Abstract
BackgroundPersons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence, low rates of tobacco treatment referrals from mental health providers, and limited availability of tobacco treatment targeted to their needs. This manuscript describes the rationale and methods of a clinical trial with the following aims: 1) Compare the reach and efficacy of a proactive telephone-based tobacco cessation program for Veterans Health Administration (VHA) mental health clinic patients to VHA usual care and 2) Model longitudinal associations between baseline patient characteristics and long-term abstinence.Methods/designWe will use the electronic medical record to identify patients across four VHA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past six months and who have had a mental health clinic visit in the past 12 months. We will send each patient an introductory letter and baseline survey. Survey respondents (N = 3840) will be randomized in a 1:1 fashion to intervention or control. Control participants will receive VHA usual care. Intervention participants will receive proactive motivational telephone outreach to offer tobacco treatment. Intervention participants interested in treatment will receive eight weeks of nicotine replacement therapy plus eight sessions of specialized telephone counseling over two months, followed by monthly maintenance counseling for four months. We will conduct telephone surveys with participants at six and 12 months to assess study outcomes. We will collect a mailed saliva sample from patients reporting 7-day abstinence on the telephone surveys. The primary outcome will be cotinine-validated abstinence at 12-month follow-up.DiscussionMental health patients are a high-risk smoking population with significant barriers to cessation. This study will evaluate the efficacy of a program that proactively reaches out to smokers with a mental health treatment history to engage them into telephone cessation counseling targeted to the needs of mental health patients.Trial registrationClinicaltrials.gov: NCT01737281 (registered November 5, 2012).
Highlights
Persons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence, low rates of tobacco treatment referrals from mental health providers, and limited availability of tobacco treatment targeted to their needs
This study will evaluate the efficacy of a program that proactively reaches out to smokers with a mental health treatment history to engage them into telephone cessation counseling targeted to the needs of mental health patients
To overcome access barriers and to better meet the needs of tobacco-dependent mental health patients, we have designed and initiated a patient-randomized controlled trial that adapts a program that was previously found to be effective at increasing access to tobacco treatment and population-level abstinence among smokers using Veterans Health Administration (VHA) primary care clinics [21]
Summary
Persons with a mental health diagnosis use tobacco at alarming rates, which has a large negative impact on their health and quality of life. Their increased vulnerabilities to tobacco dependence, high risk for relapse, and difficulties in accessing tobacco treatment make them an important population to target with tobacco cessation interventions. Authors’ contributions SES and SSF are Co-Principal Investigators on the entire study. SES, SSF, ESR, and PK developed the study protocol and obtained funding. All authors contributed to the preparation of the manuscript. All authors read and approved the final manuscript
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