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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.

SUBMITTER: Rigotti NA

PROVIDER: S-EPMC5031242 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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

Rigotti Nancy A NA Tindle Hilary A HA Regan Susan S Levy Douglas E DE Chang Yuchiao Y Carpenter Kelly M KM Park Elyse R ER Kelley Jennifer H K JH Streck Joanna M JM Reid Zachary Z ZZ Ylioja Thomas T Reyen Michele M Singer Daniel E DE

American journal of preventive medicine 20161001 4

<h4>Introduction</h4>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.<h4>Study design</h4>A three-site RCT compared Sustained Care, a post-discharge tobacco-cessation intervention, with Standard Ca ...[more]

PMID: 27647060

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Project description:BACKGROUND:Cessation counseling and pharmacotherapy are recommended for hospitalized smokers, but better coordination between cessation counselors and providers might improve utilization of pharmacotherapy and enhance smoking cessation. OBJECTIVE:To compare smoking cessation counseling combined with care coordination post-hospitalization to counseling alone on uptake of pharmacotherapy and smoking cessation. DESIGN:Unblinded, randomized clinical trial PARTICIPANTS: Hospitalized smokers referred from primarily rural hospitals INTERVENTIONS: Counseling only (C) consisted of telephone counseling provided during the hospitalization and post-discharge. Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker's health care team and help for the smoker in obtaining pharmacotherapy. At 6 months post-hospitalization, persistent smokers were re-engaged with either CCC or C. MAIN MEASURES:Utilization of pharmacotherapy and smoking cessation at 3, 6, and 12 months post-discharge. KEY RESULTS:Among 606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis. Use of any cessation pharmacotherapy between 0 and 6 months (55.2%) and between 6 and 12 months (47.1%) post-discharge was similar across treatment arms though use of prescription-only pharmacotherapy between months 6-12 was significantly higher in the CCC group (30.1%) compared with the C group (18.6%) (RR, 1.61 (95% CI, 1.08, 2.41)). Self-reported abstinence rates of 26.2%, 20.3%, and 23.4% at months 3, 6, and 12, respectively, were comparable across the two treatment arms. Of those smoking at month 6, 12.5% reported abstinence at month 12. Validated smoking cessation at 12 months was 19.3% versus 16.9% in the CCC and C groups, respectively (RR, 1.13 (95% CI, 0.80, 1.61)). CONCLUSION:Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone. Re-engagement of smokers 6 months post-discharge can lead to new quitters, at which time care coordination might facilitate use of prescription medications. TRIAL REGISTRATION:NCT01063972.

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: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:Hospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions.A randomized comparative effectiveness trial was conducted.At two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months.At discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814).Self-reported abstinence at 6 months was measured. Analyses were conducted in late 2015.One quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40).Intensive counseling was more effective than referral to the state quitline. Long-term abstinence was excellent in both groups. Many patients were not eligible for enrollment despite minimal exclusion criteria.This study is registered at www.clinicaltrials.gov NCT01363245.

Project description:BACKGROUND:China has the highest global prevalence of cigarette smokers, accounting for more than 40% of the total cigarette consumption in the world. Considering the shortage of smoking cessation services in China, and the acceptability, feasibility, and efficacy of mobile-phone-based text messaging interventions for quitting smoking in other countries, we conducted a mobile-phone-based smoking cessation study in China. METHODS AND FINDINGS:We conducted a randomized controlled trial in China across 30 cities and provinces from August 17, 2016, to May 27, 2017. Adult smokers aged 18 years and older with the intention to quit smoking were recruited and randomized to a 12-week high-frequency messaging (HFM) or low-frequency messaging (LFM) intervention ("Happy Quit") or to a control group in a 5:2:3 ratio. The control group received only text messages unrelated to quitting. The primary outcome was biochemically verified continuous smoking abstinence at 24 weeks. Secondary outcomes included (1) self-reported 7-day point prevalence of abstinence (i.e., not even a puff of smoke, for the last 7 days) at 1, 4, 8, 12, 16, 20, and 24 weeks; (2) self-reported continuous abstinence at 4, 12, and 24 weeks; and (3) self-reported average number of cigarettes smoked per day. A total of 1,369 participants received 12 weeks of intervention or control text messages with continued follow-up for 12 weeks. The baseline characteristics of participants among the HFM (n = 674), LFM (n = 284), and control (n = 411) groups were similar. The study sample included 1,295 (94.6%) men; participants had a mean age of 38.1 (SD 9.79) years and smoked an average of 20.1 (SD 9.19) cigarettes per day. We included the participants in an intention-to-treat analysis. Biochemically verified continuous smoking abstinence at 24 weeks occurred in 44/674 participants in the HFM group (6.5%), 17/284 participants in the LFM group (6.0%), and 8/411 participants (1.9%) in the control group; participants in both the HFM (odds ratio [OR] = 3.51, 95% CI 1.64-7.55, p < 0.001) and the LFM (OR = 3.21, 95% CI 1.36-7.54], p = 0.002) intervention groups were more likely to quit smoking than those in the control group. However, there was no difference in quit rate between the HFM and LFM interventions. We also found that the 7-day point quit rate from week 1 to week 24 ranged from approximately 10% to more than 26% with the intervention and from less than 4% to nearly 12% without the intervention. Those who continued as smokers in the HFM group smoked 1 to 3 fewer cigarettes per day than those in the LFM group over the 24 weeks of trial. Among study limitations, the participants were able to use other smoking cessation services (although very few participants reported using them), cotinine tests can only detect smoking status for a few days, and the proportion of quitters was small. CONCLUSIONS:Our findings demonstrate that a mobile-phone-based text messaging intervention (Happy Quit), with either high- or low-frequency messaging, led to smoking cessation in the present study, albeit in a low proportion of smokers, and can therefore be considered for use in large-scale intervention efforts in China. Mobile-phone-based interventions could be paired with other smoking cessation services for treatment-seeking smokers in China. TRIAL REGISTRATION:ClinicalTrials.gov NCT02693626.

Dataset Information

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

Publications

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

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