Costs to provide a tobacco cessation intervention with parents of pediatric emergency department patients.

INTRODUCTION: Pediatric emergency department (PED) visits are opportune times in which to provide smoking cessation interventions for parents who smoke. This study reports on the costs of providing parental smokers who bring their children to the emergency setting, with a screening, brief intervention, and assisted referral to treatment (SBIRT) intervention, which includes counseling about tobacco cessation and nicotine replacement therapy. METHODS: Cost data were collected during a randomized controlled trial with 750 parental smokers whose child was presented to a PED or pediatric Urgent Care unit with a potential tobacco smoke exposure-related illness. Interventionist training, screening, and SBIRT costs are reported from the organizational perspective (i.e. that of the providing hospital). A spreadsheet tool was created to allow for organizations to estimate their own costs based on their settings, for each aspect of the intervention. RESULTS: The mean costs per parent included interventionist training, screening and enrollment, SBIRT delivery, distribution of take-home materials and nicotine replacement therapy, booster text messages, and follow-up phone contact. The total cost per parent was approximately $97. Varying the underlying cost assumptions led to total costs ranging from $85 to $124 per treated parent. CONCLUSIONS: The emergency setting is an important locus of tobacco control that could have a large public health benefit to parents and children. The costs reported in this report and the accompanying spreadsheet tool will permit emergency settings to estimate the costs and assist with planning, staffing and resource allocation necessary to implement an SBIRT smoking cessation intervention in research-based and clinically-based cessation interventions into adult or pediatric emergency visits.

Effect of a Responsiveness-Based Support Intervention on Smokeless Tobacco Cessation: The UCare-ChewFree Randomized Clinical Trial.

INTRODUCTION: Partner behaviors and attitudes can motivate or undermine a tobacco user's cessation efforts. We developed a multimedia intervention, UCare (Understanding-CAring-REspect) for women who wanted their male partner to quit smokeless tobacco (ST), based on perceived partner responsiveness-the empirically based theory that support is best received when the supporter conveys respect, understanding, and caring. METHODS: One thousand one hundred three women were randomized to receive either immediate access to the UCare website and printed booklet (Intervention; N = 552), or a Delayed Treatment control (N = 551). We assessed supportive behaviors and attitudes at baseline and 6-week follow-up, and the ST-using partner's abstinence at 6 weeks and 7.5 months (surrogate report). RESULTS: For partners of women assigned to Intervention, 7.0% had quit all tobacco at 7.5 months, compared with 6.6% for control (χ2 (1, n = 1088) = .058, p = .810). For partners of women completing the intervention, 12.4% had quit all tobacco at 7.5 months, compared with 6.6% for Delayed Treatment (χ2 (1, n = 753) = 6.775, p = .009). A previously reported change in responsiveness-based behaviors and instrumental behaviors at 6 weeks mediated 7.5-month cessation, and change in responsiveness-based attitudes mediated the change in responsiveness-based behaviors, indirectly increasing cessation. CONCLUSIONS: A responsiveness-based intervention with female partners of male ST users improved supportive attitudes and behaviors, leading to higher cessation rates among tobacco users not actively seeking to quit. The study demonstrates the potential for responsiveness as a basis for effective intervention with supporters. This approach may reach tobacco users who would not directly seek help. IMPLICATIONS: This study demonstrates the value of a responsiveness-based intervention (showing respect, understanding, and caring) in training partners to provide support for a loved one to quit ST. In a randomized clinical trial, 1,103 women married to or living with a ST user were randomized to receive the UCare-ChewFree intervention (website + booklet) or a Delayed Treatment control. Women completing the intervention were more likely to improve their behaviors and attitudes, and change in behaviors and attitudes mediated cessation outcomes for their partners, who had not enrolled in the study and may not have been seeking to quit. TRIAL REGISTRATION: ClinicalTrials.gov NCT01885221.

A Multimedia Support Skills Intervention for Female Partners of Male Smokeless Tobacco Users: Use and Perceived Acceptability.

Background: UCare is a new multimedia (website+booklet) intervention for women who want their male partner to quit their use of smokeless tobacco. The intervention is based on research showing that perceived partner responsiveness to social support is highest when the supporter conveys respect, understanding, and caring in their actions. The website included both didactic and interactive features, with optional video components, and special activities to help women develop empathy for nicotine addiction. The booklet reinforced the website content, encouraged women to use the website, and served both as a physical reminder of the intervention and a convenient way to share the information with her partner. Objective: The objective of this study was to describe the utilization and acceptability of a multimedia intervention among women seeking to support their partner in quitting smokeless tobacco. Lessons learned with respect to design considerations for online interventions are also summarized. Methods: We present the evaluation of the intervention components' use and usefulness in a randomized trial. Results: In the randomized clinical trial, more than 250,000 visits were made to the website in a 2-year period, with the vast majority from mobile devices. Of the 552 women randomized to receive the intervention, 96.9% (535/552) visited the website at least once, and 30.8% (170/552) completed the core website component, "The Basics." About half of the women (287/552) used the interactive "Take Notes" feature, and 37% (204/552) used the checklists. Few women used the post-Basics features. At 6 weeks, 40.7% (116/285) reported reading the printed and mailed booklet. Website and booklet use were uncorrelated. User ratings for the website and booklet were positive overall. Conclusions: Intervention website designers should consider that many users will access the program only once or twice, and many will not complete it. It is also important to distinguish between core and supplemental features and to consider whether the primary purpose is training or support. Furthermore, printed materials still have value. Trial Registration: ClinicalTrials.gov NCT01885221; https://clinicaltrials.gov/ct2/show/NCT01885221 (Archived by WebCite at http://www.webcitation.org/6zdIgGGtx).

Using Facebook for Large-Scale Online Randomized Clinical Trial Recruitment: Effective Advertising Strategies.

Targeted Facebook advertising can be an effective strategy to recruit participants for a large-scale online study. Facebook advertising is useful for reaching people in a wide geographic area, matching a specific demographic profile. It can also target people who would be unlikely to search for the information and would thus not be accessible via Google AdWords. It is especially useful when it is desirable not to raise awareness of the study in a demographic group that would be ineligible for the study. This paper describes the use of Facebook advertising to recruit and enroll 1145 women over a 15-month period for a randomized clinical trial to teach support skills to female partners of male smokeless tobacco users. This tutorial shares our study team's experiences, lessons learned, and recommendations to help researchers design Facebook advertising campaigns. Topics covered include designing the study infrastructure to optimize recruitment and enrollment tracking, creating a Facebook presence via a fan page, designing ads that attract potential participants while meeting Facebook's strict requirements, and planning and managing an advertising campaign that accommodates the rapid rate of diminishing returns for each ad.

Healthy families: study protocol for a randomized controlled trial of a screening, brief intervention, and referral to treatment intervention for caregivers to reduce secondhand smoke exposure among pediatric emergency patients.

BACKGROUND: Involuntary exposure to secondhand smoke (SHSe) is an important cause of morbidity in children who present to the pediatric emergency department (PED) and urgent care (UC). SHSe interventions delivered in the PED and UC would benefit both the smoker and child, but there have been no large trials testing the efficacy of such interventions. The Healthy Families program is the first randomized controlled trial to test whether a screening, brief intervention, and referral to treatment (SBIRT) intervention delivered in the PED and UC will be effective in decreasing SHSe in children and increasing cessation in smokers. METHODS/DESIGN: This trial uses a randomized, two-group design in which caregiver-smokers of children 0-17 years old are recruited from the PED and UC. Eligible caregiver-smokers are randomized to either the: 1) SBIRT Condition with face-to-face, tailored counseling that focuses on the child's illness, the importance of reducing child SHSe, caregiver smoking cessation, and the option to receive nicotine replacement therapy; or 2) Healthy Habits Control Condition which includes face-to-face, tailored attention control "5-2-1-0" counseling that focuses on improving the child's health. Dyadic assessments are conducted in-person at baseline, and via email, phone, or in-person at 6-weeks and 6-months. The primary outcomes are biochemically-verified, 7-day point prevalence and prolonged smoking abstinence. Secondary outcomes are cigarettes smoked per week, 24 h quit attempts, and biochemically validated child SHSe at each time point. The costs of this intervention will also be analyzed. DISCUSSION: This study will test an innovative, multilevel intervention designed to reduce child SHSe and increase smoking cessation in caregivers. If effective and routinely used, this SBIRT model could reach at least one million smokers a year in the U.S., resulting in significant reductions in caregivers' tobacco use, SHSe-related pediatric illness, and healthcare costs in this population of children. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02531594. Date of registration: August 4, 2015.

Utility of Responsiveness Theory for Classifying Supportive Behaviors to Enhance Smokeless Tobacco Cessation.

INTRODUCTION: Although social support is correlated with successful tobacco cessation, interventions designed to optimize social support have shown mixed results. Understanding the process of providing social support for tobacco cessation may suggest new approaches to intervention. Responsiveness theory provides a new framework for classifying supportive behaviors in the context of tobacco cessation. It proposes three main components to sustaining relationship quality when providing support to an intimate partner: showing respect, showing understanding, and showing caring. METHODS: Interviews were conducted with 35 women whose husbands or domestic partners had quit smokeless tobacco and were analyzed within a responsiveness theory framework: Positive and negative instances of the three supportive components were expressed in terms of beliefs and attitudes, interactions with the chewer, and behaviors outside of the interaction context. RESULTS: Positive activities included respecting the chewer's decision on whether, when, and how to quit; perspective-taking and other efforts to understand his subjective experience; and expressing warmth and affection toward the chewer. Particularly problematic for the women were the challenges of respecting the chewer's autonomy (ie, negative behaviors such as nagging him to quit or monitoring his adherence to his cessation goal) and lack of understanding the nature of addiction. CONCLUSIONS: The findings help to confirm the potential utility of responsiveness theory for elucidating the breadth of both positive and negative forms of partner support that may be useful to guide social support interventions for tobacco cessation. IMPLICATIONS: The study provides a categorization system for positive and negative social support during smokeless tobacco cessation, based on responsiveness theory and interviews with 35 partners of smokeless users.

Randomized trial of nicotine lozenges and phone counseling for smokeless tobacco cessation.

INTRODUCTION: Relatively few treatment programs have been developed specifically for smokeless tobacco (ST) users who want to quit. Their results suggest that self-help materials, telephone counseling, and nicotine lozenges are efficacious. This study provides the first direct examination of the separate and combined effects of telephone counseling and lozenges. METHODS: We recruited ST users online (N = 1067) and randomly assigned them to 1 of 3 conditions: (a) a lozenge group (n = 356), who were mailed 4-mg nicotine lozenges; (b) a coach calls group (n = 354), who were offered 3 coaching phone calls; or (c) a lozenge + coach calls group (N = 357), who received both lozenges and coaching calls. Additionally, all participants were mailed self-help materials. Self-reported tobacco abstinence was assessed at 3 and 6 months after randomization. RESULTS: Complete-case and intention-to-treat (ITT) analyses for all tobacco abstinence were performed at 3 months, 6 months, and both 3 and 6 months (repeated point prevalence). ITT analyses revealed a highly similar result: the lozenge + coach calls condition was significantly more successful in encouraging tobacco abstinence than either the lozenge group or the coach calls group, which did not differ. CONCLUSIONS: Combining nicotine lozenges and phone counseling significantly increased tobacco abstinence rates compared with either intervention alone, whereas coach calls and lozenges were equivalent. The study confirms the high tobacco abstinence rates for self-help ST cessation interventions and offers guidance to providing tobacco treatment to ST users.

Women helping chewers: Effects of partner support on 12-month tobacco abstinence in a smokeless tobacco cessation trial.

INTRODUCTION: Social support has been relatively unstudied in smokeless tobacco cessation research; partner support could encourage quitting, buffer the stress of quitting and withdrawal, and counteract tobacco cues. METHODS: Using 12-month follow-up data, we examined the impact of social support provided by female partners (n = 328) of male participants in a smokeless tobacco cessation program. RESULTS: The ratio of positive support to negative support that participants reported receiving from their partners was significantly related to point prevalence 12-month tobacco abstinence (odds ratio [OR] = 1.43, 95% CI = 1.11-1.84, p < .01)-a finding consistent with the 6-month follow-up-and it was related to repeated point prevalence tobacco abstinence at both 6 and 12 months (OR = 1.43, 95% CI = 1.09-1.88, p < .05). DISCUSSION: These 12-month follow-up results provide additional evidence that partner support can help encourage long-term tobacco abstinence among participants in smokeless tobacco cessation programs.

ChewFree.com: evaluation of a Web-based cessation program for smokeless tobacco users.

The sizeable percentage of adults who use smokeless tobacco (ST) represents an important public health target since the majority of ST users have a strong desire to quit, but many lack resources. We tested the impact of an interactive, tailored Web-based intervention (Enhanced Condition) versus a more linear, text-based website (Basic Condition) in a randomized trial with 2523 adult ST users. As is common in Internet-based research, there was considerable attrition: follow-up rates at 3 months, 6 months, and for both 3 and 6 months were 48%, 45% and 34%, respectively. Results using repeated point prevalence of all tobacco use at 3 and 6 months showed that participants in the Enhanced Condition quit at significantly higher rates than those in the Basic Condition. Using a Complete Case analysis, abstinence was 40.6% in the Enhanced Condition vs. 21.2% in the Basic Condition (p< .001). Using intent-to-treat analysis, quit rates were 12.6% vs. 7.9%, respectively (p< .001). Similar results were obtained for only ST use. Unobtrusive measures of program exposure indicated that program use was significantly related to outcome as well as to attrition. We conclude that a tailored, interactive Web-assisted cessation program can be an efficacious method for assisting adult ST users to quit.

Cost-effectiveness of self-help smokeless tobacco cessation programs.

This study assessed the cost-effectiveness of two low-intensity programs for quitting smokeless tobacco, based on results of a randomized trial with 1,069 volunteer participants. Cost data were collected for two levels of intervention: manual only (a self-help manual) and assisted self-help (the manual plus a videotape and two supportive phone calls from tobacco cessation counselors). Incremental cost-effectiveness ratios were calculated for assisted self-help vs. quitting on one's own, using the manual-only quit rate and data from another study as alternative proxies for no intervention. A threshold analysis was conducted to determine the spontaneous quit rate at which the manual-only intervention becomes more cost-effective than assisted self-help. The cost to provide and receive the assisted self-help intervention averaged US $56 per participant vs. $20 for the manual-only intervention (societal perspective, Year 2000 dollars). Estimates for incremental cost per quit for the assisted self-help intervention ranged from $922 to $1,758, depending on the proxy used for no intervention. The manual-only intervention was more cost-effective than assisted self-help if quitting among motivated chewers who do not receive treatment does not exceed 3.4%. Support from a wife or partner added little cost to a quit attempt for male chewers ($3-$4). Providing a manual, video, and brief phone counseling to smokeless tobacco users who want to quit is a reasonable use of health care resources. The self-help quitting guide also may be a cost-effective treatment, but it remains to be demonstrated whether it is more effective than quitting on one's own.

Self-help cessation programs for smokeless tobacco users: long-term follow-up of a randomized trial.

This paper presents long-term outcomes of the largest clinical trial of smokeless tobacco (SLT) cessation reported to date. SLT users in five northwestern states were recruited to call a toll-free number, and 1,069 users were randomized to one of two self-help conditions: either a manual-only condition or an assisted self-help condition, which included the manual, a targeted video, and two support phone calls. Significant between-group differences were not found for either the 12- or 18-month point-prevalence measure of abstinence from either SLT only or all tobacco products using outcomes based on either the responder or intention-to-treat outcomes. However, using a repeated point-prevalence measure across all three assessment points, we found that significantly more assisted self-help participants reported abstinence, compared with manual-only participants. Compared with manual-only participants, those in the assisted self-help condition were significantly more likely to use recommended cessation techniques. Results demonstrate that low-cost, minimal interventions delivered by mail and phone can help a sizable proportion of individuals quit using SLT.

Defining participant exposure measures in Web-based health behavior change programs.

BACKGROUND: Published research on the use of Web-based behavior change programs is growing rapidly. One of the observations characterized as problematic in these studies is that participants often make relatively few website visits and spend only a brief time accessing the program. Properly structured websites permit the unobtrusive measurement of the ways in which participants access (are exposed to) program content. Research on participant exposure to Web-based programs is not merely of interest to technologists, but represents an important opportunity to better understand the broader theme of program engagement and to guide the development of more effective interventions. OBJECTIVES: The current paper seeks to provide working definitions and describe initial patterns of various measures of participant exposure to ChewFree.com, a large randomized controlled trial of a Web-based program for smokeless tobacco cessation. METHODS: We examined measures of participant exposure to either an Enhanced condition Web-based program (interactive, tailored, and rich-media program) or a Basic condition control website (static, text-based material). Specific measures focused on email prompting, participant visits (number, duration, and pattern of use over time), and Web page viewing (number of views, types of pages viewed, and Web forum postings). RESULTS: Participants in the ChewFree.com Enhanced condition made more visits and spent more time accessing their assigned website than did participants assigned to the Basic condition website. In addition, exposure data demonstrated that Basic condition users thoroughly accessed program content, indicating that the condition provided a meaningful, face-valid control to the Enhanced condition. CONCLUSIONS: We recommend that researchers conducting evaluations of Web-based interventions consider the collection and analysis of exposure measures in the broader context of program engagement in order to assess whether participants obtain sufficient exposure to relevant program content.

Cost effectiveness of changing health professionals' behavior: training dental hygienists in brief interventions for smokeless tobacco cessation.

OBJECTIVE: Disseminating effective interventions to health care professionals is a critical step in ensuring that patients receive needed advice and materials. This cost effectiveness analysis compared two methods of disseminating an effective protocol for smokeless tobacco cessation intervention. METHOD: Interested dental hygienists (N = 1051) were recruited in 20 Western and Midwestern U.S. communities and randomized by community to receive workshop training, self-study with mailed materials, and delayed self-study training, in 1996-98. Hygienists were surveyed about their smokeless tobacco-related activities with patients at baseline and post-intervention. Data on intervention costs were collected, and incremental costs per unit of behavior change were calculated. RESULTS: Self-study was more cost effective than workshop training under a wide range of assumptions: change in group versus individual behavior, hygienists' time and travel costs included or excluded, and hygienist wage rates at the national median or substantially lower. However, workshops may be as cost effective in producing behavior change among hygienists earning wages substantially higher than the national median. CONCLUSION: Self-study may be a more cost effective method than workshops to achieve behavior change among motivated health professionals.

Successful participant recruitment strategies for an online smokeless tobacco cessation program.

An estimated 22% of Americans currently use smokeless tobacco (ST). Most live in small towns and rural areas that offer few ST cessation resources. Approximately 94 million Americans use the Internet for health-related information, and on-line access is growing among lower-income and less-educated groups. As part of a randomized clinical trial to assess the reach and effectiveness of Web-based programs for delivering an ST cessation intervention, the authors developed and evaluated several methods for overcoming the recruitment challenges associated with Web-based research. This report describes and evaluates these methods. Participants were recruited through: (a) Thematic promotional "releases" to print and broadcast media, (b) Google ads, (c) placement of a link on other Web sites, (d) limited purchase of paid advertising, (e) direct mailings to ST users, and (f) targeted mailings to health care and tobacco control professionals. Combined recruitment activities resulted in more than 23,500 hits on our recruitment website from distinct IP addresses over 15 months, which yielded 2,523 eligible ST users who completed the registration process and enrolled in the study. Self-reports revealed that at least 1,276 (50.6%) of these participants were recruited via mailings, 874 (34.6%) from Google ads or via search engines or links on another Web site, and 373 (14.8%) from all other methods combined. The use of thematic mailings is novel in research settings. Recruitment of study participants went quickly and smoothly. Google ads and mailings to media outlets were the methods that recruited the highest number of participants.

Disseminating a smokeless tobacco cessation intervention model to dental hygienists: a randomized comparison of personalized instruction and self-study methods.

This study evaluated 2 methods of disseminating an empirically validated smokeless tobacco intervention delivered during routine dental care. Twenty cities within 12 states were stratified and then randomized to 1 of 3 groups: personalized instruction (PI), self-study (SS), or delayed training (DT) control. Dental hygienists in the SS condition were sent a manual and video. Those in the PI condition were recruited to attend a workshop. Thirty-seven percent of eligible hygienists agreed to participate. At 12 months postenrollment, hygienists in the SS and PI conditions significantly increased their "Assist" behaviors (discuss cessation techniques, help patient set a quit date, and provide cessation materials) and reported fewer perceived barriers to delivering the intervention as compared with hygienists in DT. An economic analysis suggests that SS is more cost-effective than PI.

Women helping chewers: partner support and smokeless tobacco cessation.

Data from 363 male smokeless tobacco users and their romantic partners were analyzed to discern the role of support in cessation. Women reported playing a part in enrollment (71%), and more than half examined program materials or discussed cessation activities with the chewers. Women's reports of delivered support correlated substantially with men's experience of received support. Men's received positive support predicted abstinence at 6-month follow-up (odds ratio = 1.29, confidence interval = 1.03-1.61) and more than 24 hr of abstinence for those still using tobacco at 6 months (odds ratio = 1.75, confidence interval = 1.30-2.36) and moderated the effect of baseline depression and addiction on abstinence. Women played a major role through all stages of cessation.