseling for Smokers in Mental Health Clinics: A Patient-Randomized Controlled Trial. Am J Prev Med. 2016 Apr;50(4):518-527. doi: 10.1016/j.amepre.2015.10.004. Epub 2015 Dec 17. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment) | Posted | Count of Participants | Participants | 2 months after enrollment |
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| Secondary | Quit Attempt Rate | Posted | Count of Participants | Participants | 2 and 6 months after enrollment |
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| Secondary | Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) | Posted | Count of Participants | Participants | 2 and 6 months after enrollment |
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| Secondary | VA Site-level Performance Rates on the VA Tobacco Performance Measures | Participants could receive more than one type of treatment, therefore counts do not necessarily sum to the total number of participants. | Posted | Count of Participants | Participants | Quarterly after study implementation |
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| 0 |
| 270 |
| 0 |
| 270 |
| EG001 | Arm 2 | 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. | 0 | 307 | 0 | 307 |
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| Counselling - 6 months : Bedford |
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| Counselling - 6 months : NJ HCS |
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| Counselling - 6 months : Bronx |
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| Counselling - 6 months : Providence |
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| Counselling - 6 months : White River Junction |
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| NRT - 6 months : NY Harbor HCS |
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| NRT - 6 months : Bedford |
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| NRT - 6 months : NJ HCS |
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| NRT - 6 months : Bronx |
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| NRT - 6 months : Providence |
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| NRT - 6 months : White River Junction |
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| Bupropion - 6 months : NY Harbor HCS |
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| Bupropion - 6 months : Bedford |
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| Bupropion - 6 months : NJ HCS |
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| Bupropion - 6 months : Bronx |
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| Bupropion - 6 months : Providence |
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| Bupropion - 6 months : White River Junction |
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