Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift.

Bayesian adaptive designs with response adaptive randomization (RAR) have the potential to benefit more participants in a clinical trial. While there are many papers that describe RAR designs and results, there is a scarcity of works reporting the details of RAR implementation from a statistical point exclusively. In this paper, we introduce the statistical methodology and implementation of the trial Changing the Default (CTD). CTD is a single-center prospective RAR comparative effectiveness trial to compare opt-in to opt-out tobacco treatment approaches for hospitalized patients. The design assumed an uninformative prior, conservative initial allocation ratio, and a higher threshold for stopping for success to protect results from statistical bias. A particular emerging concern of RAR designs is the possibility that time trends will occur during the implementation of a trial. If there is a time trend and the analytic plan does not prespecify an appropriate model, this could lead to a biased trial. Adjustment for time trend was not pre-specified in CTD, but post hoc time-adjusted analysis showed no presence of influential drift. This trial was an example of a successful two-armed confirmatory trial with a Bayesian adaptive design using response adaptive randomization.

Hospital-Initiated Smoking Cessation Among Patients Admitted with Behavioral Health Conditions.

BACKGROUND: Smoking rates among people living with behavioral health conditions (BHC) range from 30 to 65% and are 2-4 times higher than rates found in the general population. Starting tobacco treatment during a hospital stay is effective for smoking cessation, but little is known regarding treatment response among inpatients with BHC. OBJECTIVE: This study pooled data across multiple clinical trials to determine the relative success in quitting among participants with BHC compared to other study participants. PARTICIPANTS: Adults who smoke (≥ 18 years old) from five hospital-based smoking cessation randomized clinical trials. DESIGN: A retrospective analysis using data from the electronic health record to identify participants with primary diagnoses related to BHC. Recruitment and data analysis were conducted from 2011 to 2016. We used propensity score matching to pair patients with BHC to those with similar characteristics and logistic regression to determine differences between groups. MEASURES: The main outcome was self-reported 30-day abstinence 6 months post-discharge. RESULTS: Of 6612 participants, 798 patients had a BHC-related primary diagnosis. The matched sample included 642 pairs. Nearly 1 in 3 reported using tobacco medications after hospitalization, with no significant difference between patients with and without BHC (29.3% vs. 31.5%; OR (95% CI) = 0.90 (0.71, 1.14), p = 0.40). Nearly 1 in 5 patients with BHC reported abstinence at 6 months; however, their odds of abstinence were 30% lower than among people without BHC (OR (95% CI) = 0.70 (0.53,0.92), p = 0.01). CONCLUSION: When offered tobacco treatment, hospitalized patients with BHC were as likely as people without BHC to accept and engage in treatment. However, patients with BHC were less likely to report abstinence compared to those without BHC. Hospitals are a feasible and promising venue for tobacco treatment among inpatients with BHC. More studies are needed to identify treatment approaches that help people with BHC achieve long-term abstinence.

The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial.

Importance: Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries. Objective: To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco. Design, Setting, and Participants: In Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021. Interventions: At bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling. Main Outcomes and Measures: The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization. Results: Of a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group. Conclusions and Relevance: In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation. Trial Registration: ClinicalTrials.gov Identifier: NCT02721082.

Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.

Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen's d measure of effect size to evaluate differences. Results: Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen's d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen's d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance. Conclusions: The modified Zelen's design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.

Hospital-based tobacco treatment for inpatients with a history of cancer.

OBJECTIVE: To describe treatment engagement and outcomes of patients who smoke with cancer and received tobacco cessation treatment during hospitalization. METHOD: We analyzed treatment engagement and cessation outcomes for hospitalized patients who smoke with a current or former history of cancer receiving treatment from an inpatient tobacco treatment service between July, 2018 to October, 2019. RESULTS: The service treated 407 inpatients. Patients had an overall high level of interest in quitting (7.6, 0-10 scale). One in three accepted cessation pharmacotherapies during hospitalization or at discharge (35%) and/or referral to the state tobacco quitline (37%). Of 189 patients reached at one-month post-discharge, 73 (39%) reported tobacco abstinence (18% intent to treat-ITT-quit rate); 35.5% had used cessation pharmacotherapy and 6.5% had engaged in quitline counseling. Of 151 patients reached at 6 months post-discharge, 29% reported abstinence (11%, ITT). CONCLUSION: Inpatients with a history of cancer are interested in quitting. Post-discharge quit rates and pharmacotherapy use were high but quitline use was low. Hospitalization is an under-utilized, prime treatment opportunity and teachable moment for people with a history of cancer who continue to use tobacco.

Which hospitalized smokers receive a prescription for quit-smoking medication at discharge? A secondary analysis of a smoking cessation randomized clinical trial.

OBJECTIVE: To determine the prevalence and predictors of receiving a smoking cessation medication prescription at discharge. METHODS: Retrospective analysis of ongoing Human Studies Committee-approved clinical trial data at large tertiary care center, The University of Kansas Medical Center. Patients included were smokers over 18, either Spanish or English speaking, those admitted between October 1, 2016 through May 31, 2018. Other eligibility criteria include access to a telephone or mobile phone, not currently be pregnant or breastfeeding, have no significant co-morbidity that precludes participation (acute, life-threatening illness, and communication barriers such as tracheal tube or altered mental status). Those included in this analysis were those randomized into the trial who expressed interest in receiving a smoking cessation medication prescription at discharge. RESULTS: Two hundred fourteen patients were recommended a prescription by their smoking cessation counselor, 88 patients (41.12%) were approved a prescription at discharge. Out of those approved, 50.70 (14.05 SD) was the average age, 12.84 (8.47 SD) was the average number of cigarettes used per day, 47 patients (53.41%) were White, 49 patients (55.68%) were admitted through the emergency department, 55 patients (62.50%) had used smoking cessation medication in the past, 49 patients (55.68%) had used inpatient smoking cessation, 36 patients (40.91%) had Medicaid. A binary logistic regression determined to show insurance status (P = 0.042) and use of inpatient smoking cessation medication use (P < 0.001) as statistically significant predictors of receiving a prescription at discharge. CONCLUSION: It was determined that among the population recommended for medication, 41.12% actually received a prescription at discharge. The variables of "health insurance status" and "use of inpatient smoking cessation medication" demonstrated to be predictors of receiving a prescription. It is important to further study this as many patients rely on a prescription to afford these medications that are useful in a quit attempt.

Rapid relapse to smoking following hospital discharge.

Many of nearly 7 million smokers who are hospitalized each year plan to stay quit after they leave the hospital. Most, however, relapse after discharge. This is a secondary analysis of a large Midwestern hospital-based smoking cessation trial that occurred between July 2011 and May 2013 to better understand how quickly smokers relapse and the predictors of rapid relapse. Of 942 participants who completed follow up, 25% returned to smoking within a day after hospital discharge. Among these rapid relapses, 36.6% relapsed within one-hour of leaving the hospital, 35.3% between one and 24 h, and 28.1% relapsed one-day post-discharge. Predictors with the highest odds for rapid relapse (within a day of hospital discharge) included tobacco use during hospitalization (OR, 7.37, [95% CI, 3.85-14.13], P < 0.01); low confidence for quitting (OR, 2.07, [95% CI, 1.49-2.88], P < 0.01); and not setting a quit date (OR, 1.76, [95% CI, 1.25-2.48], P < 0.01). Other significant predictors included higher nicotine dependence, shorter length of stay, and depression. Patients who are vulnerable to rapid relapse may benefit from policies that discourage leaving the hospital to smoke. In addition, hospital interventions that target smokers' confidence in quitting, encourage setting a quit date, and addressing nicotine dependence and depression may also be effective at supporting smoker's intentions to make their pre-admission cigarette their last. Clinical Trials Registration NCT01305928.

Prevalence and predictors of quitline enrollment following hospital referral in real-world clinical practice.

Tobacco quitlines are effective, and work best for callers who receive three or more counseling sessions. Clinical settings are adopting quitline referral as a method for providing cessation support but little is known regarding enrollment and engagement following these referrals. We used data from quitline fax-back reports to describe enrollment and treatment engagement of 878 hospitalized patients who smoke who were referred via secure email to quitline at discharge. We compared patient demographics, tobacco characteristics, and treatment engagement between those enrolled and not enrolled. We conducted chi-square and t-tests to determine which variables should be included in a logistic regression to determine predictors of quitline enrollment. We did not receive fax-back reports for 25% (n = 221) of referred patients; these were excluded from all but the intent-to-treat analysis. Among patients for whom we received reports, 20.4% enrolled and accepted at least one service from the quitline. Among the 79.6% (n = 523) of patients who smoke not enrolled, most (78.3%; n = 410) were classified by the quitline as unreachable. Age (p = .006), smoking within 30 min of waking (p = .005), and interest in quitting (p = .008) were significant predictors of quitline enrollment. Using an intent to treat analysis, 11.4% (n = 100) of all referred patients were enrolled and accepted a single or multi-call programs; 4.2% (n = 37) of all referred patients enrolled and accepted a multi-call counseling program. Quitlines are a pillar of U.S. tobacco treatment. For quitlines to fulfill their potential, quitlines and hospitals must identify effective strategies for reaching and treating referred patients who smoke. Quitlines are effective and are readily available to many in advanced economy countries. Treatment engagement appears to be a barrier to quitline participation as we found few patients who were referred to the quitline actually enrolled in care. Quitlines should consider adopting alternative methods for reaching patients who smoke. Future research is warranted to determine effective solutions to breakdowns in transitions of care.

Two brief valid measures of therapeutic alliance in counseling for tobacco dependence.

Behavioral counseling is effective for smoking cessation and the psychotherapy literature indicates therapeutic alliance is key to counseling effectiveness. However, no tobacco-counseling specific measures of alliance exist that are suitable in most tobacco counseling contexts. This hinders assessment of counseling components in research and clinical practice. Based on the Working Alliance Inventory, and external expert review, we developed two alliance instruments: the 12-item and 3-item Working Alliance Inventory for Tobacco (WAIT-12 and WAIT-3). Two samples of 226 daily smokers via Amazon Mechanical Turk completed measures including demographics, tobacco characteristics, working alliance scales, and quit attempts. Both WAIT-12 and WAIT-3 had good to excellent internal consistency (0.92 and 0.88 for the WAIT-3 and 0.96 for the WAIT-12). The WAIT-12 1-factor model indicated poor fit (CFI=0.83, TLI=0.79, RMSEA=0.19, SRMR=0.09). The WAIT-12 3-factor model (CFI=0.94, TLI=0.93, RMSEA=0.11, SRMR=0.04) was indicative of acceptable fit. Both the WAIT-12 and the WAIT-3 were significantly associated with participants' self-reported cigarettes per day, quit attempts, and cessation. Initial validation of the WAIT-12 and WAIT-3 indicates they are psychometrically sound measures of tobacco dependence counseling alliance. The WAIT-3 provides brevity; it can be administered in under 1min. The WAIT-12 allows for assessment of specific components of therapeutic alliance. Overall, these instruments should allow for better measurement of alliance in clinical services and research.

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

INTRODUCTION: The prevalence of smoking among people living with HIV/AIDS (PLWHA) remains higher than the general population. Life expectancy among PLWHA has increased over the past decade, however, PLWHA who smoke will die younger than their non-smoking peers. The primary aim of this pilot study was to examine the effects of warm handoff versus fax referral to the quitline for smoking cessation among hospitalized smokers living with HIV/AIDS. METHODS: 25 smokers with a diagnosis of HIV/AIDS hospitalized at a Midwestern academic medical center in 2012-2013 (19 male; mean age=47.7; 48% African-American) were identified, approached, and randomized to one of two treatment arms. At the bedside for patients in warm handoff, staff telephoned the quitline for on-the-spot enrollment and counseling. Participants randomized to fax were fax-referred to the quitline on the day of discharge. The quitline provided continued outpatient counseling to participants in both conditions. The main outcome was verified tobacco abstinence at 6-months post randomization. RESULTS: Enrollment and participation in quitline counseling was high among both warm handoff (100%) and fax-referred (71.4%) PLWHA participants. Nearly all completed follow up for outcome data collection at 6months. Verified abstinent rates were 45.5% in warm handoff versus 14.3% in fax referral at 6months (not significant). CONCLUSIONS: Hospitalized smokers living with HIV/AIDS were highly engaged in quitline services. Warm handoff seems a promising intervention for hospitalized PLWHA that requires further exploration. Clinical Trials Registration NCT01305928.

Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial.

BACKGROUND: Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment "default." Current treatment guidelines recommend that providers (1) ask patients if they are willing to quit and (2) provide cessation-focused medications and counseling only to smokers who state that they are willing to quit. The default is that patients have to "opt in" to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say "yes." This drastically limits the reach of cessation services because, at any given encounter, only one in three smokers say that they are ready to quit. The objective of this study is to determine the impact of providing all smokers with tobacco-cessation treatment unless they refuse it (OPT OUT) versus current practice-screening for readiness and only offering treatment to smokers who say they are ready to quit (OPT IN). METHODS: This individually randomized clinical trial is conducted in a tertiary-care hospital. We will conduct the trial among up to 1000 randomly selected hospitalized smokers to determine the population impact of changing the treatment default, identify mediators of outcome, and determine the cost-effectiveness of this new, highly proactive approach. This is a population-based study that targets an endpoint of vital interest; applies minimal eligibility criteria to broaden generalizability; and utilizes hospital staff for interventions to ensure long-term sustainability. The study employs delayed consent and an innovative Bayesian adaptive design to evaluate a major shift in our approach to care. If effective, this change would expand the reach of tobacco-cessation treatment from 30% to 100% of smokers. DISCUSSION: Regardless of outcome, the trial will provide a model of how to alter and evaluate the impact of health care defaults. If OPT OUT proves to be more effective, it will expand the population eligible for cessation treatment by over 300%. It will also simplify the tobacco-cessation treatment algorithm, and relieve busy health care providers of the burden of evaluating readiness to quit. TRIAL REGISTRATION: Clinical Trials Registration, ID: NCT02721082 . Registered on 22 March 2016.

Warm Handoff Versus Fax Referral for Linking Hospitalized Smokers to Quitlines.

INTRODUCTION: Few hospitals treat patients' tobacco dependence. To be effective, hospital-initiated cessation interventions must provide at least 1 month of supportive contact post-discharge. STUDY DESIGN: Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014-June 2015. SETTING/PARTICIPANTS: The study was conducted in two large Midwestern hospitals. Participants included smokers who were aged ≥18 years, planned to stay quit after discharge, and spoke English or Spanish. INTERVENTION: Hospital-based cessation counselors delivered the intervention. For patients randomized to warm handoff, staff immediately called the quitline from the bedside and handed the phone to participants for enrollment and counseling. Participants randomized to fax were referred on the day of hospital discharge. MAIN OUTCOME MEASURES: Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness. RESULTS: Significantly more warm handoff than fax participants enrolled in quitline (99.6% vs 59.6%; relative risk, 1.67; 95% CI=1.65, 1.68). One in four (25.4% warm handoff, 25.3% fax) were verified to be abstinent at 6-month follow-up; this did not differ significantly between groups (relative risk, 1.02; 95% CI=0.82, 1.24). Cessation medication use in the hospital and receipt of a prescription for medication at discharge did not differ between groups; however, significantly more fax participants reported using cessation medication post-discharge (32% vs 25%, p=0.01). The average incremental cost-effectiveness ratio of enrolling participants into warm handoff was $0.14. Hospital-borne costs were significantly lower in warm handoff than in fax ($5.77 vs $9.41, p<0.001). CONCLUSIONS: One in four inpatient smokers referred to quitline by either method were abstinent at 6 months post-discharge. Among motivated smokers, fax referral and warm handoff are efficient and comparatively effective ways to link smokers with evidence-based care. For hospitals, warm handoff is a less expensive and more effective method for enrolling smokers in quitline services.

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

BACKGROUND: Most persons living with HIV smoke cigarettes and tend to be highly dependent, heavy smokers. Few such persons receive tobacco treatment, and many die from tobacco-related illness. Although advancements in antiretroviral therapy (ART) have increased the quality and quantity of life, the health harms from tobacco use diminish these gains. Without cessation assistance, thousands will benefit from costly ART, only to suffer the consequences of tobacco-related disease and death. A study was conducted to examine in detail inpatient tobacco treatment for smokers with HIV. METHODS: Data collected at hospital admission and data collected by tobacco treatment specialists were examined retrospectively for all inpatients with HIV who were admitted to an academic medical center for a five-year period. Specifically, the prevalence of cigarette smoking, factors predictive of referral to tobacco treatment, referral for tobacco treatment, treatment participation, and abstinence at six months posttreatment were measured. Differences in referral and treatment participation between all smokers and smokers with HIV were also assessed. RESULTS: Among the 422 admitted persons with HIV, 54.5% smoked and 21.7% were referred to inpatient tobacco treatment services. Substance abuse and tobacco-related diagnoses were predictive of referral to inpatient tobacco treatment specialists. Among the 14 treatment participants reached for follow-up, 11 (78.6%) made quit attempts and 3 (21.4%) reported abstinence. Smokers with HIV were less likely to be referred to and treated by tobacco treatment services than all smokers admitted during the same time frame. CONCLUSIONS: Although tobacco is a major cause of mortality, few smokers with HIV are offered treatment during hospitalization. Those who are treated attempt to quit. Hospitalization offers a prime opportunity for initiating smoking cessation among those with HIV.

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.

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.

Predictors of early versus late smoking abstinence within a 24-month disease management program.

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.