Faculty Bibliography

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.

BACKGROUND: This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines. METHODS/DESIGN: The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state's quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data (e.g., self-reported abstinence at six months) and both quantitative and qualitative implementation data (e.g., provider referral rates, coded interviews with providers). Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. DISCUSSION: This paper describes the rationale and methods of a trial designed to simultaneously study the clinical effectiveness and implementation of a telephone smoking cessation program for smokers using VA mental health clinics. Such hybrid designs are an important methodological design that can shorten the time between the development of an intervention and its translation into routine clinical care. TRIAL REGISTRATION: ClinicalTrials.gov NCT00724308.

ABSTRACT: BACKGROUND: Hospitalization may be a particularly important time to promote smoking cessation, especially in the immediate post-discharge period. However, there are few studies to date that shed light on the most effective or cost-effective methods to provide post-discharge cessation treatment, especially among low-income populations and those with a heavy burden of mental illness and substance use disorders. METHODS/DESIGN: This randomized trial will compare the effectiveness and cost-effectiveness of two approaches to smoking cessation treatment among patients discharged from two urban public hospitals in New York City. During hospitalization, staff will be prompted to ask about smoking and to offer nicotine replacement therapy (NRT) on admission and at discharge. Subjects will be randomized on discharge to one of two arms: one arm will be proactive multi-session telephone counseling with motivational enhancement delivered by study staff, and the other will be a faxed or online referral to the New York State Quitline. The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost-effectiveness from a societal and a payer perspective, as well as explore subgroup analyses related to patient location of hospitalization, race/ethnicity, immigrant status, and inpatient diagnosis. DISCUSSION: This study will explore issues of implementation feasibility in a post-hospitalization patient population, as well as add information about the effectiveness and cost-effectiveness of different strategies for designing smoking cessation programs for hospitalized patients. TRIAL REGISTRATION: Clinicaltrials.gov ID# NCT01363245.

BACKGROUND: Proactive telephone-based smoking cessation counseling is an emerging approach to helping mental health patients quit smoking, and it is unclear whether all patients benefit equally. We examined whether mental health patients enrolled in a telephone smoking cessation program with higher Global Assessment of Functioning (GAF) scores had better quit rates at 6 month follow-up compared to mental health patients with lower GAF scores. METHODS: We analyzed preliminary data from a multi-site VA study implementing a telephone care coordination program for smokers with mental illness. VA providers referred smoking patients to the program via a CPRS consult, and 366 referred patients enrolled in the program. We randomized participants to receive counseling from either a state Quitline or a VA counselor. We collected patient GAF scores through the CPRS system for those enrolled in counseling using the most recent GAF score received prior to their program enrollment date. Based upon the GAF's definition of functionality and of what constituted serious impairment of functioning, we categorized GAF scores above 50 as "high functioning" and scores 50 and below as "low functioning." Patients completed a phone survey at 6 months that assessed their 30-day point prevalence abstinence. RESULTS: GAF scores were available for 103/180 patients who had enrolled in counseling and completed the 6 month follow-up. Of those patients, 70 (68%) had high GAF scores and 33 (32%) had low GAF scores. At 6-month follow-up, 33/103 (32%) had quit smoking. There was no difference in abstinence rates between the high and low functioning GAF groups (33% versus 30%, OR=1.13, 95%CI=0.46-2.75). The GAF score was completed on average 125 days before the smoking cessation referral, and there was no significant difference in the interval between the high GAF and low GAF groups (99 vs. 181 days; p>.05). CONCLUSIONS: The telephone smoking cessation program produced excellent long-term abstinence rates and was equally effective !