Recruiting unmotivated smokers into a smoking induction trial.
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ABSTRACT:
SUBMITTER: Harris KJ
PROVIDER: S-EPMC4872594 | biostudies-literature | 2016 Jun
REPOSITORIES: biostudies-literature
Publications
Recruiting unmotivated smokers into a smoking induction trial.
Harris Kari Jo KJ Bradley-Ewing Andrea A Goggin Kathy K Richter Kimber P KP Patten Christi C Williams Karen K Lee Hyoung S HS Staggs Vincent S VS Catley Delwyn D
Health education research 20160413 3
Little is known about effective methods to recruit unmotivated smokers into cessation induction trials, the reasons unmotivated smokers agree to participate, and the impact of those reasons on study outcomes. A mixed-method approach was used to examine recruitment data from a randomized controlled cessation induction trial that enrolled 255 adult smokers with low motivation to quit. Over 15 months, 33% of smokers who inquired about the study were enrolled. Common recruitment methods included wor ...[more]
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Project description:Many smokers remain unwilling or unable to make a quit attempt. For these smokers, novel strategies to induce quit attempts are necessary to achieve further reductions in smoking prevalence.This article describes the design and methods of an ongoing nationwide telephone-based clinical trial for cessation induction, the principal aim of which is to test the hypothesis that samples of nicotine replacement therapy (NRT), can induce quit attempts among smokers otherwise unmotivated to quit.Smokers are recruited proactively through online channels. A 'behavioral filter' is used to identify and separate motivated versus unmotivated smokers, the latter of whom (N = 750) are formally entered into the clinical trial. Participants are randomized to one of two treatment conditions designed to promote self-efficacy and motivation to quit: (1) practice quit attempt (PQA) or (2) PQA plus NRT sampling. The primary outcome measure tested over a 6-month follow-up is the incidence of additional quit attempts as well as hypothesized mediators of treatment effects.This study details the challenges of identifying and treating smokers who are unmotivated to quit. Strengths include a novel treatment approach, tested among a group of proactively recruited smokers nationwide, with a unique method of identifying cessation-resistant smokers.The omission of a true control group, testing the effect of the PQA itself, is an inherent limitation to the study design. Online recruitment presents additional study challenges, all of which are discussed in detail.The study has translational potential to guide both clinical and policy recommendations for cessation induction. Further, while the focus is on smoking, this trial may serve as an example to researchers and clinicians who focus on other health behaviors, and who themselves are challenged with motivating people who are unmotivated for change.
| S-EPMC2902976 | biostudies-literature
Project description:IntroductionRecruiting racial/ethnic minorities in smoking cessation trials is a priority. This study described lessons learned from recruiting a diverse sample of African American, White, and Hispanic/Latinx smokers in a smoking cessation trial.MethodsWe implemented a 42-month recruitment campaign utilizing reactive (e.g., word-of-mouth, newspaper, radio, online ads, flyers, community partnerships) and proactive (e.g., direct invitations) strategies. We included 821 participants in the analysis. We described our recruitment strategies' implementation, their enrollment yield and rate (number enrolled/number screened) by race/ethnicity, and direct cost-per-participant (CPP: total cost/number of enrolled) for paid strategies.ResultsEnrollment yields were higher using reactive strategies than proactive strategies (94.3% vs. 5.7%). The top source of enrollment was word-of-mouth among African Americans (36%) and Whites (44%), and flyers among Hispanics/Latinxs (34%). Proactive recruitment, word-of-mouth, and flyers were more successful among African Americans than other groups. Newspaper and online ads were more successful among Hispanics/Latinxs than other groups (P < .05). Word-of-mouth was cost-free and yielded 23.1% of enrollment. The most economic method among paid strategies was flyer distribution (CPP = $47.6; yield 17.5%), followed by newspaper ($194.7; 23.7%) and online advertisements ($264.6; 24.0%). Radio and television ads were the most expensive and produced the least participant yield ($4,755.6; 0.8%).ConclusionRecruiting racially/ethnically diverse samples into smoking cessation clinical trials requires implementing multiple strategies and adjusting these strategies based on their enrollment yield and cost. Word-of-mouth, flyers, and newspaper and online ads were more successful among racial/ethnic minorities. Flyers and newspaper ads were the most economic methods for recruitment.
| S-EPMC8511330 | biostudies-literature
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:BackgroundAlthough the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition.Methods/designA sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation.DiscussionThis trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline.Trial registrationClinicalTrials.gov NCT01188018.
| S-EPMC3487752 | biostudies-literature
Project description:Recruiting pregnant smokers into clinical trials is challenging since this population tends to be disadvantaged, the behavior is stigmatized, and the intervention window is limited. The purpose of this study is to test the feasibility and effectiveness of recruiting pregnant smokers into a smoking cessation trial by sending recruitment text messages to an existing subscriber list. Recruitment messages were sent to subscribers flagged as pregnant in Text4baby, a national text messaging program for pregnant women and mothers. Four recruitment messages were rotated to test the effectiveness of different emotional frames and a financial incentive. Study staff called subscribers who expressed interest to screen for eligibility and enroll eligible women. Between October 6, 2015 and February 2, 2016, 10,194 recruitment messages were sent to Text4baby subscribers flagged as pregnant, and 10.18% (1038) responded indicating interest. No significant increase in cancellation was observed compared to subscribers who received other ad hoc messages. Of respondents, 54.05% (561) were reached by phone for follow-up, and 21.97% (228) were found to be eligible. Among the eligible, 87% (199) pregnant smokers enrolled. The recruitment message with a pride emotional appeal had a significantly higher response (p = 0.02) compared to the recruitment message with no emotional appeal, but enrollment did not significantly differ between recruitment messages with different emotional appeals. The recruitment messages with a reference to financial incentive yielded higher response (p < 0.01) and enrollment (p = 0.03) compared to a recruitment message without. This study demonstrates success recruiting pregnant smokers using text message. Future studies should consider building on this approach for recruiting high-risk populations.
| S-EPMC5526806 | biostudies-other
Project description:Individual-level interventions for smokers unmotivated to quit remain scarce and have had limited success. Little is known about the potential of virtual reality (VR) for delivering messaging to smokers unmotivated to quit. This pilot trial aimed to assess the feasibility of recruitment and acceptability of a brief, theory-informed VR scenario and estimate proximal quitting outcomes. Unmotivated smokers (recruited between February-August 2021) aged 18+ years who had access to, or were willing to receive via post, a VR headset were randomly assigned (1:1) using block randomisation to view the intervention (i.e., a hospital-based scenario with motivational stop smoking messaging) or a 'sham' VR scenario (i.e., a scenario about the human body without any smoking-specific messaging) with a researcher present via teleconferencing software. The primary outcome was feasibility of recruitment (i.e., achieving the target sample size of 60 participants within 3 months of recruitment). Secondary outcomes included acceptability (i.e., positive affective and cognitive attitudes), quitting self-efficacy and intention to stop smoking (i.e., clicking on a weblink with additional stop smoking information). We report point estimates and 95% confidence intervals (CIs). The study protocol was pre-registered (osf.io/95tus). A total of 60 participants were randomised within 6 months (intervention: n = 30; control: n = 30), 37 of whom were recruited within a 2-month period of active recruitment following an amendment to gift inexpensive (£7) cardboard VR headsets via post. The mean (SD) age of participants was 34.4 (12.1) years, with 46.7% identifying as female. The mean (SD) cigarettes smoked per day was 9.8 (7.2). The intervention (86.7%, 95% CI = 69.3%-96.2%) and control (93.3%, 95% CI = 77.9%-99.2%) scenarios were rated as acceptable. Quitting self-efficacy and intention to stop smoking in the intervention (13.3%, 95% CI = 3.7%-30.7%; 3.3%, 95% CI = 0.1%-17.2%) and control (26.7%, 95% CI = 12.3%-45.9%; 0%, 95% CI = 0%-11.6%) arm were comparable. The target sample size was not achieved within the feasibility window; however, an amendment to gift inexpensive headsets via post appeared feasible. The brief VR scenario appeared acceptable to smokers unmotivated to quit.
| S-EPMC9931367 | biostudies-literature
Project description:To help tobacco control research better include vulnerable populations, we sought to identify effective ways to recruit diverse smokers. In 2014-2015, we recruited 2149 adult cigarette smokers in California and North Carolina, United States, to participate in a randomized trial of pictorial cigarette pack warnings. The most effective means of recruiting smokers were the classified advertising website Craigslist (28% of participants), word of mouth (23%), Facebook (16%), and flyers or postcards (14%). Low-income and African American smokers were more likely to respond to interpersonal contact (including staff in-person recruitment and word of mouth) than were high-income and non-African American smokers (all p < 0.05). Hispanic and gay, lesbian, and bisexual smokers were more likely to be recruited by Craigslist than non-Hispanic and straight smokers (both p < 0.05). Of the recruitment methods requiring cost, the cheapest was Craigslist ($3-7 per smoker). The most expensive methods were newspaper ads in California ($375 per smoker) and staff in-person recruiting in North Carolina ($180 per smoker). Successfully recruiting diverse smokers requires using multiple methods including interpersonal, online, and other media. Craigslist and word of mouth are especially useful and low-cost ways to recruit diverse smokers.
| S-EPMC5201392 | biostudies-other
Project description:BackgroundSuccessful recruitment of participants to mobile health (mHealth) studies presents unique challenges over in-person studies. It is important to identify recruitment strategies that maximize the limited recruitment resources available to researchers.ObjectiveThe objective of this study was to describe a case study of a unique recruitment process used in a recent mHealth software app designed to increase smoking cessation among weight-concerned women smokers. The See Me Smoke-Free app was deployed to the Google Play Store (Alphabet, Inc., Google, LLC), where potential participants could download the app and enroll in the study. Users were invited in-app to participate in the study, with no in-person contact. The recruitment activities relied primarily on earned (free) and social media.MethodsTo determine the relationship between recruitment activities and participant enrollment, the researchers explored trends in earned and social media activity in relation to app installations, examined social media messaging in relation to reach or impressions, and described app users' self-reported referral source. The researchers collected and descriptively analyzed data regarding recruitment activities, social media audience, and app use during the 18-week recruitment period (March 30, 2015-July 31, 2015). Data were collected and aggregated from internal staff activity tracking documents and from Web-based data analytics software such as SumAll, Facebook Insights (Facebook, Inc.), and Google Analytics (Alphabet, Inc., Google, LLC).ResultsMedia coverage was documented across 75 publications and radio or television broadcasts, 35 of which were local, 39 national, and 1 international. The research team made 30 Facebook posts and 49 tweets, yielding 1821 reaches and 6336 impressions, respectively. From March 30, 2015 to July 31, 2015, 289 unique users downloaded the app, and 151 participants enrolled in the study.ConclusionsResearch identifying effective online recruitment methods for mHealth studies remains minimal, and findings are inconsistent. We demonstrated how earned media can be leveraged to recruit women to an mHealth smoking cessation trial at low cost. Using earned media and leveraging social media allowed us to enroll 3 times the number of participants that we anticipated enrolling. The cost of earned media resides in the staff time required to manage it, particularly the regular interaction with social media. We recommend communication and cooperation with university public affairs and social media offices, as well as affiliate programs in journalism and communications, so that earned media can be used as a recruitment strategy for mHealth behavior change interventions. However, press releases are not always picked up by the media and should not be considered as a stand-alone method of recruitment. Careful consideration of an intervention's broad appeal and how that translates into potential media interest is needed when including earned media as part of a comprehensive recruitment plan for mHealth research.
| S-EPMC5695655 | biostudies-literature
Project description:BackgroundWith smoking rates far exceeding the general population, methadone-maintained (MMT) opiate-dependent smokers experience high rates of tobacco-related health consequences. Previous treatment studies have used nicotine replacement and produced low quit rates.MethodsWe test, using a three-group randomized design, the efficacy of varenicline versus placebo, in comparison with nicotine replacement therapy (NRT) that combines nicotine patch prescription plus ad libitum nicotine rescue, for smoking cessation. We recruited methadone-maintained smokers from nine treatment centers in southern New England and provided six months of treatment, and a minimal behavioral intervention at baseline (NCI's 5A's). Outcomes included carbon monoxide (CO) confirmed 7-day point smoking cessation prevalence at 6 months and self-reported change in mean cigarettes per day.ResultsThe 315 participants had a mean age of 40, with 50% male and 79% non-Hispanic White, smoked an average of 19.6 (± 10.4) cigarettes/day, and had a mean daily methadone dose of 109 mg. Intent-to-treat analyses, with missing considered to be smoking, showed the rate of CO-confirmed 7-day abstinence at 6-months was 5.4% overall, with varenicline 3.7% compared to placebo 2.2%, and NRT 8.3% (p>.05). Adherence rates during the 7-days immediately prior to 6-month assessment were 34.2% in varenicline, 34.4% in placebo, and 48.8% in NRT. Between baseline and 6-months there was an overall self-reported mean reduction of 8.3 cigarettes/day.ConclusionVarenicline did not increase quit rates over placebo. Smoking cessation rates in methadone-maintained smokers are low and novel treatment strategies are required.
| S-EPMC3818400 | biostudies-literature
Project description:IntroductionMethadone maintenance treatment (MMT) patients have an exceedingly high prevalence of tobacco use, and interventions that have been specifically developed for this vulnerable subpopulation have struggled to attain even modest rates of cessation. A significant barrier has been an inability to initiate a quit attempt early in the treatment process and adherence to treatment.MethodsThis study examined the extent to which self-efficacy, medication adherence, and other demographic and smoking variables predicted an early quit day in a sample of MMT smokers (n = 315) enrolled in a smoking cessation pharmacotherapy trial. Using logistic regression, we estimated the association of having an early quit day-24hr without smoking during the first month of treatment.ResultsOnly 35.2% of participants reported a successful early quit day. The likelihood of an early quit day increased significantly (odds ratio [OR] = 1.39, 95% CI = 1.04-1.86, p < .05) with education level and if a quit attempt was made in the past year (OR = 2.27, 95% CI = 1.33-3.87, p < .01). Compared to the placebo arm, those randomized to either nicotine replacement therapy (OR = 3.25, 95% CI = 1.30-8.10, p < .01) or varenicline (OR = 3.16, 95% CI = 1.26-7.92) were significantly more likely to have an early quit day. The likelihood of an early quit day was also positively associated with adherence to the medication protocol (OR = 2.05, 95% CI = 1.52-2.76).ConclusionsDifficulty in achieving an early quit attempt may help explain the very low cessation rates found in studies of MMT smokers.
| S-EPMC4271088 | biostudies-literature