A Post-Discharge Smoking-Cessation Intervention for Hospital Patients: Helping Hand 2 Randomized Clinical Trial.
ABSTRACT: 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.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.A total of 1,357 daily smokers admitted to three hospitals were enrolled from December 2012 to July 2014.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.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.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).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.This study is registered at www.clinicaltrials.gov NCT01714323.
Project description: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.
Project description: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.To determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care.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.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.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.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).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.clinicaltrials.gov Identifier: NCT01177176.
Project description: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.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.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.Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2) NCT01714323. Registered October 22, 2012.
Project description:Few hospitals treat patients' tobacco dependence. To be effective, hospital-initiated cessation interventions must provide at least 1 month of supportive contact post-discharge.Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014-June 2015.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.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.Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness.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).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.
Project description: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.
Project description:A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care.A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit.This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs.United States Clinical Trials Registry NCT01177176.
Project description:BACKGROUND:Smokers usually abstain from tobacco while hospitalized but relapse after discharge. Inpatient interventions may encourage sustained quitting. We previously demonstrated that a decision support tool embedded in an electronic health record (EHR) improved physicians' treatment of hospitalized smokers. This report describes the effect on quit rates of this decision support tool and order set for hospitalized smokers. METHODS:In a single hospital system, 254 physicians were randomized 1:1 to receive a decision support tool and order set, embedded in the EHR. When an adult patient was admitted to a medical service, an electronic alert appeared if current smoking was recorded in the EHR. For physicians receiving the intervention, the alert linked to an order set for tobacco treatment medications and electronic referral to the state tobacco quitline. Additionally, "Tobacco Use Disorder" was added to the patient's problem list, and a secure message was sent to the patient's primary care provider (PCP). In the control arm, no alert appeared. Patients were contacted by phone at 1, 6, and 12?months; those reporting tobacco abstinence at 12?months were asked to return to measure exhaled carbon monoxide. Generalized estimating equations were used to model the data. RESULTS:From 2013 to 2016, the alert fired for 10,939 patients (5391 intervention, 5548 control). Compared to control physicians, intervention physicians were more likely to order tobacco treatment medication, populate the problem list with tobacco use disorder, refer to the quitline, and notify the patient's PCP. In a subset of 1044 patients recruited for intensive follow-up, one-year quit rates for intervention and control patients were, respectively, 11.5% and 11.6%, (p?=?0.94), after controlling for age, sex, race, ethnicity, and insurance. Similarly, there were no differences in 1- and 6-month quit rates. CONCLUSIONS:Although we were able to improve processes of care, long-term tobacco quit rates were unchanged. This likely reflects, in part, the need for sustained quitting interventions, and higher-than-expected quit rates in controls. Future enhancements should improve prescription of medications for smoking cessation at discharge, engagement of primary care providers, and perhaps direct engagement of patients in a more longitudinal approach. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01691105 . Registered on September 12, 2012.
Project description: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.
Project description:Quitlines provide evidence-based tobacco treatment and multiple calls yield higher quit rates. This study aimed to identify subgroups of smokers with greater quitline engagement following referral during hospitalization. Data were from a randomized clinical trial assessing the effectiveness of fax referral (referral faxed to proactive quitline) versus warm handoff (patient connected to quitline at bedside) (n?=?1054). Classification and regression trees analyses evaluated individual and treatment/health system-related variables and their interactions. Among all participants, warm handoff, higher ratings of the tobacco treatment care transition, and being older predicted completing more quitline calls. Among patients enrolled in the quitline, higher transition of care ratings, being older, and use of cessation medication post-discharge predicted completing more calls. Three of the four factors influencing engagement were characteristics of treatment within the hospital (quality of tobacco treatment care transition and referral method) and therapy (use of cessation medications), suggesting potential targets to increase quitline engagement post-discharge.
Project description:Tobacco dependence treatment for hospitalized smokers results in long-term cessation if treatment continues at least 30 days post-discharge. Health information technology may facilitate ongoing tobacco dependence treatment after hospital discharge. To describe the use and impact of a new decision support tool and order set for inpatient physicians, addressing tobacco dependence treatment for hospitalized smokers, embedded in an electronic health record (EHR). In a cluster-randomized trial, 254 physicians were randomized (1:1) to either receive or not receive the decision support tool and order set, which were embedded in the Epic (Madison, WI) EHR used at 2 hospitals in a single city. When an adult patient was admitted to a medical service, an electronic alert appeared if the patient was coded in the EHR as a smoker. For physicians randomized to the intervention, the alert linked to an order set to prescribe tobacco treatment medications and refer the patient to the state tobacco quitline. Additionally, "tobacco use disorder" was added to the patient's problem list, and an e-mail was sent to the patient's primary care provider (PCP). In the control arm, an alert fired with no screen visibility. Generalized estimating equations were used to model the data. Since August 2013, the alert has appeared for 10,939 patients (5391 intervention, 5548 control). Compared to control physicians, intervention physicians were more likely to order tobacco treatment medication (35 vs. 29%, P < 0.0001), populate the problem list with tobacco use disorder (41 vs. 2%, P < 0.0001), and make a referral to the state smokers' quitline (30 vs. 0%, P < 0.0001). In addition, intervention physicians sent an e-mail to the patient's PCP 4152 (99%) times. Designing and implementing an order set and alert for tobacco treatment in an EHR is feasible and helps physicians place more orders for tobacco treatment medication, referrals to the state smokers' quitline, and e-mails to patients' PCPs. Data on cessation outcomes are pending.www.ClinicalTrials.gov (NCT01691105).