Telephone Care Coordination for Smokers in VA Mental Health Clinics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Telephone Care Coordination for Smokers in Mental Health Clinics

Conditions
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Smoking

Intervention / Treatment
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* Other: Telephone Care Coordination
* Other: Telephone Care Coordination with state Quitline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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. | Other: Telephone Care Coordination<br>* 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.<br>|
| Experimental: Arm 2<br>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. | Other: Telephone Care Coordination with state Quitline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) |  | 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 2 and 6 months after enrollment | 
| VA Site-level Performance Rates on the VA Tobacco Performance Measures |  | Quarterly after study implementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Smoking Cessation, Tobacco, Mental Health