Making lemonade from SARS coronavirus-2 lemons: Transitioning a smoking cessation trial to a virtual platform.
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ABSTRACT:
SUBMITTER: Mahoney MC
PROVIDER: S-EPMC7403863 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Making lemonade from SARS coronavirus-2 lemons: Transitioning a smoking cessation trial to a virtual platform.
Mahoney Martin C MC Ashare Rebecca R Schlienz Nicolas N Duerr CeCe C Hawk Larry W LW
Journal of substance abuse treatment 20200805
Clinical trials represent an essential component of improving treatment for substance use disorders (SUD). The SARS coronavirus-2 pandemic disrupted our ongoing clinical trial of smoking cessation and forced us to rapidly implement changes to assure participants access to ongoing counseling and monitoring via telephone calls and/or video chat sessions. Our experiences suggest that this pandemic will lead to changes for both future clinical trial participants and project staff. While challenges r ...[more]
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Project description:BackgroundThe pandemic of SARS-CoV-2, which causes COVID-19, has caused disruptions in ongoing clinical trials and is expected to accelerate interest in conducting research studies remotely.ObjectiveA quasi-experimental, mixed methods approach was used to examine the rates of visit completion as well as the opinions and experiences of participants enrolled in an ongoing clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or telephone conferencing due to the COVID-19 pandemic.MethodsFor quantitative comparisons, we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, COVID-19 cohort) to a comparable cohort of participants followed over a similar time period in the calendar years 2018 and 2019 (n=51, pre-COVID-19 cohort) to examine the rates of completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from in-person to remote visits.ResultsParticipants in the COVID-19 cohort completed an average of 83.6% of remote clinic visits (95% CI 73.1%-91.2%), which was not significantly different than the in-person completion rate of 89.8% in the pre-COVID-19 cohort. Participants in the COVID-19 cohort returned an average of 93.2% (95% CI 83.5%-98.1%) of saliva specimens for remote clinic visits completed, which was not significantly different than the in-person saliva specimen completion rate of 100% in the pre-COVID-19 cohort. Two broad themes emerged from the qualitative data: (1) the benefits of remote visits and (2) the challenges of remote counseling compared to in-person counseling. Despite limited experience with telehealth prior to this transition, most participants expressed a willingness to engage in remote visits in the future.ConclusionsEven in the context of a rapid transition from in-person to remote visits necessitated by the COVID-19 pandemic, rates of visit completion and return of biospecimens remained high. Participants were generally accepting of the transition. Further research is needed to identify the optimal mix of in-person and remote visits beyond the pandemic context and to better understand how these changes may impact study outcomes.Trial registrationClinicalTrials.gov NCT03262662; https://clinicaltrials.gov/ct2/show/study/NCT03262662.
| S-EPMC8092028 | biostudies-literature
Project description:OBJECTIVE:To assess the efficacy of an interactive smoking cessation decision-aid application (pp) compared with a smoking cessation static information app on continuous abstinence. DESIGN:Automated double-blind randomised controlled trial with 6 months follow-up (2014-2015). SETTING:Smartphone-based. PARTICIPANTS:684 participants (daily smokers of cigarettes, 18 years old or over) recruited passively from app stores in the USA, Australia, UK and Singapore, and randomised to one of two sub-apps. INTERVENTIONS:Behavioural, decision-aid, smartphone application. MAIN OUTCOMES:Continuous abstinence at 10 days, 1?month, 3 months and 6 months. RESULTS:Smokers who received the decision-aid app were more likely to be continuously abstinent at 1?month compared with the information-only app (28.5% vs 16.9%; relative risk (RR) 1.68; 95%?CI 1.25 to 2.28). The effect was sustained at 3 months (23.8% vs 10.2%; RR 2.08; 95%?CI 1.38 to 3.18) and 6 months (10.2% vs 4.8%; RR 2.02; 95%?CI 1.08 to 3.81). Participants receiving the decision-aid app were also more likely to have made an informed choice (31.9% vs 19.6%) and have lower decisional conflict (19.5% vs 3.9%). CONCLUSION:A smartphone decision-aid app with support features significantly increased smoking cessation and informed choice. With an increasing number of smokers attempting to quit, unassisted evidence-based decision-aid apps can provide an effective and user-friendly option to many who are making quit decisions without healthcare professionals. TRIAL REGISTRATION NUMBER:ACTRN12613000833763.
| S-EPMC5780681 | biostudies-other
Project description:Set of microarray experiments used to identify an unknown coronavirus in a viral culture derived from a patient with SARS. March 2003. Keywords = SARS Keywords = coronavirus Keywords = viral discovery Keywords = viruses Keywords = respiratory infection
2010-06-05 | E-GEOD-546 | biostudies-arrayexpress
Project description:The focus on acute care, time pressure, and lack of resources hamper the delivery of smoking cessation interventions in the emergency department (ED). The aim of this study was to 1) determine the effect of an emergency nurse-initiated intervention on delivery of smoking cessation counseling based on the 5As framework (ask-advise-assess-assist-arrange) and 2) assess ED nurses' and physicians' perceptions of smoking cessation counseling.The authors conducted a pre-post trial in 789 adult smokers (five or more cigarettes/day) who presented to two EDs. The intervention focused on improving delivery of the 5As by ED nurses and physicians and included face-to-face training and an online tutorial, use of a charting/reminder tool, fax referral of motivated smokers to the state tobacco quitline for proactive telephone counseling, and group feedback to ED staff. To assess ED performance of cessation counseling, a telephone interview of subjects was conducted shortly after the ED visit. Nurses' and physicians' self-efficacy, role satisfaction, and attitudes toward smoking cessation counseling were assessed by survey. Multivariable logistic regression was used to assess the effect of the intervention on performance of the 5As, while adjusting for key covariates.Of 650 smokers who completed the post-ED interview, a greater proportion had been asked about smoking by an ED nurse (68% vs. 53%, adjusted odds ratio [OR] = 2.0, 95% confidence interval [CI] = 1.3 to 2.9), assessed for willingness to quit (31% vs. 9%, adjusted OR= 4.9, 95% CI = 2.9 to 7.9), and assisted in quitting (23% vs. 6%, adjusted OR = 5.1, 95% CI = 2.7 to 9.5) and had arrangements for follow-up cessation counseling (7% vs. 1%, adjusted OR = 7.1, 95% CI = 2.3 to 21) during the intervention compared to the baseline period. A similar increase was observed for emergency physicians (EPs). ED nurses' self-efficacy and role satisfaction in cessation counseling significantly improved following the intervention; however, there was no change in "pros" and "cons" attitudes toward smoking cessation in either ED nurses or physicians.Emergency department nurses and physicians can effectively deliver smoking cessation counseling to smokers in a time-efficient manner. This trial also provides empirical support for expert recommendations that call for nursing staff to play a larger role in delivering public health interventions in the ED.
| S-EPMC3334343 | biostudies-literature
Project description:Genetic Architecture of Smoking and Smoking Cessation
| PRJNA75689 | ENA
Project description:ImportanceThe National Lung Screening Trial (NLST) found a reduction in lung cancer mortality among participants screened with low-dose computed tomography vs chest radiography. In February 2015, Medicare announced its decision to cover annual lung screening for patients with a significant smoking history. These guidelines promote smoking cessation treatment as an adjunct to screening, but the frequency and effectiveness of clinician-delivered smoking cessation interventions delivered after lung screening are unknown.ObjectiveTo determine the association between the reported clinician-delivered 5As (ask, advise, assess, assist [talk about quitting or recommend stop-smoking medications or recommend counseling], and arrange follow-up) after lung screening and smoking behavior changes.Design, setting, and participantsA matched case-control study (cases were quitters and controls were continued smokers) of 3336 NLST participants who were smokers at enrollment examined participants' rates and patterns of 5A delivery after a lung screen and reported smoking cessation behaviors.Main outcomes and measuresPrevalence of the clinician-delivered 5As and associated smoking cessation after lung screening.ResultsDelivery of the 5As 1 year after screening were as follows: ask, 77.2%; advise, 75.6%; assess, 63.4%; assist, 56.4%; and arrange follow-up, 10.4%. Receipt of ask, advise, and assess was not significantly associated with quitting in multivariate models that adjusted for sociodemographic characteristics, medical history, screening results, nicotine dependence, and motivation to quit. Assist was associated with a 40% increase in the odds of quitting (odds ratio, 1.40; 95% CI, 1.21-1.63), and arrange was associated with a 46% increase in the odds of quitting (odds ratio, 1.46; 95% CI, 1.19-1.79).Conclusions and relevanceAssist and arrange follow-up delivered by primary care providers to smokers who were participating in the NLST were associated with increased quitting; less intensive interventions (ask, advise, and assess) were not. However, rates of assist and arrange follow-up were relatively low. Our findings confirm the need for and benefit of clinicians taking more active intervention steps in helping patients who undergo screening to quit smoking.
| S-EPMC5089370 | biostudies-literature
Project description:The focus on acute care, time pressure, and lack of resources hamper the implementation of smoking cessation guidelines in the emergency department (ED). The purpose of this study was to determine whether an emergency nurse- initiated intervention based on the 5A's (Ask-Advise-Assess-Assist-Arrange) framework improves quit rates.We conducted a pre-post implementation trial in 789 adult smokers who presented to two EDs in Iowa between August 13, 2008 and August 4, 2010. The intervention focused on improving delivery of the 5A's by ED nurses and physicians using academic detailing, charting/reminder tools, and group feedback. Performance of ED cessation counseling was measured using a 5A's composite score (ranging from 0 to 5). Smoking status was assessed by telephone interview at 3- and 6-month follow-up (with biochemical confirmation in those participants who reported abstinence at 6-month follow-up).Based on data from 650 smokers who completed the post-ED interview, there was a significant improvement in the mean 5A's composite score for emergency nurses during the intervention period at both hospitals combined (1.51 vs. 0.88, difference = 0.63, 95% confidence interval [CI] [0.41, 0.85]). At 6-month follow-up, 7-day point prevalence abstinence (PPA) was 6.8 and 5.1% in intervention and preintervention periods, respectively (adjusted odds ratio [OR] = 1.7, 95% CI [0.99, 2.9]).It is feasible to improve the delivery of brief smoking cessation counseling by ED staff. The observed improvements in performance of cessation counseling, however, did not translate into statistically significant improvements in cessation rates. Further improvements in the effectiveness of ED cessation interventions are needed.
| S-EPMC6080418 | biostudies-literature
Project description:Stop smoking it is often associated to weight gain that is one of the most important causes for relapse. This is the first study to describe long-term changes in body weight in smokers invited to quit or reduce smoking by switching to ECs. Conventional cigarettes consumption and body weight were measured prospectively in a randomized controlled trial of smokers invited to switch to ECs. Post cessation weight changes from baseline at week-12, -24 and -52 were compared among 1) high, medium and zero nicotine strength products and 2) pooled continuous smoking failure, smoking reduction and abstinence phenotypes. Saliva cotinine levels and appetite levels were also measured. No significant changes in body weight were observed among high, medium and zero nicotine strength products. Differences among continuous smoking phenotypes were significant only at week-12 (p = 0.010) and week-24 (p = 0.012) with quitters gaining 2.4{plus minus}4.3 Kg and 2.9{plus minus}4.4 Kg respectively. However, weight gain at week-52 (1.5{plus minus}5.0 Kg) was no longer significant compared to Failures and Reducers. No confounding factors could explain the significant changes in body weight. Smokers who quit smoking by switching to ECs may limit their post-cessation weight gain, with substantial reversal in weight gain being manifest at late time points.
| S-EPMC4700433 | biostudies-other
Project description:Adjunctive behavioral smoking cessation treatments have the potential to improve outcomes beyond standard care. The present study had two aims: (1) compare standard care (SC) for smoking (four weeks of brief counseling and monitoring) to SC plus prize-based contingency management (CM), involving the chance to earn prizes on days with demonstrated smoking abstinence (carbon monoxide (CO) ?6 ppm); and (2) compare the relative efficacy of two prize reinforcement schedules-one a traditional CM schedule, and the second an early enhanced CM schedule providing greater reinforcement magnitude in the initial week of treatment but equal overall reinforcement.Participants (N=81 nicotine-dependent cigarette smokers) were randomly assigned to one of the three conditions.Prize CM resulted in significant reductions in cigarette smoking relative to SC. These reductions were not apparent at follow-up. We found no meaningful differences between the traditional and enhanced CM conditions.Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention, but the benefits did not extend long-term.
| S-EPMC5020416 | biostudies-literature
Project description:Some cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting.To determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction.Randomized, double-blind, placebo-controlled, multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 countries. The 1510 participants were cigarette smokers who were not willing or able to quit smoking within the next month but willing to reduce smoking and make a quit attempt within the next 3 months. Participants were recruited through advertising.Twenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with a reduction target of 50% or more in number of cigarettes smoked by 4 weeks, 75% or more by 8 weeks, and a quit attempt by 12 weeks.Primary efficacy end point was carbon monoxide-confirmed self-reported abstinence during weeks 15 through 24. Secondary outcomes were carbon monoxide-confirmed self-reported abstinence for weeks 21 through 24 and weeks 21 through 52.The varenicline group (n?=?760) had significantly higher continuous abstinence rates during weeks 15 through 24 vs the placebo group (n?=?750) (32.1% for the varenicline group vs 6.9% for the placebo group; risk difference (RD), 25.2% [95% CI, 21.4%-29.0%]; relative risk (RR), 4.6 [95% CI, 3.5-6.1]). The varenicline group had significantly higher continuous abstinence rates vs the placebo group during weeks 21 through 24 (37.8% for the varenicline group vs 12.5% for the placebo group; RD, 25.2% [95% CI, 21.1%-29.4%]; RR, 3.0 [95% CI, 2.4-3.7]) and weeks 21 through 52 (27.0% for the varenicline group vs 9.9% for the placebo group; RD, 17.1% [95% CI, 13.3%-20.9%]; RR, 2.7 [95% CI, 2.1-3.5]). Serious adverse events occurred in 3.7% of the varenicline group and 2.2% of the placebo group (P?=?.07).Among cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt at 3 months, use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates at the end of treatment, and also at 1 year. Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation.clinicaltrials.gov Identifier: NCT01370356.
| S-EPMC4883651 | biostudies-literature