Pharmaceutical assistance programs to support smoking cessation medication access.

OBJECTIVES: Rural smokers are more likely to be uninsured and live in poverty, which may pose significant cost barriers to accessing smoking cessation medications. As part of a randomized clinical trial, we provided support to connect low-income smokers with the use of pharmaceutical assistance programs (PAPs) to improve medication access. METHODS: Study participants were rural smokers enrolled in a randomized clinical trial testing in-office telemedicine versus telephone-based approaches to deliver counseling sessions. For potentially qualified participants, we developed a system to connect them with PAPs that provided smoking cessation medications at low or no cost. Participants reported medication utilization 3 and 6 months after randomization. RESULTS: Of the 560 study participants, 312 (55.7%) met initial screening criteria for PAP eligibility. Of those eligible, 104 (33.3%) initiated a PAP application, with 49 (15.7%) completing the application and ultimately receiving medications through the programs. Despite the availability of assistance with the PAP application process, overall medication use among those that were eligible for PAP was significantly lower than among participants with higher incomes or access to prescription insurance (60.4% vs. 51.3%; P = 0.04). Abstinence among PAP-eligible smokers was also lower at the 3-month follow-up (P = 0.01), but this difference was not present at the 6- and 12-month follow-up surveys. CONCLUSION: With substantial assistance, some low-income smokers without prescription insurance can get effective smoking cessation medications through PAPs, but overall access remains worse than among those with higher incomes or prescription insurance.

Commitment and capacity for providing evidence-based tobacco treatment in US drug treatment facilities.

BACKGROUND: Although people with mental illness, including substance use disorders, consume 44% of cigarettes in the United States, few facilities provide tobacco treatment. This study assesses staff- and facility-level drivers of tobacco treatment in substance use treatment. METHODS: Surveys were administered to 405 clinic directors selected from a comprehensive inventory of 3800 US outpatient facilities. The main outcome was the validated 7-item Index of Tobacco Treatment Quality. Other measures included the validated Tobacco Treatment Commitment Scale and indicators of facility resources for providing tobacco treatment. RESULTS: Stepwise model selection was used to determine the relationship between capacity/resources and treatment quality. The final model retained 7 items and had good fit (adjusted R2 = 0.43). Four capacities significantly predicted treatment quality. Structural equation modeling (SEM) was used to test the impact of staff commitment on treatment quality; the model had good fit and the relationship was significant (comparative fit index [CFI] = 0.951, root mean square error of approximation [RMSEA] = 0.054). Adding the 7 capacity/resources maintained similar model fit (CFI = 0.922, RMSEA = 0.053). Staff commitment was slightly strengthened in this model, with a rise in parameter estimate from 0.449 to 0.560. All resource/capacity items were also significant predictors of treatment quality; the strongest was receiving training in how to provide tobacco treatment (0.360), followed by dedicated staff time (0.279) and having a policy that requires staff to offer treatment (0.272). CONCLUSIONS: Staff commitment to providing tobacco treatment was the strongest predictor of tobacco treatment quality, followed by resources for providing treatment. Interventions to change staff attitudes and improve resources for tobacco treatment have the strongest potential for improving quality of care.

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 $45.46, SD 31.50) and Phone (US $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).

Design and participant characteristics of a randomized-controlled trial of telemedicine for smoking cessation among rural smokers.

INTRODUCTION: In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiveness and cost-effectiveness of integrated telemedicine counseling delivered by 2-way webcams mounted on desktop computers in participant's physician office examining rooms (ITM) versus quitline counseling delivered by telephone in participant's homes (Phone) for helping rural smokers quit. METHODS/DESIGN: C2Q was implemented in twenty primary care and safety net clinics. Integrated telemedicine consisted of real-time video counseling, delivered to patients in their primary care physician's (PCP) office. Phone counseling, was delivered to patients in their homes. All participants received educational materials and guidance in selecting cessation medications. RESULTS: The 566 participants were predominantly Caucasian (92%); 9% were Latino. Most (65%) earned <200% of Federal Poverty Level. One out of three lacked home internet access, 40% were not comfortable using computers, and only 4% had been seen by a doctor via telemedicine in the past. Hypertension, chronic lung disease, and diabetes were highly prevalent. Participants smoked nearly a pack a day and were highly motivated to quit. DISCUSSION: C2Q is reaching a rural low-income population, with comorbid chronic diseases, that would benefit greatly from quitting smoking. ITM is a good delivery model, which integrates care by holding counseling sessions in the patient's PCP office and keeps the primary care team updated on patients' progress. CLINICAL TRIALS REGISTRATION: NCT00843505.

Staff commitment to providing tobacco dependence in drug treatment: Reliability, validity, and results of a national survey.

Although most people in treatment for illicit drug use smoke cigarettes, few facilities offer any form of treatment for tobacco dependence. One reason for this may be that drug treatment staff have varying levels of commitment to treat tobacco. We developed and validated a 14-item Tobacco Treatment Commitment Scale (TTCS), using 405 participants in leadership positions in drug treatment facilities. We first conducted a confirmatory factor analysis to evaluate 4 a priori domains suggested by our original set of 38 items-this did not produce a good fit (comparative fit index [CFI] = 0.782, root mean square error of approximation [RMSEA] = 0.067). We then conducted a series of exploratory factor analyses to produce a more precise and reliable scale. The final confirmatory factor analysis indicated a 3-factor solution, produced a good fit (CFI = 0.950, RMSEA = 0.058), and had substantial unified reliability of 0.975. The final TTCS contained 14 items in 3 domains: "Tobacco is less harmful than other drugs," "It's not our job to treat tobacco," and "Tobacco treatment will harm clients." These constructs account for most of the variance in the survey items and emerged as major sentiments driving staff commitment to providing tobacco services. The TTCS can be used to understand the role of staff attitudes in the adoption of tobacco services in this important treatment setting.

Capacity of US drug treatment facilities to provide evidence-based tobacco treatment.

Although people with drug problems consume a large proportion of cigarettes smoked in the United States, few drug treatment facilities offer tobacco treatment. Our analysis of 405 facilities showed that most had the skills but few had policies, leadership, or financial resources to provide evidence-based tobacco treatment. For-profits reported significantly fewer tobacco treatment resources than nonprofits. The Affordable Care and Mental Health Parity acts will improve treatment access for drug-dependent persons. To realize these acts' full promise, policymakers should ensure that clients have access to tobacco treatment.

The index of tobacco treatment quality: development of a tool to assess evidence-based treatment in a national sample of drug treatment facilities.

BACKGROUND: Quitting smoking improves health and drug use outcomes among people in treatment for substance abuse. The twofold purpose of this study is to describe tobacco treatment provision across a representative sample of U.S. facilities and to use these data to develop the brief Index of Tobacco Treatment Quality (ITTQ). METHODS: We constructed survey items based on current tobacco treatment guidelines, existing surveys, expert input, and qualitative research. We administered the survey to a stratified sample of 405 facility administrators selected from all 3,800 U.S. adult outpatient facilities listed in the SAMHSA Inventory of Substance Abuse Treatment Services. We constructed the ITTQ with a subset of 7 items that have the strongest clinical evidence for smoking cessation. RESULTS: Most facilities (87.7%) reported that a majority of their clients were asked if they smoke cigarettes. Nearly half of facilities (48.6%) reported that a majority of their smoking clients were advised to quit. Fewer (23.3%) reported that a majority of their smoking clients received tobacco treatment counseling and even fewer facilities (18.3%) reported a majority of their smoking clients were advised to use quit smoking medications. The median facility ITTQ score was 2.57 (on a scale of 1-5) and the ITTQ displayed good internal consistency (Cronbach's alpha = .844). Moreover, the ITTQ had substantial test-retest reliability (.856), and ordinal confirmatory factor analysis found that our one-factor model for ITTQ fit the data very well with a CFI of 0.997 and an RMSEA of 0.042. CONCLUSIONS: The ITTQ is a brief and reliable tool for measuring tobacco treatment quality in substance abuse treatment facilities. Given the clear-cut room for improvement in tobacco treatment, the ITTQ could be an important tool for quality improvement by identifying service levels, facilitating goal setting, and measuring change.

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

BACKGROUND: Post-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. METHODS: The 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. DISCUSSION: If 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 REGISTRATION: Clinical Trials Registration NCT01305928.

Understanding the drug treatment community's ambivalence towards tobacco use and treatment.

BACKGROUND: Most clients in drug treatment smoke cigarettes, but few facilities provide treatment for tobacco dependence. We identify subjective experiences and social processes that may influence facility adoption of tobacco treatment policies and practices. METHODS: Cross-sectional, semi-structured interviews were conducted with staff, directors and clients of 8 drug treatment facilities in the Midwestern U.S. We assembled a purposive sample stratified by ownership, methadone provision, and treatment service provision. We conducted in-person interviews with clinic directors and 54 staff and clients and employed a mixed-method analytic approach. RESULTS: Facility policies and philosophy related to tobacco differed from those regarding alcohol and other drugs. Participants suggested facilities may not treat tobacco dependence because it does not create legal and social problems that force clients into treatment. Tobacco dependence treatment falls outside of a core function of drug treatment, which is to help clients fix legal problems caused by their drug use. Moreover, proactively treating clients for tobacco dependence creates strong ambivalence amongst staff and directors. On the one hand, staff smoking would violate core principles of drug treatment (i.e., the importance of staff abstinence from drugs of abuse); on the other, staff who smoke feel their personal rights and jobs are threatened. This situation creates strong incentives for staff to resist adoption of tobacco dependence treatment. Unlike other studies, the fear of jeopardising clients' abstinence from other drugs did not emerge as a downside for treating tobacco dependence. CONCLUSIONS: International and national trends will probably increase the pressure to treat tobacco dependence during drug treatment. However, the U.S. context of drug treatment, as a patchwork, under-funded industry with high employee turnover, may undermine true adoption. At present, many facility staff resolve their ambivalence by reporting they "offer" treatment, but actually providing none. To facilitate dissemination of service provision, it may be useful to identify incentives for U.S. facilities that are closely aligned with the criminal justice system, help facilities define policies and treatment roles for staff who smoke, and better define the role of facilities in preventing morbidity and mortality.

How is tobacco treatment provided during drug treatment?

The purpose of this study was to obtain descriptions of tobacco treatment services across different substance abuse treatment settings. We conducted mixed-method assessments in eight facilities among eight directors, 25 staff, 29 clients, and 82 client charts. Measures included systems assessment, chart reviews, and semistructured interviews. Although many programs reported they offer key components of evidence-based treatment, few actually provided any treatment and none did so systematically. Many addressed tobacco as part of drug education or part of a health promotion session. Chart reviews suggested that provision of tobacco treatment is rare. By many reports, clients had to specifically request treatment and few staff reported encouraging unmotivated smokers to quit. Systems to facilitate consistent, evidence-based tobacco treatment and to implement quality improvement were nonexistent. The findings imply that drug treatment facilities may need to build capacity in several domains to deliver care that is consistent with national guidelines.