Comparative Effectiveness of Postdischarge Smoking Cessation Interventions for Hospital Patients: The Helping HAND 4 Randomized Clinical Trial.

Importance: Smoking cessation interventions for hospitalized patients must continue after discharge to improve long-term tobacco abstinence. How health systems can best deliver postdischarge tobacco treatment is uncertain. Objective: To determine if health system-based tobacco cessation treatment after hospital discharge produces more long-term tobacco abstinence than referral to a community-based quitline. Design, Setting, and Participants: This randomized clinical trial was conducted September 2018 to November 2020 in 3 hospitals in Massachusetts, Pennsylvania, and Tennessee. Cigarette smokers admitted to a study hospital who received brief in-hospital tobacco treatment and wanted to quit smoking were recruited for participation and randomized for postdischarge treatment to health system-based Transitional Tobacco Care Management (TTCM) or electronic referral to a community-based quitline (QL). Both multicomponent interventions offered smoking cessation counseling and nicotine replacement therapy (NRT) for up to 3 months. Data were analyzed from February 1, 2021, to April 25, 2022. Interventions: TTCM provided 8 weeks of NRT at discharge and 7 automated calls with a hospital-based counselor call-back option. The QL intervention sent referrals from the hospital electronic health record to the state quitline, which offered 5 counseling calls and an NRT sample. Main Outcomes and Measures: The main outcome was biochemically verified past 7-day tobacco abstinence at 6 months. Self-reported point-prevalence and continuous tobacco abstinence and tobacco treatment utilization were assessed 1, 3, and 6 months after discharge. Results: A total of 1409 participants (mean [SD] age, 51.7 [12.6] years; 784 [55.6%] women; mean [SD] 16.4 [10.6] cigarettes/day) were recruited, including 706 randomized to TTCM and 703 randomized to QL. Participants were comparable at baseline, including 216 Black participants (15.3%), 82 Hispanic participants (5.8%), and 1089 White participants (77.3%). At 1 and 3 months after discharge, more TTCM participants than QL participants used cessation counseling (1 month: 245 participants [34.7%] vs 154 participants [21.9%]; 3 months: 248 participants [35.1%] vs 123 participants [17.5%]; P < .001) and pharmacotherapy (1 month: 455 participants [64.4%] vs 324 participants [46.1%]; 3 months: 367 participants [52.0%] vs 264 participants [37.6%]; P < .001). More TTCM than QL participants reported continuous abstinence for 3 months (RR, 1.30; 95% CI, 1.06-1.58) and point-prevalence abstinence at 1 month (RR, 1.22; 95% CI, 1.08-1.35) and 3 months (RR, 1.23; 95% CI, 1.09-1.37) but not at 6 months (RR, 1.14; 95% CI, 0.99-1.29). The primary outcome, biochemically verified point-prevalence abstinence at 6 months, was not statistically significantly different between groups (19.9% vs 16.9%; RR, 1.18; 95% CI, 0.92-1.50). Conclusions and Relevance: In this randomized clinical trial, biochemically verified tobacco abstinence rates were not significantly different between groups at the 6-month follow-up. However, the health system-based model was superior to the community-based quitline model throughout the 3 months of active treatment. A longer duration of postdischarge treatment may sustain the superiority of the health system-based model. Trial Registration: ClinicalTrials.gov Identifier: NCT03603496.

Understanding engagement behaviors and rapport building in tobacco cessation telephone counseling: An analysis of audio-recorded counseling calls.

INTRODUCTION: Though telephone counseling is a modality commonly used to promote health behavior change, including tobacco cessation, specific counselor and participant behaviors that indicate engagement and therapeutic alliance remain poorly characterized in the literature. We sought to explore smokers' and counselors' engagement and rapport-building behaviors in telephone counseling for smoking cessation and patterns of these behaviors by smokers' psychiatric symptoms. METHODS: The study team transcribed, audio-recorded tobacco cessation counseling calls for the presence of engagement and rapport-building behaviors among recently hospitalized participants enrolled in a smoking cessation randomized controlled trial (RCT). The study used baseline data from the RCT to explore frequencies of counselors' and smokers' behaviors among smokers who had reported more (vs. fewer) symptoms of depression (PHQ8 ≥ 10) or anxiety (GAD7 ≥ 10) at study entry. RESULTS: Participants (n = 37) were mostly female (23/37), White (26/37), with a median age of 58. At study entry while hospitalized, moderate-to-severe symptoms of depression (18/37) and anxiety (22/37) were common. Participant-led engagement behaviors included referencing past quit attempts, asking questions, elaborating response to yes/no questions, expressing commitment to behavior change, and assigning importance to nonautomated calls. Counselor-led behaviors included building off prior interaction, empathy, normalizing challenges, reframing and summarizing, validating achievements, and expressing shared experience. Both participants and counselors engaged via general discussion and humor. Participant-led engagement behaviors appeared more often in call transcripts among patients with higher baseline depression and anxiety symptoms compared to those with lower symptom scores. CONCLUSIONS: This study classified participant-led, counselor-led, and shared engagement behaviors during tobacco cessation counseling calls. Increased engagement via telephone counseling may be important for individuals with psychiatric symptoms identified at the start of treatment.

Cigarette Smoking and Risk Perceptions During the COVID-19 Pandemic Reported by Recently Hospitalized Participants in a Smoking Cessation Trial.

BACKGROUND: Cigarette smoking is a risk factor for severe COVID-19 disease. Understanding smokers' responses to the pandemic will help assess its public health impact and inform future public health and provider messages to smokers. OBJECTIVE: To assess risk perceptions and change in tobacco use among current and former smokers during the COVID-19 pandemic. DESIGN: Cross-sectional survey conducted in May-July 2020 (55% response rate) PARTICIPANTS: 694 current and former daily smokers (mean age 53, 40% male, 78% white) who had been hospitalized pre-COVID-19 and enrolled into a smoking cessation clinical trial at hospitals in Massachusetts, Pennsylvania, and Tennessee. MAIN MEASURES: Perceived risk of COVID-19 due to tobacco use; changes in tobacco consumption and interest in quitting tobacco use; self-reported quitting and relapse since January 2020. KEY RESULTS: 68% (95% CI, 65-72%) of respondents believed that smoking increases the risk of contracting COVID-19 or having a more severe case. In adjusted analyses, perceived risk was higher in Massachusetts where COVID-19 had already surged than in Pennsylvania and Tennessee which were pre-surge during survey administration (AOR 1.56, 95% CI, 1.07-2.28). Higher perceived COVID-19 risk was associated with increased interest in quitting smoking (AOR 1.72, 95% CI 1.01-2.92). During the pandemic, 32% (95% CI, 27-37%) of smokers increased, 37% (95% CI, 33-42%) decreased, and 31% (95% CI, 26-35%) did not change their cigarette consumption. Increased smoking was associated with higher perceived stress (AOR 1.49, 95% CI 1.16-1.91). Overall, 11% (95% CI, 8-14%) of respondents who smoked in January 2020 (pre-COVID-19) had quit smoking at survey (mean, 6 months later) while 28% (95% CI, 22-34%) of former smokers relapsed. Higher perceived COVID-19 risk was associated with higher odds of quitting and lower odds of relapse. CONCLUSIONS: Most smokers believed that smoking increased COVID-19 risk. Smokers' responses to the pandemic varied, with increased smoking related to stress and increased quitting associated with perceived COVID-19 vulnerability.

A Qualitative Study of the Impact of COVID-19 on Smoking Behavior for Participants in a Post-Hospitalization Smoking Cessation Trial.

(1) Background: COVID-19 has substantially altered individual environments and behaviors. We aim to explore the impact of COVID-19 on the smoking behavior of individuals trying to quit tobacco. (2) Methods: This study presents a qualitative analysis of individual interviews focused on perceived impacts of the COVID-19 pandemic on tobacco use among 39 participants in the Helping HAND 4 (HH4) post-hospitalization smoking cessation trial (NCT03603496). (3) Results: Emergent impacts of COVID-19 included change in routine, isolation, employment changes, and financial challenges; these in turn were associated with boredom, altered cravings and triggers, and increased stress. The availability of effective coping mechanisms instead of smoking to deal with stress heavily influenced subsequent smoking behavior. These results were triangulated with the Transactional Model of Stress, providing a framework to elucidate connections between factors such as perceived control, self-efficacy, and dispositional coping style, and highlighting potential areas for intervention. (4) Conclusions: Results suggest that stress during the COVID-19 pandemic may undermine effective coping skills among individuals enrolled in a post-hospitalization smoking cessation trial. Strengthening effective coping skills (e.g., minimizing the use of tobacco as a default stress response) and increasing perceived control and self-efficacy are promising intervention targets.

Enhancing employer coverage of smoking cessation treatment: A randomized trial of the Partners in Helping You Quit (PiHQ) program.

The workplace is a key channel for delivering tobacco cessation treatment to a population. Employers can provide workplace-based programs and/or financial incentives such as health insurance benefits that cover the cost of treatment accessed outside the workplace. Little is known about the effect of combining these strategies. We tested the benefit of adding a workplace cessation program, Partners in Helping You Quit (PiHQ), to comprehensive health insurance coverage of smoking cessation medications by Partners HealthCare, a large Boston-based healthcare delivery system. PiHQ offers biweekly telephone-based behavioral support, additional automated calls, and medication care coordination for 3 months then monthly telephone monitoring for 9 months. In a pragmatic randomized trial, employees who smoked were informed about the insurance benefit, then randomly assigned (2:1) to PiHQ or to active referral to a free 3-month phone-based community program, Massachusetts Quitline (QL). Outcomes were assessed at 3, 6, and 12 months. During 2015-2018, 106 smokers (n = 73 PiHQ, n = 33 QL) enrolled (64% female; 75% white, 21% black; mean age 46 years, mean cigarettes/day = 13). More PiHQ than QL participants made a quit attempt by 3 months (82 vs. 61%, p < .02) and achieved the primary outcome, verified past 7-day cigarette abstinence at 6 months (31 vs. 12%, odds ratio 3.34, 95% CI, 1.05-10.60). Among participants using behavioral support, PiHQ participants completed more scheduled calls and rated counseling helpfulness higher than did QL participants. These results suggest that employers can enhance the impact of providing comprehensive health insurance coverage of smoking cessation medication by adding a phone-based worksite cessation program.

Correction to: Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial.

An amendment to this paper has been published and can be accessed via the original article.

Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial.

BACKGROUND: Tobacco smoking remains the leading preventable cause of death in the US. A hospital admission provides smokers with a unique opportunity to stop smoking because it requires temporary tobacco abstinence while illness may enhance motivation to quit. Hospital interventions must continue post-discharge to increase tobacco abstinence long-term, but how best to accomplish this remains unclear. Building on two previous randomized controlled trials, each of which tested smoking cessation interventions that began in hospital and continued after discharge, this trial compares two interventions that provide sustained smoking cessation treatment after hospital discharge with the goal of improving long-term smoking cessation rates among hospitalized smokers. METHODS/DESIGN: Helping HAND 4 is a three-site randomized controlled trial that compares the effectiveness of two active interventions for producing validated past 7-day tobacco abstinence 6 months after hospital discharge. Smokers who are admitted to three hospitals receive a standard in-hospital smoking intervention, and those who plan to quit smoking after discharge are recruited and randomly assigned to two interventions that begin at discharge, Personalized Tobacco Care Management (PTCM) or Quitline eReferral. Each lasts 3 months. At discharge, PTCM provides 8 weeks of free nicotine replacement (NRT; a participant's choice of patch, gum, lozenge, or a combination) and then proactive smoking cessation support using an automated communication platform and live contact with a tobacco treatment specialist who is based in the health care system. In the eReferral condition, a direct referral is made from the hospital electronic health record to a community-based resource, the state's telephone quitline. The quitline provides up to 8 weeks of free NRT and offers behavioral support via a series of phone calls from a trained coach. Outcomes are assessed at 1, 3, and 6 months after discharge. The study hypothesis is that PTCM will produce higher quit rates than eReferral. DISCUSSION: Helping HAND 4 is a pragmatic trial that aims to evaluate interventions in real-world conditions. This project will give hospital systems critical evidence-based tools for meeting National Hospital Quality Measures for tobacco treatment and maximizing their ability to improve cessation rates and overall health for the millions of smokers hospitalized annually in the US. TRIAL REGISTRATION: Prospectively registered prior to start of enrollment at Clinicaltrials.gov, NCT03603496 (July 27, 2018). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00084MJ&selectaction=Edit&uid=U00002G7&ts=2&cx=ff0oxn.

Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network.

BACKGROUND: Population-based strategies can expand the reach of tobacco cessation treatment beyond clinical encounters. OBJECTIVE: To determine the effect of two population-based tobacco cessation strategies, compared with usual care, on providing tobacco treatment outside of clinical encounters. DESIGN: 3-arm pragmatic randomized controlled trial. PARTICIPANTS: Current smokers ≥ 18 years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n = 5225) and recruited using automated phone calls. INTERVENTIONS: One intervention group involved engagement with a health system-based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral). MEASUREMENTS: Proportion of smokers with documentation of any evidence-based cessation treatment in the 6 months after enrollment. KEY RESULTS: Of 639 individuals who responded to the proactive treatment offer, 233 consented and were randomized 1:1:1 to study arm. At 6-month follow-up, the pooled intervention group, compared with usual care, had higher documentation of any smoking cessation treatment (63% vs. 34%, p < 0.001), cessation medication prescription (52% vs. 30%, p = 0.002), and counseling (47% vs. 9%, p < 0.001). Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources. CONCLUSIONS: Smokers responding to a population-based, proactive outreach strategy had better provision of tobacco cessation treatment when referred to either a health system-based or community-based program compared with usual care. The health system-based strategy outperformed the quitline-based one in several measures. Future work should aim to improve population reach and test the effect on smoking cessation rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT03612895.

Feasibility of a proactive text messaging intervention for smokers in community health centers.

Introduction: Few smokers receive evidence-based cessation services during primary care visits. We aimed to assess the feasibility of a proactive text messaging program for primary care patients who smoke. Methods: We used electronic health records (EHRs) to identify smokers from two Massachusetts community health centers who had a mobile phone number listed. In March 2014-June 2015 patients were screened by their primary care physician then sent a proactive text message inviting them to enroll by texting back. Patients who opted-in were asked about their readiness to quit. The text message program included messages from the QuitNowTXT library and novel content for smokers who were not ready to quit. Results: Among 949 eligible smokers, 88 (9%) enrolled after receiving a single proactive text message. Compared with those who did not enroll, enrollees were more often female (61% vs. 48%, p=0.02) but otherwise did not differ in age, race, insurance status, or comorbidities. Twenty-eight percent of enrollees were not ready to quit in the next 30 days. The median time in the program was 9 days (interquartile range 2-32). Twenty-five percent of current smokers sent one or more keyword requests to the server. These did not differ by readiness to quit. Conclusions: A proactively delivered text messaging program targeting primary care patients who smoke was feasible and engaged both smokers ready to quit and those not ready to quit. This method shows promise as part of a population health model for addressing tobacco use outside of the primary care office.

Association of E-Cigarette Use With Smoking Cessation Among Smokers Who Plan to Quit After a Hospitalization: A Prospective Study.

Background: Many smokers report using e-cigarettes to help them quit smoking, but whether e-cigarettes aid cessation efforts is uncertain. Objective: To determine whether e-cigarette use after hospital discharge is associated with subsequent tobacco abstinence among smokers who plan to quit and are advised to use evidence-based treatment. Design: Secondary data analysis of a randomized controlled trial. (ClinicalTrials.gov: NCT01714323 [parent trial]). Setting: 3 hospitals. Participants: 1357 hospitalized adult cigarette smokers who planned to stop smoking, received tobacco cessation counseling in the hospital, and were randomly assigned at discharge to a tobacco treatment recommendation (control) or free tobacco treatment (intervention). Measurements: Self-reported e-cigarette use (exposure) was assessed 1 and 3 months after discharge; biochemically validated tobacco abstinence (outcome) was assessed 6 months after discharge. Results: Twenty-eight percent of participants used an e-cigarette within 3 months after discharge. In an analysis of 237 propensity score-matched pairs, e-cigarette users were less likely than nonusers to abstain from tobacco use at 6 months (10.1% vs. 26.6%; risk difference, -16.5% [95% CI, -23.3% to -9.6%]). The association between e-cigarette use and quitting varied between intervention patients, who were given easy access to conventional treatment (7.7% vs. 29.8%; risk difference, -22.1% [CI, -32.3% to -11.9%]), and control patients, who received only treatment recommendations (12.0% vs. 24.1%; risk difference, -12.0% [CI, -21.2% to 2.9%]) (P for interaction = 0.143). Limitations: Patients self-selected e-cigarette use. Unmeasured confounding is possible in an observational study. Conclusion: During 3 months after hospital discharge, more than a quarter of smokers attempting to quit used e-cigarettes, mostly to aid cessation, but few used them regularly. This pattern of use was associated with less tobacco abstinence at 6 months than among smokers who did not use e-cigarettes. Additional study is needed to determine whether regular use of e-cigarettes aids or hinders smoking cessation. Primary Funding Source: National Heart, Lung, and Blood Institute.

Examining the effects of illicit drug use on tobacco cessation outcomes in the Helping HAND 2 randomized controlled trial.

BACKGROUND: Individuals with substance use disorders (SUD) smoke at higher rates and have higher tobacco-related mortality than the general population. Despite having an interest in smoking cessation, smokers with SUDs may have greater difficulty quitting. METHODS: Analysis of data from a RCT testing a post-discharge smoking cessation intervention for hospitalized cigarette smokers interested in quitting. Past 7day tobacco abstinence was self-reported at 1, 3, and 6 months and biochemically confirmed at 6 months post-discharge. Other drug use was assessed at baseline by self-report or a past-year discharge diagnosis of SUD. Multiple logistic regression compared tobacco cessation outcomes among participants with no recreational drug use (NDU; n=942) vs. marijuana only (MU; n=284) vs. other illicit drugs (IDU; n=131). RESULTS: Groups differed at baseline on age, gender, race, education, other household smokers, alcohol use, and anxiety/depression (all p<0.05). Confirmed 6-month tobacco abstinence was lower among IDU than NDU participants (9% vs 18%, p=0.01; AOR=0.43, CI: 0.22-0.84) after adjustment for study arm, smoking characteristics, demographics, quality of life, alcohol use and MU. Confirmed 6-month abstinence did not differ significantly between MU vs. NDU participants (14% vs 18%, p>0.05; AOR=0.77, CI:0.51-1.14). Counseling and medication use did not differ significantly among groups at any follow-up. CONCLUSIONS: Hospitalized smokers who planned to stop smoking after discharge and used cessation assistance were less successful if they had used illicit drugs in the past year, but not if they had only used marijuana. More intensive or tailored interventions may be required to address smoking in this population.

Interactive Voice Response Calls to Promote Smoking Cessation after Hospital Discharge: Pooled Analysis of Two Randomized Clinical Trials.

BACKGROUND: Hospitalization offers smokers an opportunity to quit smoking. Starting cessation treatment in hospital is effective, but sustaining treatment after discharge is a challenge. Automated telephone calls with interactive voice response (IVR) technology could support treatment continuance after discharge. OBJECTIVE: To assess smokers' use of and satisfaction with an IVR-facilitated intervention and to test the relationship between intervention dose and smoking cessation. DESIGN: Analysis of pooled quantitative and qualitative data from the intervention groups of two similar randomized controlled trials with 6-month follow-up. PARTICIPANTS: A total of 878 smokers admitted to three hospitals. All received cessation counseling in hospital and planned to stop smoking after discharge. INTERVENTION: After discharge, participants received free cessation medication and five automated IVR calls over 3 months. Calls delivered messages promoting smoking cessation and medication adherence, offered medication refills, and triaged smokers to additional telephone counseling. MAIN MEASURES: Number of IVR calls answered, patient satisfaction, biochemically validated tobacco abstinence 6 months after discharge. KEY RESULTS: Participants answered a median of three of five IVR calls; 70% rated the calls as helpful, citing the social support, access to counseling and medication, and reminders to quit as positive factors. Older smokers (OR 1.36, 95% CI 1.20-1.54 per decade) and smokers hospitalized for a smoking-related disease (OR 1.65, 95% CI 1.21-2.23) completed more calls. Smokers who completed more calls had higher quit rates at 6-month follow-up (OR 1.49, 95% CI 1.30-1.70, for each additional call) after multivariable adjustment for age, sex, education, discharge diagnosis, nicotine dependence, duration of medication use, and perceived importance of and confidence in quitting. CONCLUSIONS: Automated IVR calls to support smoking cessation after hospital discharge were viewed favorably by patients. Higher IVR utilization was associated with higher odds of tobacco abstinence at 6-month follow-up. IVR technology offers health care systems a potentially scalable means of sustaining tobacco cessation interventions after hospital discharge. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifiers NCT01177176, NCT01714323.

A Post-Discharge Smoking-Cessation Intervention for Hospital Patients: Helping Hand 2 Randomized Clinical Trial.

INTRODUCTION: Hospitalization provides an opportunity for smokers to quit, but tobacco-cessation interventions started in hospital must continue after discharge to be effective. This study aimed to improve the scalability of a proven effective post-discharge intervention by incorporating referral to a telephone quitline, a nationally available cessation resource. STUDY DESIGN: A three-site RCT compared Sustained Care, a post-discharge tobacco-cessation intervention, with Standard Care among hospitalized adult smokers who wanted to quit smoking and received in-hospital tobacco-cessation counseling. SETTING/PARTICIPANTS: A total of 1,357 daily smokers admitted to three hospitals were enrolled from December 2012 to July 2014. INTERVENTION: Sustained Care started at discharge and included automated interactive voice response telephone calls and the patient's choice of cessation medication for 3 months. Each automated call advised cessation, supported medication adherence, and triaged smokers seeking additional counseling or medication support directly to a telephone quitline. Standard Care provided only medication and counseling recommendations at discharge. MAIN OUTCOME MEASURES: Biochemically confirmed past 7-day tobacco abstinence 6 months after discharge (primary outcome) and self-reported tobacco abstinence and tobacco-cessation treatment use at 1, 3, and 6 months and overall (0-6 months). Analyses were done in 2015-2016. RESULTS: Smokers offered Sustained Care (n=680), versus those offered Standard Care (n=677), did not have greater biochemically confirmed abstinence at 6 months (17% vs 16%, p=0.58). However, the Sustained Care group reported more tobacco-cessation counseling and medication use at each follow-up and higher rates of self-reported past 7-day tobacco abstinence at 1 month (43% vs 32%, p<0.0001) and 3 months (37% vs 30%, p=0.008). At 6 months, the difference narrowed (31% vs 27%, p=0.09). Overall, the intervention increased self-reported 7-day abstinence over the 6-month follow-up (relative risk, 1.25; 95% CI=1.10, 1.40; p=0.0006). CONCLUSIONS: A 3-month post-discharge smoking-cessation intervention for hospitalized smokers who wanted to quit did not increase confirmed tobacco abstinence at 6 months but did increase self-reported abstinence during the treatment period (3 months). Real-time linkage of interactive voice response calls to a quitline, done in this trial to increase scalability of a previously proven cessation intervention, demonstrated short-term promise but did not sustain long-term intervention effectiveness. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01714323.

Smoking Status Confirmation by Proxy: Validation in a Smoking Cessation Trial.

INTRODUCTION: Biochemical confirmation (BC) of self-report is the gold standard of evidence for abstinence in smoking cessation research, but difficulty in obtaining samples may bias estimates of quit rates. Proxy confirmation (PC) has not been validated in cessation trials. We assessed the feasibility and validity of PC in a cessation trial for hospitalized smokers. METHODS: We enrolled 402 daily cigarette smokers during a hospital admission. At enrollment, participants provided demographics, smoking history, and named proxies to confirm their smoking status at follow-up. Participants provided self-reported (SR) 7-day tobacco abstinence by telephone at 6 months post-discharge. SR quitters were asked to mail a saliva sample for BC. Incentives were offered for survey completion ($20) and returned samples ($50). We called proxies for all those with SR to obtain PC. Quit rates were calculated with missing data indicating smoking. We assessed associations of nonresponse with baseline characteristics using chi-squared tests and logistic regression. We calculated the sensitivity and specificity of PC in detecting smokers as determined by BC. RESULTS: All patients named at least one proxy. Response rates were 82% for SR, 84% for PC, and 69% for BC. Observed participant characteristics were unrelated to provision of sample for BC. Estimated quit rates were 35% for SR, 27% for SR + PC, 21% for SR + BC and 27% for SR + BC or PC. Sensitivity of PC was not higher than SR (73% vs. 77%); specificity was lower (84% vs. 100%). CONCLUSION: PC was feasible but not superior to self-report in a cessation trial.

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers: study protocol for the Helping HAND 2 randomized controlled trial.

BACKGROUND: Smoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation, but only if the tobacco dependence treatment continues after the patient leaves the hospital. Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems. Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment, including both medication and counseling, after hospital discharge. We subsequently streamlined the intervention model to increase its potential for dissemination. This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers. This paper describes the trial design and contrasts it with the earlier study. METHODS/DESIGN: A 2-arm, 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge. The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania. Participants receive the same smoking cessation intervention in the hospital. They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge. Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages, medication refills, and access to a live tobacco treatment counselor. Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources. Outcomes are assessed at 1, 3, and 6 months after discharge. The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6-month follow-up. Other outcome measures include self-reported tobacco abstinence measures, use of medication and counseling after discharge, hospital readmissions, and program cost-effectiveness. DISCUSSION: We adapted a proven intervention for hospitalized smokers to enhance its potential for dissemination and are testing it in a multi-site trial. Study enrollment data suggests that the trial achieved the goal of recruiting a broader sample of hospitalized smokers. TRIAL REGISTRATION: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2) NCT01714323. Registered October 22, 2012.

Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial.

IMPORTANCE: Health care systems need effective models to manage chronic diseases like tobacco dependence across transitions in care. Hospitalizations provide opportunities for smokers to quit, but research suggests that hospital-delivered interventions are effective only if treatment continues after discharge. OBJECTIVE: To determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial compared sustained care (a postdischarge tobacco cessation intervention) with standard care among 397 hospitalized daily smokers (mean age, 53 years; 48% were males; 81% were non-Hispanic whites) who wanted to quit smoking after discharge and received a tobacco dependence intervention in the hospital; 92% of eligible patients and 44% of screened patients enrolled. The study was conducted from August 2010 through November 2012 at Massachusetts General Hospital. INTERVENTIONS: Sustained care participants received automated interactive voice response telephone calls and their choice of free smoking cessation medication (any type approved by the US Food and Drug Administration) for up to 90 days. The automated telephone calls promoted cessation, provided medication management, and triaged smokers for additional counseling. Standard care participants received recommendations for postdischarge pharmacotherapy and counseling. MAIN OUTCOMES AND MEASURES: The primary outcome was biochemically confirmed past 7-day tobacco abstinence at 6-month follow-up after discharge from the hospital; secondary outcomes included self-reported tobacco abstinence. RESULTS: Smokers randomly assigned to sustained care (n = 198) used more counseling and more pharmacotherapy at each follow-up assessment than those assigned to standard care (n = 199). Biochemically validated 7-day tobacco abstinence at 6 months was higher with sustained care (26%) than with standard care (15%) (relative risk [RR], 1.71 [95% CI, 1.14-2.56], P = .009; number needed to treat, 9.4 [95% CI, 5.4-35.5]). Using multiple imputation for missing outcomes, the RR for 7-day tobacco abstinence was 1.55 (95% CI, 1.03-2.21; P = .04). Sustained care also resulted in higher self-reported continuous abstinence rates for 6 months after discharge (27% vs 16% for standard care; RR, 1.70 [95% CI, 1.15-2.51]; P = .007). CONCLUSIONS AND RELEVANCE: Among hospitalized adult smokers who wanted to quit smoking, a postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at 6 months compared with a standard recommendation to use counseling and medication after discharge. These findings, if replicated, suggest an approach to help achieve sustained smoking cessation after a hospital stay. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01177176.

Healthcare system effects of pay-for-performance for smoking status documentation.

OBJECTIVES: To evaluate the impact on smoking status documentation of a payer-sponsored pay-for-performance (P4P) incentive that targeted a minority of an integrated healthcare delivery system's patients. STUDY DESIGN: Three commercial insurers simultaneously adopted P4P incentives to document smoking status of their members with 3 chronic diseases. The healthcare system responded by adding a smoking status reminder to all patients' electronic health records (EHRs). We measured change in smoking status documentation before (2008-2009) and after (2010-2011) P4P implementation by patient P4P eligibility. METHODS: The P4P-eligible patients were compared primarily with a subset of non-P4P-eligible patients who resembled P4P-eligible patients and also with all non-P4P-eligible patients. Multivariate models adjusted for patient and provider characteristics and accounted for provider-level clustering and preimplementation trends. RESULTS: Documentation increased from 48% of 207,471 patients before P4P to 71% of 227,574 patients after P4P. Improvement from 56% to 83% occurred among P4P-eligible patients (adjusted odds ratio [AOR], 3.6; 95% confidence interval [CI], 2.9-4.5) and from 56% to 80% among the comparable subset of non-P4P-eligible patients (AOR, 3.0; 95% CI, 2.3-3.9). The difference in improvement between groups was significant (AOR, 1.3; 95% CI, 1.1-1.4; P = .009). CONCLUSIONS: A P4P incentive targeting a minority of a healthcare system's patients stimulated adoption of a system wide EHR reminder and improved smoking status documentation overall. Combining a P4P incentive with an EHR reminder might help healthcare systems improve treatment delivery for smokers and meet "meaningful use" standards for EHRs.

Implementation of an electronic health record-based care management system to improve tobacco treatment.

BACKGROUND: Tobacco treatment is underused in primary care. We designed a Tobacco Care Management system to increase the delivery of treatment and reduce the burden on primary care providers (PCPs). A one-click functionality added to the electronic health record (EHR) allowed PCPs to refer smokers to a centralized tobacco treatment coordinator (TTC) who called smokers, provided brief counseling, connected them to ongoing treatment and gave feedback to PCPs. OBJECTIVE: To study the system's feasibility and acceptability among PCPs, and its utilization by smokers. DESIGN: Using a mixed methods design, we documented system utilization quantitatively from February 1, 2010 to July 31, 2011, and conducted two focus groups with PCPs in June 2011. PARTICIPANTS: Thirty-six PCPs and 2,894 smokers from two community health centers in Massachusetts. MAIN MEASURES: Quantitative: One-click referral utilization by PCPs, proportion of smokers referred and connected to treatment. Qualitative: PCPs' reasons for use, barriers to use, and experiences with feedback. KEY RESULTS: Twenty-nine PCPs (81 %) used the functionality more than once, generating 466 referrals for 15 % of known smokers seen during the study. The TTC reached 260 (56 %) of the referrals and connected 135 (29 %) to additional treatment. The director of one center sent PCPs monthly feedback about their utilization compared to peers. These PCPs referred a greater proportion of their known smokers (18 % vs. 9 %, p<0.0001) and reported that monthly feedback motivated referrals. PCPs attending focus groups (n=24) appreciated the system's simplicity, access to updated resources, and time-efficient way to address smoking, and wanted more feedback about cessation outcomes. They collectively supported the system's continuation. CONCLUSIONS: A novel EHR-based Tobacco Care Management system was adopted by PCPs, especially those receiving performance feedback, and connected one-third of referred smokers to treatment. The model has the potential to improve the delivery and outcomes of evidence-based tobacco treatment in primary care.

Clinician characteristics and use of novel electronic health record functionality in primary care.

BACKGROUND: Conventional wisdom holds that older, busier clinicians who see complex patients are less likely to adopt and use novel electronic health record (EHR) functionality. METHODS: To compare the characteristics of clinicians who did and did not use novel EHR functionality, we conducted a retrospective analysis of the intervention arm of a randomized trial of new EHR-based tobacco treatment functionality. RESULTS: The novel functionality was used by 103 of 207 (50%) clinicians. Staff physicians were more likely than trainees to use the functionality (64% vs 37%; p<0.001). Clinicians who graduated more than 10 years previously were more likely to use the functionality than those who graduated less than 10 years previously (64% vs 42%; p<0.01). Clinicians with higher patient volumes were more likely to use the functionality (lowest quartile of number of patient visits, 25%; 2nd quartile, 38%; 3rd quartile, 65%; highest quartile, 71%; p<0.001). Clinicians who saw patients with more documented problems were more likely to use the functionality (lowest tertile of documented patient problems, 38%; 2nd tertile, 58%; highest tertile, 54%; p=0.04). In multivariable modeling, independent predictors of use were the number of patient visits (OR 1.2 per 100 additional patients; 95% CI 1.1 to 1.4) and number of documented problems (OR 2.9 per average additional problem; 95% CI 1.4 to 6.1). CONCLUSIONS: Contrary to conventional wisdom, clinically busier physicians seeing patients with more documented problems were more likely to use novel EHR functionality.

An electronic health record-based intervention to improve tobacco treatment in primary care: a cluster-randomized controlled trial.

BACKGROUND: To improve the documentation and treatment of tobacco use in primary care, we developed and implemented a 3-part electronic health record enhancement: (1)smoking status icons, (2) tobacco treatment reminders, and (3) a Tobacco Smart Form that facilitated the ordering of medication and fax and e-mail counseling referrals. METHODS: We performed a cluster-randomized controlled trial of the enhancement in 26 primary care practices between December 19, 2006, and September 30, 2007. The primary outcome was the proportion of documented smokers who made contact with a smoking cessation counselor. Secondary outcomes included coded smoking status documentation and medication prescribing. RESULTS: During the 9-month study period, 132 630 patients made 315 962 visits to study practices. Coded documentation of smoking status increased from 37% of patients to 54% (+17%) in intervention practices and from 35% of patients to 46% (+11%) in control practices (P < .001 for the difference in differences). Among the 9589 patients who were documented smokers at the start of the study, more patients in the intervention practices were recorded as nonsmokers by the end of the study (5.3% vs 1.9% in control practices; P < .001). Among 12 207 documented smokers, more patients in the intervention practices made contact with a cessation counselor (3.9% vs 0.3% in control practices; P < .001). Smokers in the intervention practices were no more likely to be prescribed smoking cessation medication (2% vs 2% in control practices; P = .40). CONCLUSION: This electronic health record-based intervention improved smoking status documentation and increased counseling assistance to smokers but not the prescription of cessation medication.