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

ABSTRACT: 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.

SUBMITTER: Rigotti NA

PROVIDER: S-EPMC7164139 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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

Rigotti Nancy A NA Schnitzer Kristina K Davis Esa M EM Regan Susan S Chang Yuchiao Y Kelley Jennifer H K JHK Notier Anna E AE Gilliam Karen K Douaihy Antoine A Levy Douglas E DE Singer Daniel E DE Tindle Hilary A HA

Trials 20200416 1

<h4>Background</h4>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 cessa ...[more]

PMID: 32299470

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Project description:BackgroundSmoking 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/designA 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.DiscussionWe 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 registrationComparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2) NCT01714323. Registered October 22, 2012.

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: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:Most smokers abstain from smoking during hospitalization but relapse upon discharge. This study tests the effectiveness of two proven treatments (i.e., nicotine patches and telephone counseling) in helping these patients stay quit after discharge from the hospital, and assesses a model of hospital-quitline partnership.This study had a 2×2 factorial design in which participants were stratified by recruitment site and smoking rate and randomly assigned to usual care, nicotine patches only, counseling only, or patches plus counseling. They were evaluated at 2 and 6 months post-randomization.A total of 1,270 hospitalized adult smokers were recruited from August 2011 to November 2013 from five hospitals within three healthcare systems.Participants in the patch condition were provided 8 weeks of nicotine patches at discharge (or were mailed them post-discharge). Quitline staff started proactively calling participants in the counseling condition 3 days post-discharge to provide standard quitline counseling.The primary outcome measure was self-reported 30-day abstinence at 6 months using an intention-to-treat analysis. Data were analyzed from September 2015 to May 2016.The 30-day abstinence rate at 6 months was 22.8% for the nicotine patch condition and 18.3% for the no-patch condition (p=0.051). Nearly all participants (99%) in the patch condition were provided nicotine patches, although 36% were sent post-discharge. The abstinence rates were 20.0% and 21.1% for counseling and no counseling conditions, respectively (p=0.651). Fewer than half of the participants in the counseling condition (47%) received counseling (mean follow-up sessions, 3.6).Provision of nicotine patches proved feasible, although their effectiveness in helping discharged patients stay quit was not significant. Telephone counseling was not effective, in large part because of low rates of engagement. Future interventions will need to be more immediate to be effective.This study is registered at www.clinicaltrials.gov NCT01289275.

Project description:ImportanceSmoking 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.ObjectiveTo 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 participantsThis 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.InterventionsTTCM 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 measuresThe 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.ResultsA 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 relevanceIn 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 registrationClinicalTrials.gov Identifier: NCT03603496.

Project description: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.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.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.Clinical Trials Registration NCT01305928.

Project description:OBJECTIVE:Text messaging interventions are effective. Despite high utilization of smartphones, few studies evaluate text messaging for cessation in middle-/lower-income countries. Initiating tobacco treatment in hospitals is an effective but underutilized approach for reaching smokers. We evaluated a hybrid phone counseling/text messaging intervention for supporting cessation among hospitalized smokers in Brazil. METHODS:We used an experimental design to assess the feasibility and potential effect size of the intervention. Participants (N = 66) were recruited from a university hospital and randomized in a 2:1 ratio into TXT (one session of telephone counseling plus 2 weeks of text messaging; N = 44) or Standard Care control group (N = 22). Participants lost to follow-up were counted as smokers. RESULTS:Counselors sent 1186 texts, of which 924 (77.9%) were received by study participants. Participants rated the TXT content as "helpful" (80.4%) and the phone counseling length to be "just right" (95.1%). Although the study was not powered to evaluate abstinence rates, we did observe a higher prevalence of abstinence in the TXT compared to control group at both 1-month follow-up (25.0% vs. 9.1%) and 3-month follow-up (31.8% vs. 9.1%). Carbon monoxide-verified abstinence at month 3 was also higher in TXT (20.5% vs. 4.5%). CONCLUSIONS:This hybrid telephone/text intervention should progress to full-scale effectiveness testing as it achieved favorable outcomes, was acceptable to participants, and was readily implemented. This type of intervention has strong potential for expanding the reach of hospital-initiated tobacco treatment in middle-/lower-income countries. IMPLICATIONS:This study extends research on hospital-initiated smoking cessation by establishing the feasibility of a novel text-messaging approach for post-discharge follow-up. Text messaging is a low-cost alternative to proactive telephone counseling that could help overcome resource barriers in middle- and lower-income countries. This hybrid texting/counseling intervention identified smokers in hospitals, established rapport through a single telephone follow-up, and expanded acceptability and reach of later support by using text-messaging, which is free of charge in this and other low-income countries. The favorable cessation outcomes achieved by the hybrid intervention provide support for a fully powered effectiveness trial.

Dataset Information

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

Publications

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

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