Faculty Bibliography

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.

OBJECTIVE: It is unclear whether training physicians to counsel obese patients leads to weight loss. This study assessed whether a 5-h multimodal longitudinal obesity curriculum for residents on the basis of the 5As (assess, advise, agree, assist, and arrange) was associated with weight loss in their obese patients. DESIGN AND METHODS: Twenty-three primary care internal medicine residents were assigned by rotation schedule to intervention (curriculum) or control groups. We then conducted follow-up chart reviews to determine weight change at up to 12 months following the index visit. 158 obese patients (76 in the intervention group and 82 in the control group) completed exit interviews; 22 patients who presented for acute care at the index visit were excluded. Chart reviews were conducted on the 46 patients in the intervention group and 41 patients in the control group who were seen again within 12 months of the index visit and had follow-up weight measurements. RESULTS: The main outcome of interest was mean change in weight at 12 months compared between the intervention and control groups. Patients of residents in the intervention group had a mean weight loss of -1.53 kg (s.d. = 3.72) although the patients of those in the control group had a mean weight gain of 0.30 kg (s.d. = 3.60), P = 0.03. Six (15.8%) patients in the intervention group and 2 (5.4%) patients in the control group lost >5% body weight (P = 0.14). CONCLUSIONS: Although the magnitude of weight loss was small, this study shows that training physicians to counsel patients can produce measurable patient outcomes.

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.