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.

This study examines the validity of a Spanish-language dietary behaviors self-report questionnaire (The Latino Dietary Behaviors Questionnaire [LDBQ]) for Latinos with diabetes. The sample (n=252) was Spanish-speaking, female (77%), middle-aged (mean age 55 years), low education (56% <8th grade>education), and low income (50% <$10,000 annual household income). Baseline and 12-month measures were collected as part of a randomized clinical trial. LDBQ reliability, validity, and sensitivity to change over time were evaluated using exploratory factor analysis; internal consistency analysis; and correlation analysis using baseline and change scores for LDBQ, 3-day 24-hour dietary recall nutrient mean, and clinical measures. Cronbach's alphas were moderate. Four factors were identified at both time points. Significant baseline correlations (r) were found for LDBQ total scores; factor scores; and energy intake (r=-0.29 to -0.34), total dietary fiber (r=0.19), sodium (r=-0.24 to -0.30), percent energy from total fat (r=-0.16), fat subtypes (r=-0.16 to 0.15), and percent energy from protein (r=0.17). Twelve-month data produced a similar pattern. T tests of LDBQ change scores showed significantly greater change in dietary behaviors for the intervention group than for the control group, t(135)=-4.17, P<0.01. LDBQ change scores correlated significantly with mean 24-hour nutrient intake and a subset of clinical measures, but were not associated with clinical change scores (except high-density lipoprotein cholesterol). The LDBQ is a useful tool to assess and target behaviors for change and assess intervention effects. Inc. All rights reserved.