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Adaptation of a sustained care cessation intervention for smokers hospitalized for psychiatric disorders: Study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32?years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully quit smoking with adequate support. Further evidence shows that using technology to deliver sustained care interventions to hospitalized smokers can lead to smoking cessation up to 6?months after discharge. The current comparative effectiveness trial adapts a technology-assisted sustained care intervention designed for smokers admitted to a general hospital and tests whether this approach can produce higher cessation rates compared to usual care for smokers admitted to a psychiatric inpatient unit. METHODS:A total of 353 eligible patients hospitalized for psychiatric illness are randomized by cohort into one of two conditions, Sustained Care (SusC) or Usual Care (UC), and are followed for six months after discharge. Participants assigned to UC receive brief tobacco education delivered by a hospital nurse during or soon after admission. Those assigned to SusC receive a 40-min, in-hospital motivational counseling intervention. Upon discharge, they also receive up to 8?weeks of free nicotine patches, automated interactive voice response (IVR) telephone and text messaging, and access to cessation counseling resources lasting 3?months post discharge. Smoking cessation outcomes are measured at 1-, 3- and 6-months post hospital discharge. CONCLUSION:Results from this comparative effectiveness trial will add to our understanding of acceptable and effective smoking cessation approaches for patients hospitalized with SMI.

SUBMITTER: Hecht J

PROVIDER: S-EPMC7197194 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Adaptation of a sustained care cessation intervention for smokers hospitalized for psychiatric disorders: Study protocol for a randomized controlled trial.

Hecht Jacki J Rigotti Nancy A NA Minami Haruka H Kjome Kimberly L KL Bloom Erika L EL Kahler Christopher W CW Price Lawrence H LH Levy Douglas E DE Carpenter Kelly M KM Brown Richard A RA

Contemporary clinical trials 20190615

<h4>Background</h4>Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully quit smoking with adequate support. Further evidence shows that using technology to deliver sustained care interventions to hospitalized smokers can lead to smoking cessation ...[more]

PMID: 31212100

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Project description:ImportanceSmoking among individuals with serious mental illness (SMI) represents a major public health problem. Intervening during a psychiatric hospital stay may provide an opportunity to aid engagement in smoking cessation treatment and facilitate success in quitting.ObjectiveTo examine the effectiveness of a multicomponent, sustained care (SusC) smoking cessation intervention in adults with SMI receiving inpatient psychiatric care.Design, setting, and participantsThe Helping HAND 3 randomized clinical trial compared SusC with usual care (UC) among individuals with SMI who smoked daily and were receiving inpatient psychiatric care in Austin, Texas, in a single hospital. The study was conducted from July 2015 through August 2019.InterventionsThe UC intervention involved brief smoking cessation information, self-help materials and advice from the admitting nurse, and an offer to provide nicotine replacement therapy during hospitalization. The SusC intervention included 4 main components designed to facilitate patient engagement with postdischarge smoking cessation resources: (1) inpatient motivational counseling; (2) free transdermal nicotine patches on discharge; (3) an offer of free postdischarge telephone quitline, text-based, and/or web-based smoking cessation counseling, and (4) postdischarge automated interactive voice response calls or text messages.Main outcomes and measuresThe primary outcome was biochemically verified 7-day point-prevalence abstinence at 6-month follow-up. A secondary outcome was self-reported smoking cessation treatment use at 1, 3, and 6 months after discharge.ResultsA total of 353 participants were randomized, of whom 342 were included in analyses (mean [SD] age, 35.8 [12.3] years; 268 White individuals [78.4%]; 280 non-Hispanic individuals [81.9%]; 169 women [49.4%]). They reported smoking a mean (SD) of 16.9 (10.4) cigarettes per day. Participants in the SusC group evidenced significantly higher 6-month follow-up point-prevalence abstinence rates than those in the UC group (8.9% vs 3.5%; adjusted odds ratio, 2.95 [95% CI, 1.24-6.99]; P = .01). The number needed to treat was 18.5 (95% CI, 9.6-306.4). A series of sensitivity analyses confirmed effectiveness. Finally, participants in the SusC group were significantly more likely to report using smoking cessation treatment over the 6 months postdischarge compared with participants in the UC group (74.6% vs 40.5%; relative risk, 1.8 [95% CI, 1.51-2.25]; P < .001).Conclusions and relevanceThe findings of this randomized clinical trial provide evidence for the effectiveness of a scalable, multicomponent intervention in promoting smoking cessation treatment use and smoking abstinence in individuals with SMI following hospital discharge.Trial registrationClinicalTrials.gov Identifier: NCT02204956.

Project description:ImportanceHealth 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.ObjectiveTo determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care.Design, setting, and participantsA 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.InterventionsSustained 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 measuresThe 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.ResultsSmokers 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 relevanceAmong 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 registrationclinicaltrials.gov Identifier: NCT01177176.

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.

Project description:BackgroundApproximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.ObjectiveThis paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.MethodsA two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).ResultsRecruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).ConclusionsIf the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.International registered report identifier (irrid)RR1-10.2196/18071.

Project description:BackgroundChina is the largest tobacco producer and has the highest number of tobacco consumers in the world. Extensive research has demonstrated the utility of social media for smoking cessation. WeChat is the most commonly used social media platform in China, but has not yet been utilized for smoking cessation interventions. The objectives of this study are (1) to evaluate the efficacy of a WeChat-based smoking cessation intervention; and (2) to examine a possible additive effect of integrating oral health and smoking-related information into a tailored, Transtheoretical Model (TTM) guided smoking cessation intervention.MethodsEligible adults were recruited through WeChat from July 1 to August 6, 2019, to participate in a 3-arm, single-blinded, randomized controlled trial. We enrolled and randomized 403 participants into three groups: the Standard Group, Enhanced Group, or a Waitlist-Control Group. Participants in the Standard Group received 20 smoking cessation-related messages for 2 weeks; participants in the Enhanced Group received this same protocol plus 6 oral health-related messages over an additional week. Participants in the Control Group received smoking cessation-related messages, after the post-intervention assessment. The primary outcome was TTM Stage of Change, and the secondary outcomes were 7-day Point Prevalence Abstinence (PPA), 24-h PPA, daily cigarette use, and nicotine dependence at 4 weeks follow-up post intervention, comparing intervention groups with the control group. The overall program attrition rate was 46%. Paired t-tests, McNemar tests, and linear and logistic regression were used to examine differences in smoking cessation outcomes within and between groups.ResultsParticipants in the Enhanced Group (β = -1.28, 95%CI: -2.13, -0.44) and the Standard Group (β = -1.13, 95%CI: -1.95, -0.30) reported larger changes in nicotine dependence scores, compared to participants in the Waitlist Group. No statistically significant differences were found between the Enhanced Group and the Standard Group.DiscussionThis WeChat-based intervention was effective for smoking cessation overall. The addition of oral health information did not significantly improve the intervention.

Project description:As a composite concept, negative affect comprises various aversive emotional experiences, such as irritability and nervousness. It is a critical motivational factor that helps maintain smoking behavior, and contributes significantly to smoking cessation failure as a core withdrawal symptom. Prior research has indicated an important role of nicotinic mechanisms in negative affect processing. The most effective smoking cessation medication, varenicline, targets nicotinic acetylcholine receptors (nAChRs) as a partial agonist, while another first-line cessation medication, bupropion, has shown antagonistic effects on nAChRs. Therefore, it is possible that both medications work to reduce smoking behavior through modulating negative affect processing. To evaluate this hypothesis, we examined the impact of varenicline tartrate and bupropion hydrochloride sustained-release on electrophysiological responses to affective, cigarette-related, and neutral cues before and during smoking cessation treatment in a randomized placebo-controlled clinical trial. The participants were 206 smokers, a subset of 294 participants that were enrolled in a larger smoking cessation clinical trial who were randomly assigned to one medication group for 12weeks. Orbicularis oculi (startle eyeblink response) and corrugator supercilii facial electromyographic (EMG) reactivity toward emotional pictures (i.e., pleasant and unpleasant) in a picture-viewing task were measured before treatment and 2 and 6weeks after treatment was started. The startle and corrugator EMG activities increase with the exposure to unpleasant cues, and served as indices for negative emotional reactivity (NER). We found that after 6weeks, drug reduced startle-related NER in the varenicline group, but not in the bupropion or placebo group. Independent of medication treatment, lower baseline NER, as measured by the corrugator EMG activity, predicted a higher likelihood of smoking abstinence 1 and 3months after quitting smoking. These findings indicate the important roles of varenicline in negative affect processing and negative emotional reactivity in the course of smoking cessation.

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Adaptation of a sustained care cessation intervention for smokers hospitalized for psychiatric disorders: Study protocol for a randomized controlled trial.

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Adaptation of a sustained care cessation intervention for smokers hospitalized for psychiatric disorders: Study protocol for a randomized controlled trial.

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