Increasing treatment enrollment among smokers who are not motivated to quit: a randomized clinical trial.
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SUBMITTER: Vinci C
PROVIDER: S-EPMC8764989 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Increasing treatment enrollment among smokers who are not motivated to quit: a randomized clinical trial.
Vinci Christine C Lam Cho C Schlechter Chelsey R CR Shono Yusuke Y Vidrine Jennifer I JI Wetter David W DW
Translational behavioral medicine 20220101 1
There is a significant research-to-practice gap with respect to reaching underserved populations with evidence-based tobacco cessation treatments. Increasing enrollment in evidence-based treatments is necessary to reduce tobacco use and tobacco-related health inequities. The purpose of the current study was to evaluate whether Motivation And Problem Solving (MAPS), a flexible, holistic counseling/navigation approach delivered via phone, and proactive provision of Nicotine Replacement Therapy (NR ...[more]
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Project description:BackgroundRates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts.MethodsWithin a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring self-defined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment.ResultsCompared with PQA intervention, nicotine therapy sampling was associated with a significantly higher incidence of any quit attempt (49% vs 40%; relative risk [RR], 1.2; 95% CI, 1.1-1.4) and any 24-hour quit attempt (43% vs 34%; 1.3; 1.1-1.5). Nicotine therapy sampling was marginally more likely to promote floating abstinence (19% vs 15%; RR, 1.3; 95% CI, 1.0-1.7); 6-month point prevalence abstinence rates were no different between groups (16% vs 14%; 1.2; 0.9-1.6).ConclusionNicotine therapy sampling during a PQA represents a novel strategy to motivate smokers to make a quit attempt.Trial registrationclinicaltrials.gov Identifier: NCT00706979.
| S-EPMC3372898 | biostudies-literature
Project description:IntroductionLinking outpatient cessation services to bedside counseling for hospitalized smokers can improve long-run quit rates. Adding an assisted referral (AR) offer to a tobacco treatment specialist consult service fits the team approach to care in U.S. hospitals.DesignA two-arm patient-randomized trial tested the effectiveness of adding an AR offer to outpatient smoking-cessation services and interactive voice recognition (AR+IVR) follow-up to a usual care (UC) tobacco-cessation consult for hospitalized smokers.Setting/participantsOver 24 months (November 2011-November 2013), 898 hospitalized adult smokers interested in quitting smoking were recruited from three large hospitals in the Portland, Oregon, area: an integrated group model HMO (n=622), a community hospital (n=195), and an academic health center (n=81).InterventionTobacco treatment specialists identified smokers and provided an intensive bedside tobacco use assessment and cessation consultation (UC). AR+IVR recipients also received proactive ARs to available outpatient counseling programs and medications, and linked patients to a tailored IVR telephone follow-up system.Main outcome measuresThe primary outcome was self-reported 30-day abstinence at 6-month follow-up. Secondary outcomes included self-reported and continuous abstinence and biochemically confirmed 7-day abstinence at 6 months. Follow-up was completed in September 2014; data were analyzed in 2015.ResultsA total of 597 and 301 hospitalized smokers were randomized to AR+IVR and UC, respectively. AR+IVR and UC recipients received 19.3 and 17.0 minutes of bedside counseling (p=0.372), respectively. Most (58%) AR+IVR patients accepted referrals for counseling, 43% accepted medications, and 28% accepted both. Self-reported 30-day abstinence for AR+IVR (17.9%) and UC (17.3%) were not statistically significant (p=0.569). Differences in 7-day, continuous, and biochemically confirmed abstinence by treatment group also were insignificant, overall and adjusting for site.ConclusionsAdding an AR to outpatient counseling and medications did not increase cigarette abstinence at 6 months compared to UC alone.
| S-EPMC5031367 | biostudies-literature
Project description:IntroductionCigarette smoking disproportionately affects communities of low socioeconomic status where greater smoking prevalence and poorer cessation rates have been observed. Utilizing brief evidence-based interventions to increase cessation attempts may be an effective and easily disseminable means by which to mitigate undue burden in this population.Aims and methodsThe current intervention randomized daily smokers (N = 57) recruited from a local community soup kitchen to receive either Brief (eg, 30 m) Motivational Interviewing, Nicotine Replacement Therapy (NRT) sampling, or a Referral-Only intervention. Approximately half of participants (50.9%) reported not completing high school and many reported either just (41.4%) or not (40.4%) meeting basic expenses. Follow-up was completed approximately 1-month postintervention.ResultsNonsignificant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size). Approximately 40% of the sample reported making a serious quit attempt at follow-up. Significant differences in cigarettes per day at follow-up, controlling for baseline, were observed, with participants in the Motivational Interviewing condition, only, reporting significant reductions. Participants randomized to the NRT condition were significantly more likely to report using NRT patch and lozenge at follow-up (large effect). There were no differences between groups with respect to seeking behavioral support. Finally, we found that subjective financial strain moderated the effect of condition on change in cigarette consumption where NRT sampling was more effective for participants reporting less financial strain.ConclusionsFindings provide initial evidence for personalizing brief interventions to promote quit attempts in low-income smokers.ImplicationsWhile most clinical research on tobacco use and dependence focuses on successful sustained abstinence, the current study is novel because it examined three brief interventions designed to increase the number of quit attempts made by a nontreatment-seeking group suffering from health disparities (ie, smokers from socioeconomic disadvantage). These data suggest that nontreatment-seeking smokers from socioeconomic disadvantage can be influenced by Brief MIs and these interventions should be used to motivate smokers from socioeconomic disadvantage to make a quit attempt. Future studies should examine combined MIs including pharmacological and behavioral interventions.
| S-EPMC7899481 | biostudies-literature
Project description:Tobacco smokers with co-occurring pain report greater difficulty quitting, face unique cessation challenges, and may benefit from targeted smoking interventions. We developed and tested a brief motivational intervention aimed at increasing knowledge of pain-smoking interrelations, motivation to quit, and cessation treatment engagement among smokers in pain. Nontreatment seeking daily cigarette smokers with chronic pain (N = 76, 57.9% women, 52.6% White) were randomized to the targeted or ask, advise, refer (AAR) intervention. The targeted intervention included personalized feedback and pain-smoking psychoeducation to help participants develop discrepancy between continued smoking and desired pain outcomes. At postintervention, the targeted intervention (vs. AAR) increased knowledge of pain-smoking interrelations and several indices of motivation to quit smoking (ps < .01). Participants who received the targeted intervention were also more likely to accept information about and report intention to engage evidence-based cessation treatments (ps < .05). Increased knowledge of pain-smoking interrelations mediated postintervention effects on motivation to quit and willingness to learn about treatments. At 1-month follow up, gains in knowledge of pain-smoking interrelations were maintained (p = .009). Participants who received the targeted intervention were more likely to report having subsequently engaged cessation treatment (p = .019), but this was not mediated by increased knowledge of pain-smoking interrelations. Smokers with chronic pain may benefit from targeted interventions that address smoking in the context of pain. Smokers in pain may become increasingly motivated to quit and engage cessation treatment as they become aware of how smoking may exacerbate their pain. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
| S-EPMC8499853 | biostudies-literature
Project description:IntroductionLow-nitrosamine smokeless tobacco (SLT) may have efficacy for smoking reduction and cessation, but its public health impact depends on how smokers use it.MethodsThis pilot study explored brief, instructional low-nitrosamine SLT use among smokers unmotivated to quit. Participants (N = 57) were randomized to either a free 2-week supply of Camel Snus group or a no-supply group. Of those randomized to use Camel Snus, half were told to use it to cope with smoking restrictions (Snus to Cope), and the remaining half were advised to use it to reduce smoking (Snus to Reduce). Participants were assessed before, during, and immediately after the intervention.ResultsMany Snus to Cope and Snus to Reduce participants reported daily use of Camel Snus, although the amount of use was low. Snus to Cope (18.4%) and Snus to Reduce (37.6%) participants reported a decline in number of cigarettes used per day, which was not reported by the control participants (p < .001). Intention to quit smoking and intention to quit all tobacco use (ps < .001) increased to a greater extent among Snus to Cope and Snus to Reduce participants than among control participants.ConclusionsThis study replicates previous work that shows that low-nitrosamine SLT use can lead to reduced smoking and increased intention to quit, and it adds direct evidence to suggest that the function of low-nitrosamine SLT use-either to cope with smoking restrictions or to reduce smoking-can have a differential impact on smoking behavior. Overall, the results highlight the importance of messaging and, more specifically, marketing of low-nitrosamine SLT to smokers.
| S-EPMC3954419 | biostudies-literature
Project description:BackgroundObservational studies and a few clinical trials suggest that use of low nitrosamine smokeless tobacco (snus) can facilitate smoking cessation. To better understand the real-world impact of snus on smoking behaviour, a large-scale, long-term clinical trial of naturalistic snus use among smokers is needed.Study designA nationwide clinical trial compared abstinence outcomes among smokers who were randomised to receive free samples of snus versus not. Participants (N=1236) were recruited throughout the US and assessed for 1 year following a 6-week naturalistic sampling period, with high retention throughout. Primary outcomes included self-reported quit attempts, floating abstinence (any 7-day period of non-smoking) and 7-day point-prevalence abstinence at 6 months and 12 months. Secondary outcomes were changes in smoking, motivation and confidence to quit and adverse events. No tobacco industry support was provided.ResultsWithin snus group, 82% used at least once, and 16% were using regularly at end of sampling period. Compared to control participants, smokers in the snus group were less likely to make any quit attempt (RR=0.83; 95% CI 0.70 to 1.00), and any 24 h quit attempt (RR=0.77; 95% CI 0.63 to 0.95). There were no group differences on any measure of abstinence.ConclusionsProvision of snus in a naturalistic context resulted in minimal uptake, and as a whole, undermined quit attempts and did not increase smoking abstinence. Results do not support the unguided, free provision of snus among smokers not motivated to quit as a means to facilitate quit attempts.Trial registration numberNCT01509586, Results.
| S-EPMC5061602 | biostudies-literature
Project description:IntroductionDespite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing for inducing cessation-related behaviors among smokers with low motivation to quit.DesignRandomized clinical trial.Setting/participantsTwo-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010-2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014.InterventionFour sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients' own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit.Main outcomes measuresSelf-reported quit attempts; smoking abstinence (biochemically verified); use of cessation pharmacotherapies; motivation; and confidence to quit were assessed at baseline and 3- and 6-month follow-ups.ResultsUnexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% risk difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all p<0.05), and health education showed greater increases in motivation relative to Motivational Interviewing (Cohen's d=0.36, 95% CI=0.12, 0.60).ConclusionsAlthough Motivational Interviewing was generally more efficacious than brief advice in inducing cessation behaviors, health education appeared the most efficacious. These results highlight the need to identify the contexts in which Motivational Interviewing may be most efficacious and question recommendations to use Motivational Interviewing rather than other less complex cessation induction interventions.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01188018.
| S-EPMC4841713 | biostudies-literature
Project description:ImportanceMarginalized populations have lower levels of clinical trial representation than other populations. Tailoring recruitment materials and providing incentives may improve representation.ObjectiveTo determine whether culturally tailored video improves parents' decision to enroll (DTE) Black children in a research registry.Design, setting, and participantsA randomized clinical trial, using mixed methods and consecutive sampling, was conducted in an urban primary care pediatric clinic. A post hoc study assessed the association of a monetary incentive with DTE. Ninety-three parents were recruited before their child's scheduled clinic visit. Participants completed a survey during which they were randomly assigned to review a paragraph (control group), generic video, or tailored video and received a gift card. Video watchers completed questions about its effectiveness. All participants were invited to join the registry. In the post hoc study, consenting participants followed the control group protocol and the coordinator promised them an ink pen for participating. The study was conducted between November 15, 2022, and August 29, 2023.InterventionA survey regarding the importance of being included in research studies was administered after participants watched a culturally tailored video.Main outcome and measuresThe primary outcome was DTE. Covariates were message effectiveness, clinical trial knowledge, and trust. Intention-to-treat analysis was performed.ResultsA total of 125 individuals were included. All groups had similar mean (SD) parent age (overall, 32.6 [7.35] years), gender (110 [88.0%] women), and race (116 [92.8%] Black or African American). There was no significant difference in the odds of DTE between the appeal video and control (odds ratio [OR], 1.19; 95% CI, 0.38-3.72) or between the generic video and control (OR, 1.91; 95% CI, 0.54-6.71). However, DTE was higher for all 3 gift card groups vs the ink pen incentive group (eg, control vs ink pen incentive: OR, 5.01; 95% CI, 1.68-14.95). After adjusting for trust, monetary incentives were associated with higher odds of DTE (adjusted OR, 5.92; 95% CI, 2.44-14.39).Conclusions and relevanceIn this randomized clinical trial, targeted messaging was not associated with a higher decision to enroll in a pediatric clinical trial registry. There may be a role for combining holistic messaging with monetary incentives to improve enrollment.Trial registrationClinicalTrials.gov Identifier: NCT06138145.
| S-EPMC11558476 | biostudies-literature
Project description:BackgroundHigh rates of failure to qualify for clinical trial participation increase time and cost required for study completion. Identification of remediable reasons for prescreen failure can help reduce prescreen failure rates and improve study cost effectiveness.MethodsReasons for prescreen failure to qualify for participation in a phase 2 randomized clinical trial of treatment of uncomplicated urogenital gonorrhea were collected from prescreening logs. Reasons were categorized based on whether the reason was that the subject failed to meet eligibility criteria or declined participation. Subjects who failed prescreening but could have been enrolled under protocol amendments were used to estimate potential cost savings had enrollment completed sooner.ResultsOver 88% (1373/1554) of potential study candidates were not enrolled. The majority (68.8%) of nonenrolled subjects failed prescreening due to not meeting eligibility criteria, whereas 31.0% declined to participate. The most common reasons for failure to qualify were having only nonurogenital gonorrhea (16.4%), limited time (13.1%), and being on antiretroviral therapy (7.5%). Potential cost savings if protocol amendments affecting eligibility had been instituted earlier were estimated at US $127,500.ConclusionsCareful attention to reasons for prescreen failure can inform clinical trial protocol development to address trial design features that may impact successful enrollment. More efficient subject enrollment can result in substantial cost savings.
| S-EPMC5431289 | biostudies-literature
Project description:Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial
| PRJEB85138 | ENA