Laura M. Mussulman

Effect of varying levels of disease management on smoking cessation: a randomized trial.

Context Smoking cessation is difficult and may require repeated or intensive interventions. Contribution In this multicenter trial, 750 primary care patients who smoked at least 10 cigarettes per day were randomly assigned to pharmacotherapy (nicotine patch or bupropion), pharmacotherapy supplemented with up to 2 calls from trained counselors, or pharmacotherapy supplemented with up to 6 counseling calls. Utilization of the interventions, which were offered every 6 months for 2 years, declined over time. Smoking abstinence rates at 2 years were 23%, 24%, and 28% in the 3 groups. Caution Pharmacotherapy was free. Smoking abstinence was self-reported. The Editors Cigarette smoking is a chronic illness characterized by repeated cycles of quit attempts and relapse. Most models for addressing smoking cessation are based on single, short-term interventions lasting only a few weeks or months (1). Although most smokers will not quit after a single intervention, few studies have addressed the chronic nature of nicotine dependence by providing systematic, repetitive treatment opportunities (1). Providing treatment only to smokers who are already prepared to quit further limits the reach of current smoking cessation interventions (2). New models of chronic disease care might provide an alternative approach for expanding the reach and effectiveness of smoking cessation efforts (3). Physicians are in direct contact with approximately 70% of smokers each year (4, 5). Their potential role in promoting smoking cessation has been well delineated and incorporated into current clinical practice guidelines (1). With the development of new, more effective prescription pharmacotherapy for smoking cessation, the role of primary care practices in promoting smoking cessation is now more important than ever. Unfortunately, only half of the smokers who see their physicians are asked about their smoking (6), and even fewer receive advice from their health care provider to quit or receive pharmacotherapy or follow-up (4, 7). Smoking cessation counseling competes with other pressing clinical tasks, and beyond brief advice, many physicians feel they are too busy to routinely and repeatedly counsel participants who smoke (810). To assist primary care physicians in the treatment of rural smokers, we developed KanQuit, a smoking cessation program based on the chronic care model (4), which integrates principles of disease management into the treatment of smokers seen in rural primary care. Our objective was to enroll smokers, regardless of their willingness to quit, into a disease registry and compare cessation rates among smokers who received pharmacotherapy alone or combined with either moderate-intensity or high-intensity disease management that includes counseling and provider feedback. Methods Design Overview We did a randomized, single-blind trial of varying levels of disease management for smoking cessation. We recruited participants who smoked more than 10 cigarettes per day from rural primary care clinics across Kansas and randomly assigned them to receive pharmacotherapy alone, pharmacotherapy supplemented by 1 to 2 counseling calls every 6 months (moderate-intensity disease management), or pharmacotherapy supplemented by up to 6 counseling calls every 6 months (high-intensity disease management). For recipients of moderate-intensity and high-intensity disease management, we faxed periodic progress reports to their physician. We offered all participants free pharmacotherapy (either bupropion or transdermal nicotine patch) every 6 months. We enrolled participants from June 2004 to October 2005 and followed them for 24 months, completing follow-up in December 2007. All participants provided written informed consent. The University of Kansas Medical Centers Human Subjects Committee approved the study. Setting and Participants We conducted our study in 50 rural primary care practices in the Kansas Physicians Engaged in Prevention Research network (11). As part of a rural primary care research experience, trained medical students systematically screened participants, identified smokers, and recruited them for this study, regardless of their interest in quitting (12). We considered smokers eligible if they had a primary care physician who participated in this study; were older than 18 years; smoked more than 10 cigarettes per day for at least 1 year and for at least 25 of the past 30 days; spoke English; and had a telephone. We excluded smokers if they were pregnant or planned to become pregnant, planned to move out of the study area, had signs of dementia or mental illness that would preclude participation, or lived with a smoker already enrolled in the study. Of the 1827 smokers we screened, 61% met criteria for study entry (Figure 1). Of these, we enrolled 67%. Figure 1. Study flow diagram. HDM = high-intensity disease management; MDM = moderate-intensity disease management; PM = pharmacotherapy management. Randomization and Interventions Participant Randomization Randomization occurred at the participant level. A computer-generated random-number table was used to generate allocation cards in blocks of 24, with allocation equally distributed across treatment groups. To conceal allocation, we placed these cards in sequentially numbered, opaque, sealed envelopes. After research assistants verified participant eligibility and completed the baseline assessment, the project director opened the next sequential sealed envelope and determined the participants treatment allocation. One of 9 counselors trained in smoking cessation and motivational interviewing (12) conducted all interventions from a single central site. We assigned participants to counselors without regard to practice site. Pharmacotherapy At baseline, all smokers received a health education mailing that consisted of a welcome letter, information about the use of bupropion and the nicotine patch for smoking cessation, and copies of You Can Quit Smoking: Consumer Guide (13) and When Smokers QuitThe Health Benefits Over Time (14). At baseline and at 6, 12, and 18 months, participants received a mailed offer for free pharmacotherapy that consisted of either a 6-week course of a nicotine patch (21 mg/d) or a 7-week course of sustained-release bupropion (150 mg twice daily). Participants interested in using either medication could return a postage-paid postcard or call a toll-free number. We screened all participants who requested pharmacotherapy for potential contraindications (15). Participants with absolute contraindications for a given drug were ineligible to receive that drug but were offered the option of receiving the other drug. Participants with contraindications to both drugs were not eligible to receive medication from the study but could participate in all other aspects of the intervention. For participants who requested bupropion and those with relative contraindications to the nicotine patch, research staff faxed a prescription request to their primary care physicians. This prescription request delineated any relative contraindications or potential drug interactions. For these participants, their physicians made the final assessment of the appropriateness of the bupropion or the patch. For participants without contraindications to the nicotine patch or on receipt of a faxed, signed prescription, the bupropion or patches were mailed to the participant along with instructions for use. Disease Management In addition to pharmacotherapy, the moderate-intensity and high-intensity disease management groups received educational support, telephone counseling, and periodic progress reports with counseling suggestions faxed to their physician. Every 6 months, they received a KanQuit newsletter that addressed tips on quitting smoking, talking with their physician about smoking, and using pharmacotherapy for cessation. The newsletters were personalized to include study updates, counselor photographs, physician feature stories, and testimonials of participants who had quit smoking. We offered participants assigned to moderate-intensity disease management up to 2 telephone-based counseling sessions every 6 months (1 session to promote a quit attempt and 1 additional follow-up session for those who made a quit attempt). We offered participants assigned to high-intensity disease management up to 6 counseling calls every 6 months to either promote quitting or prevent relapse. We scheduled calls at the participants convenience, and they varied according to the participants quit plan but followed a rough schedule of calls at 1, 3, 6, 9, and 16 weeks after the onset of each 6-month treatment cycle. Counselors used motivational interviewing techniques and followed a semistructured protocol to promote a cessation attempt or, for abstinent smokers, to encourage relapse prevention. During counseling calls, case managers reminded participants about the availability of pharmacotherapy and, for interested participants, provided immediate support for acquiring either the nicotine patch or bupropion, as described previously. We faxed personalized progress reports with suggestions for interventions to the participants physician after the first counseling call (both moderate-intensity and high-intensity disease management participants) and after the last counseling call (high-intensity disease management participants only) during each 6-month cycle. We faxed additional progress reports to the participants physician whenever the moderate-intensity or high-intensity disease management participant set a quit date. Outcomes, Measurements, and Follow-up Research assistants who were blinded to treatment group assignment conducted assessments by telephone at baseline and at 6, 12, 18, and 24 months. Primary Outcome The primary outcome measure was self-reported 7-day abstinence at 24 months, defined as not having smoked a cigarette during the previous 7 days. Although self-reported abstinence has been co

Understanding smoking cessation in rural communities.

CONTEXT Rural communities are adversely impacted by increased rates of tobacco use. Rural residents may be exposed to unique communal norms and other factors that influence smoking cessation. PURPOSE This study explored facilitating factors and barriers to cessation and the role of rural health care systems in the smoking-cessation process. METHODS Focus groups were conducted with smokers (N = 63) in 7 Midwestern rural communities. Qualitative analysis and thematic coding of transcripts was conducted. FINDINGS Three levels of pertinent themes--intrinsic, health-system resource, and community/social factors--were identified. Intrinsic factors facilitating cessation included willingness to try various cessation methods, beliefs about consequences of continuing smoking (eg, smoking-related illnesses), and benefits of quitting (eg, saving money). Intrinsic barriers included skepticism about resources, low self-efficacy and motivation for smoking cessation, concern about negative consequences of quitting (eg, weight gain), and perceived benefits of continued smoking (eg, enjoyment). Key health-system resource facilitators were pharmacotherapy use and physician visits. Resource barriers included infrequent physician visits, lack of medical/financial resources, limited local smoking-cessation programs, and lack of knowledge of existing resources. In terms of community/social factors, participants acknowledged the negative social impact/image of smoking, but also cited a lack of alternative activities, few public restrictions, stressors, and exposure to other smokers as barriers to cessation. CONCLUSIONS Smokers in rural communities face significant challenges that must be addressed. A multilevel model centered on improving access to health care system resources while addressing intrinsic and community/social factors might enhance smoking-cessation interventions and programs in rural communities.

Design and baseline characteristics from the KAN-QUIT disease management intervention for rural smokers in primary care

OBJECTIVE To describe the design, implementation, baseline data, and feasibility of establishing a disease management program for smoking cessation in rural primary care. METHOD The study is a randomized clinical trial evaluating a disease management program for smoking cessation. The intervention combined pharmacotherapy, telephone counseling, and physician feedback, and repeated intervention over two years. The program began in 2004 and was implemented in 50 primary care clinics across the State of Kansas. RESULTS Of eligible patients, 73% were interested in study participation. 750 enrolled participants were predominantly Caucasian, female, employed, and averaged 47.2 years of age (SD=13.1). In addition to smoking, 427 (57%) had at least one additional major risk factor for cardiovascular disease (diabetes, hypertension, high cholesterol, heart disease or stroke). Participants smoked on average 23.7 (SD=10.4) cigarettes per day, were contemplating (61%) or preparing to quit (30%), were highly motivated and confident of their ability to quit smoking, and reported seeing their physicians multiple times in the past twelve months (Median=3.50; Mean=5.48; SD=6.58). CONCLUSION Initial findings demonstrate the willingness of patients to enroll in a two-year disease management program to address nicotine dependence, even among patients not ready to make a quit attempt. These findings support the feasibility of identifying and enrolling rural smokers within the primary care setting.

Correlates of Home Smoking Restrictions Among Rural Smokers

The prevalence of smoking is greater and smoking restrictions are less common in rural areas in comparison to urban areas. Consequently, rural smokers and their families are at increased risk for adverse health consequences from smoking. The presence of home smoking restrictions (i.e., limiting or banning cigarette smoking in the home) can be a mediator for smoking cessation and can reduce health risks for those who live with smokers. The purpose of the present study was to identify correlates of home smoking restrictions among rural smokers. We surveyed 472 smokers from 40 rural Kansas primary care practices who were enrolled in a smoking cessation intervention study. We assessed the prevalence of home smoking restrictions and examined the relationship between such restrictions, demographic variables, comorbid diagnoses, and psychosocial measures of smoking abstinence self-efficacy and motivation to quit. Complete home smoking restrictions were found among 25.4% of rural smokers with an additional 28.3% reporting some restrictions. Restrictions were associated with younger age, higher controlled motivation to quit (i.e., motivation from external pressure), the presence of children under age 6 years living in the home, fewer friends who smoke, and a partner who does not smoke. Smokers with a comorbid diagnosis of high cholesterol, chronic lung disease, or heart disease were less likely to have restrictions. Most smokers in rural primary care practices do not have home smoking restrictions, particularly those without children or a nonsmoking partner and those with significant risk factors for smoking-related illnesses. These patients may be critical targets for broaching issues of home smoking restrictions.

Comparative and cost effectiveness of telemedicine versus telephone counseling for smoking cessation.

Background In rural America, cigarette smoking is prevalent and health care providers lack the time and resources to help smokers quit. Telephone quitlines are important avenues for cessation services in rural areas, but they are poorly integrated with local health care resources. Objective The intent of the study was to assess the comparative effectiveness and cost effectiveness of two models for delivering expert tobacco treatment at a distance: telemedicine counseling that was integrated into smokers’ primary care clinics (Integrated Telemedicine—ITM) versus telephone counseling, similar to telephone quitline counseling, delivered to smokers in their homes (Phone). Methods Smokers (n=566) were recruited offline from 20 primary care and safety net clinics across Kansas. They were randomly assigned to receive 4 sessions of ITM or 4 sessions of Phone counseling. Patients in ITM received real-time video counseling, similar to Skype, delivered by computer/webcams in clinic exam rooms. Three full-time equivalent trained counselors delivered the counseling. The counseling duration and content was the same in both groups and was available in Spanish or English. Both groups also received identical materials and assistance in selecting and obtaining cessation medications. The primary outcome was verified 7-day point prevalence smoking abstinence at month 12, using an intent-to-treat analysis. Results There were no significant baseline differences between groups, and the trial achieved 88% follow-up at 12 months. Verified abstinence at 12 months did not significantly differ between ITM or Phone (9.8%, 27/280 vs 12%, 34/286; P=.406). Phone participants completed somewhat more counseling sessions than ITM (mean 2.6, SD 1.5 vs mean 2.4, SD 1.5; P=.0837); however, participants in ITM were significantly more likely to use cessation medications than participants in Phone (55.9%, 128/280 vs 46.1%, 107/286; P=.03). Compared to Phone participants, ITM participants were significantly more likely to recommend the program to a family member or friend (P=.0075). From the combined provider plus participant (societal) perspective, Phone was significantly less costly than ITM. Participants in ITM had to incur time and mileage costs to travel to clinics for ITM sessions. From the provider perspective, counseling costs were similar between ITM (US

Using “warm handoffs” to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial

45.46, SD 31.50) and Phone (US

The Impact of Repeated Cycles of Pharmacotherapy on Smoking Cessation: A Longitudinal Cohort Study

49.58, SD 33.35); however, total provider costs varied widely depending on how the clinic space for delivering ITM was valued. Conclusions Findings did not support the superiority of ITM over telephone counseling for helping rural patients quit smoking. ITM increased utilization of cessation pharmacotherapy and produced higher participant satisfaction, but Phone counseling was significantly less expensive. Future interventions could combine elements of both approaches to optimize pharmacotherapy utilization, counseling adherence, and satisfaction. Such an approach could commence with a telemedicine-delivered clinic office visit for pharmacotherapy guidance, and continue with telephone or real-time video counseling delivered via mobile phones to flexibly deliver behavioral support to patients where they most need it—in their homes and communities. Trial Registration Clinicaltrials.gov NCT00843505; http://clinicaltrials.gov/ct2/show/NCT00843505 (Archived by WebCite at http://www.webcitation.org/6YKSinVZ9).

Predictors of Early Versus Late Smoking Abstinence within a 24-month Disease Management Program

BackgroundPost-discharge support is a key component of effective treatment for hospitalized smokers, but few hospitals provide it. Many hospitals and care settings fax-refer smokers to quitlines for follow-up; however, less than half of fax-referred smokers are successfully contacted and enrolled in quitline services. “Warm handoff” is a novel approach to care transitions in which health care providers directly link patients with substance abuse problems with specialists, using face-to-face or phone transfer. Warm handoff achieves very high rates of treatment enrollment for these vulnerable groups.MethodsThe aim of this study—“EQUIP” (Enhancing Quitline Utilization among In-Patients)—is to determine the effectiveness, and cost-effectiveness, of warm handoff versus fax referral for linking hospitalized smokers with tobacco quitlines. This study employs a two-arm, individually randomized design. It is set in two large Kansas hospitals that have dedicated tobacco treatment interventionists on staff. At each site, smokers who wish to remain abstinent after discharge will be randomly assigned to groups. For patients in the fax group, staff will provide standard in-hospital intervention and will fax-refer patients to the state tobacco quitline for counseling post-discharge. For patients in the warm handoff group, staff will provide brief in-hospital intervention and immediate warm handoff: staff will call the state quitline, notify them that a warm handoff inpatient from Kansas is on the line, then transfer the call to the patients’ mobile or bedside hospital phone for quitline enrollment and an initial counseling session. Following the quitline session, hospital staff provides a brief check-back visit. Outcome measures will be assessed at 1, 6, and 12 months post enrollment. Costs are measured to support cost-effectiveness analyses. We hypothesize that warm handoff, compared to fax referral, will improve care transitions for tobacco treatment, enroll more participants in quitline services, and lead to higher quit rates. We also hypothesize that warm handoff will be more cost-effective from a societal perspective.DiscussionIf successful, this project offers a low-cost solution for more efficiently linking millions of hospitalized smokers with effective outpatient treatment—smokers that might otherwise be lost in the transition to outpatient care.Trial registrationClinical Trials Registration NCT01305928

A randomized, controlled pilot study of warm handoff versus fax referral for hospital-initiated smoking cessation among people living with HIV/AIDS

Objective To examine the uptake and effectiveness of repeated offers of pharmacotherapy to promote smoking cessation

Improving Quality of Care for Hospitalized Smokers with HIV: Tobacco Dependence Treatment Referral and Utilization

INTRODUCTION Standard smoking cessation treatment studies have been limited to 6- to 12-month follow-up, and examination of predictors of abstinence has been restricted to this timeframe. The KanQuit study enrolled 750 rural smokers across all stages of readiness to stop smoking and provided pharmacotherapy management and/or disease management, including motivational interviewing (MI) counseling every 6 months over 2 years. This paper examines differences in predictors of abstinence following initial (6-month) and extended (24-month) intervention. METHODS Baseline variables were analyzed as potential predictors of self-reported smoking abstinence at Month 6 and at Month 24. Chi-square tests, 2-sample t tests, and multiple logistic regression analyses were used to identify predictors of abstinence among 592 participants who completed assessment at baseline and Months 6 and 24. RESULTS Controlling for treatment group, the final regression models showed that male gender and lower baseline cigarettes per day predicted abstinence at both 6 and 24 months. While remaining significant, the relative advantage of being male decreased over time. Global motivation to stop smoking, controlled motivation, and self-efficacy predicted abstinence at 6 months but did not predict abstinence at Month 24. In contrast, stage of change was strongly predictive of 24-month smoking status. CONCLUSIONS While the importance of some predictors of successful smoking cessation appeared to diminish over time, initial lack of interest in cessation and number of cigarettes per day strongly predicted continued smoking following a 2-year program.