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Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial.
BMC Public Health. 2014 Dec 17; 14:1294.BP

Abstract

BACKGROUND

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 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/DESIGN

We 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.

DISCUSSION

Mental 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 REGISTRATION

Clinicaltrials.gov: NCT01737281 (registered November 5, 2012).

Authors+Show Affiliations

VA New York Harbor Healthcare System, 423 East 23rd Street, New York, NY 10010, USA. erin.rogers2@va.gov.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25518878

Citation

Rogers, Erin S., et al. "Proactive Outreach for Smokers Using VHA Mental Health Clinics: Protocol for a Patient-randomized Clinical Trial." BMC Public Health, vol. 14, 2014, p. 1294.
Rogers ES, Fu SS, Krebs P, et al. Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial. BMC Public Health. 2014;14:1294.
Rogers, E. S., Fu, S. S., Krebs, P., Noorbaloochi, S., Nugent, S. M., Rao, R., Schlede, C., & Sherman, S. E. (2014). Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial. BMC Public Health, 14, 1294. https://doi.org/10.1186/1471-2458-14-1294
Rogers ES, et al. Proactive Outreach for Smokers Using VHA Mental Health Clinics: Protocol for a Patient-randomized Clinical Trial. BMC Public Health. 2014 Dec 17;14:1294. PubMed PMID: 25518878.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial. AU - Rogers,Erin S, AU - Fu,Steven S, AU - Krebs,Paul, AU - Noorbaloochi,Siamak, AU - Nugent,Sean M, AU - Rao,Radha, AU - Schlede,Carolyn, AU - Sherman,Scott E, Y1 - 2014/12/17/ PY - 2014/11/03/received PY - 2014/12/01/accepted PY - 2014/12/19/entrez PY - 2014/12/19/pubmed PY - 2015/9/16/medline SP - 1294 EP - 1294 JF - BMC public health JO - BMC Public Health VL - 14 N2 - BACKGROUND: 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 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/DESIGN: We 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. DISCUSSION: Mental 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 REGISTRATION: Clinicaltrials.gov: NCT01737281 (registered November 5, 2012). SN - 1471-2458 UR - https://www.unboundmedicine.com/medline/citation/25518878/Proactive_outreach_for_smokers_using_VHA_mental_health_clinics:_protocol_for_a_patient_randomized_clinical_trial_ L2 - https://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-14-1294 DB - PRIME DP - Unbound Medicine ER -