Faculty Bibliography

INTRODUCTION: People with a mental health diagnosis have high rates of tobacco use and encounter limited availability of tobacco treatment targeted to their needs. This study compared the effectiveness of a specialized telephone smoking-cessation intervention developed for mental health patients with standard state quit-line counseling. DESIGN: RCT. SETTING/PARTICIPANTS: The study was conducted at six Veterans Health Administration facilities in the Northeast U.S. Participants were 577 mental health clinic patients referred by their providers for smoking-cessation treatment. INTERVENTION: From 2010 to 2012, the study implemented a telephone program that included patient referral from a mental health provider, mailed cessation medications, and telephone counseling. Participants were randomized to receive a specialized multisession telephone counseling protocol (n=270) or transfer to their state's quit-line for counseling (n=307). MAIN OUTCOME MEASURES: Participants completed telephone surveys at baseline, 2 months, and 6 months. The study's primary outcome was self-reported 30-day abstinence at 6 months. Secondary outcomes were self-reported 30-day abstinence, counseling satisfaction and counseling content at 2 months, and self-reported use of cessation treatment and quit attempts at 6 months. Logistic regression was used to compare treatment groups on outcomes, controlling for baseline cigarettes per day and site. Inverse probability weighting and multiple imputation were used to handle missing abstinence outcomes. Data were analyzed in 2014-2015. RESULTS: At 6 months, participants in the specialized counseling arm were more likely to report 30-day abstinence (26% vs 18%, OR=1.62, 95% CI=1.24, 2.11). There was no significant group difference in abstinence at 2 months (18% vs 14%, OR=1.31, 95% CI=0.49, 3.49). Participants in the specialized arm were more likely to be assisted with developing a quit plan; receive follow-up calls after quitting; and receive counseling on several domains, including motivation, confidence, smoking triggers, coping with urges, and mental health symptoms (all p<0.05). Specialized counseling participants were more satisfied with treatment and more likely to find the counseling useful (p<0.05). CONCLUSIONS: The specialized counseling intervention was more effective at helping patients quit than transfer to a state quit-line. Patients were more satisfied with the specialized counseling program. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT00724308.

BACKGROUND: This paper describes fidelity monitoring (treatment differentiation, training, delivery, receipt and enactment) across the seven National Institutes of Health-supported Consortium of Hospitals Advancing Research on Tobacco (CHART) studies. The objectives of the study were to describe approaches to monitoring fidelity including treatment differentiation (lack of crossover), provider training, provider delivery of treatment, patient receipt of treatment, and patient enactment (behavior) and provide examples of application of these principles. METHODS: Conducted between 2010 and 2014 and collectively enrolling over 9500 inpatient cigarette smokers, the CHART studies tested different smoking cessation interventions (counseling, medications, and follow-up calls) shown to be efficacious in Cochrane Collaborative Reviews. The CHART studies compared their unique treatment arm(s) to usual care, used common core measures at baseline and 6-month follow-up, but varied in their approaches to monitoring the fidelity with which the interventions were implemented. RESULTS: Treatment differentiation strategies included the use of a quasi-experimental design and monitoring of both the intervention and control group. Almost all of the studies had extensive training for personnel and used a checklist to monitor the intervention components, but the items on these checklists varied widely and were based on unique aspects of the interventions, US Public Health Service and Joint Commission smoking cessation standards, or counselor rapport. Delivery of medications ranged from 31 to 100 % across the studies, with higher levels from studies that gave away free medications and lower levels from studies that sought to obtain prescriptions for the patient in real world systems. Treatment delivery was highest among those studies that used automated (interactive voice response and website) systems, but this did not automatically translate into treatment receipt and enactment. Some studies measured treatment enactment in two ways (e.g., counselor or automated system report versus patient report) showing concurrence or discordance between the two measures. CONCLUSION: While fidelity monitoring can be challenging especially in dissemination trials, the seven CHART studies used a variety of methods to enhance fidelity with consideration for feasibility and sustainability. TRIAL REGISTRATION: Dissemination of Tobacco Tactics for hospitalized smokers. Clinical Trials Registration No. NCT01309217.Smoking cessation in hospitalized smokers. Clinical Trials Registration No. NCT01289275.Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial. Clinical Trials Registration No. NCT01305928.Web-based smoking cessation intervention that transitions from inpatient to outpatient. Clinical Trials Registration No. NCT01277250.Effectiveness of smoking-cessation interventions for urban hospital patients. Clinical Trials Registration No. NCT01363245.Comparative effectiveness of post-discharge interventions for hospitalized smokers. Clinical Trials Registration No. NCT01177176.Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals. Clinical Trials Registration No. NCT01236079.

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).

BACKGROUND: Standardized Patients (SPs) are actors trained to portray health care patients during the training and assessment of health care providers. This paper describes the methods and costs associated with using SPs to evaluate the skills of telephone counselors working on a clinical trial that evaluated a telephone smoking cessation program tailored for smokers using Department of Veterans Affairs mental health clinics. FINDINGS: Conducting the SP exercises required five main steps: (1) Write a SP case description detailing patient demographics, demeanor, clinical symptoms and history, and instructions on how to respond to counseling, (2) Identify, select and train actors to portray the SP cases; (3) Conduct audio-taped counseling encounters between the SPs and counselors, (4) Rate the counselors on their core counseling competencies, (5) Provide feedback to counselors. The SPs and study supervisors reported that the checklist was easy to use when rating the counselors. Counselors reported that the SP encounters were realistic and helpful for practicing their clinical work and for building self-efficacy for working with real patients. The labor costs of developing two SP cases and training two SP actors was approximately $1,475. The per-session labor cost of conducting a 1-hour counseling session between one SP and one counselor was approximately $314. CONCLUSIONS: Using SPs to train telephone counselors working on a clinical trial was feasible and offered training benefits beyond those provided by didactic instruction and role plays. Our research group is now routinely using SPs for the training of incoming telephone counselors.

OBJECTIVES: We examined tobacco use screening and treatment by US psychiatrists before and after release of the 1996 American Psychiatric Association (APA) nicotine dependence treatment guidelines. METHODS: We used data from the National Ambulatory Medical Care Survey to identify rates of tobacco screening and treatment by psychiatrists before the release of the guidelines (1993-1996) and during 2 postguidelines periods: 2001-2005 and 2006-2010. Multiple logistic regression was used to compare preguidelines and postguidelines rates. RESULTS: Psychiatrists screened for tobacco use during 77% of visits from 1993 to 1996, 69% of visits from 2001 to 2005 (odds ratio [OR] = 0.69; 95% confidence interval [CI] = 0.64, 0.75), and 60% of visits from 2006 to 2010 (OR = 0.46; 95% CI = 0.43, 0.50). Psychiatrists provided cessation counseling to 12% of smokers from 1993 to 1996, 11% from 2001 to 2005 (OR = 0.97; 95% CI = 0.74, 1.26), and 23% from 2006 to 2010 (OR = 2.23; 95% CI = 1.74, 2.86). Psychiatrists prescribed nicotine replacement therapy to fewer than 1% of smokers during all 3 time periods. CONCLUSIONS: Psychiatrists are screening for tobacco use at declining rates, and the proportion of smokers provided with treatment remains low.