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Targeting mailed nicotine patch distribution interventions to rural regions of Canada: protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Quitting smoking is the most effective way of reducing the risk of cancer among smokers. One way of helping people stop smoking is to provide them with free Nicotine Replacement Therapy (NRT), such as when NRT is sent to people by postal mail as part of a mass distribution initiative. Our previous research indicated that there may be a substantial impact on increasing quit rates of a mailed NRT intervention in rural areas. The current research seeks to confirm this finding and to understand the social determinants of health driving these anticipated large effects. METHODS/DESIGN:Telephone numbers will be randomly selected from across rural regions of Canada in order to recruit adult smokers interested in completing a smoking survey and willing to be interviewed again in 6?months. The survey will ask participants about their smoking history, demographic characteristics, and a hypothetical question: would they be interested in receiving nicotine patches if they were provided to them free of charge? Half of the smokers interested in receiving nicotine patches will be selected by chance and offered the NRT package. The other half of smokers will not be offered the nicotine patches. In addition, the municipality where each participant lives will be identified and, once the relevant general population data becomes available, attempts will be made to link participant data to relevant municipal characteristics (e.g., smoking rates, availability of health services). Characteristics of the participants and the municipalities in which they live will be used to explain why the nicotine patch intervention may have a larger impact in some rural regions compared to others. DISCUSSION:The findings from the proposed RCT are timely and of high relevance as the distribution of nicotine patches has substantial potential to combat the public health problem of cigarette related cancer, other diseases, and premature death from tobacco use. Targeting such tobacco cessation initiatives to rural regions may substantially increase the impact of this intervention, helping to optimize the use of limited prevention resources while aiming to save the maximum number of lives. CLINICAL TRIALS REGISTRATION:ClinicalTrials.gov NCT04606797 , October, 27, 2020.

SUBMITTER: Cunningham JA

PROVIDER: S-EPMC7684960 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Targeting mailed nicotine patch distribution interventions to rural regions of Canada: protocol for a randomized controlled trial.

Cunningham John A JA Chaiton Michael M Leatherdale Scott T ST Godinho Alexandra A Schell Christina C

BMC public health 20201123 1

<h4>Background</h4>Quitting smoking is the most effective way of reducing the risk of cancer among smokers. One way of helping people stop smoking is to provide them with free Nicotine Replacement Therapy (NRT), such as when NRT is sent to people by postal mail as part of a mass distribution initiative. Our previous research indicated that there may be a substantial impact on increasing quit rates of a mailed NRT intervention in rural areas. The current research seeks to confirm this finding and ...[more]

PMID: 33228625

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Project description:Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required.A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline.The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment.ClinicalTrials.gov: NCT01429129.

Project description:BackgroundOur group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT.Methods/designTrained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline.DiscussionIf the study finds that the mailed distribution of free NRT is effective at promoting long-term cessation, it would provide further evidence to move forward with policies designed to make NRT treatment readily and freely available to smokers who request it.Trial registrationClinicalTrials.gov : NCT01429129 , Registered 2 September 2011; NCT03097445 , Registered 25 March 2017.

Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

Project description:IntroductionFaced with costly hospital readmissions of increasingly complex patient populations, transitional care is a priority throughout Ontario, Canada; yet, rural patients have significantly more hospital readmissions and emergency department visits during the first 30 days following hospitalisation than urban patients. Because transitional care (TC) was designed and evaluated with urban patients, addressing urban-rural disparities in TC effectiveness requires increasing the alignment of TC with the needs of patients and families in rural communities and the rural nursing practice context. The study objectives are to (1) determine the perceived acceptability of evidence-based TC interventions targeting postdischarge care management to patients, families and nurses and (2) adapt the interventions to patients' and families' needs and the rural nursing practice context.Methods and analysisThis multimethod study has two phases. In phase I, 32-48 patients and families will rate their level of preparedness for discharge and the acceptability of evidence-based TC interventions. Participants will be engaged in semi-structured interviews about their care management needs, their perspectives on the interventions in fitting those needs and in providing suggestions for adapting the interventions to fit their needs. TC interventions perceived as acceptable to patients and families will be examined in phase II. In phase II, 32-48 hospital and home care nurses will rate the acceptability of the interventions identified by patients and families and attend focus group discussions on the feasibility of providing the interventions. Phase I and II data will be analysed using descriptive statistics and qualitative content analysis.Ethics and disseminationEthics approval was obtained from the Research Ethics Board at York University and participating hospital sites. Findings will be communicated through plain language fact sheets, policy briefs, press-releases and peer-reviewed conference presentations and manuscripts.

Project description:ObjectiveTo assess whether offering free mailed nicotine replacement therapy (NRT) and telephone counselling to smokers on elective surgery waiting lists increases quitting before surgery.Design, settingRandomised, controlled trial at Frankston Hospital, a public tertiary referral hospital in Melbourne.ParticipantsAdult smokers added to elective surgery waiting lists for operations at least ten days in the future, 1 April 2019 - 3 April 2020.InterventionIn addition to normal care, intervention participants received a brochure on the risks of low frequency smoking, an offer of Quitline call-back registration, and an offer of mailed NRT according to reported daily smoking: 1-9 cigarettes/day, 2 mg lozenges; 10-15/day, 7-14 mg patches [three weeks] and 2 mg lozenges; > 15/day, 7-21 mg patches [five weeks] and 2 mg lozenges.Main outcome measuresPrimary outcome: quitting at least 24 hours before surgery, verified by exhaled carbon monoxide testing.Secondary outcomesquitting at least four weeks before surgery, adverse events, and (for those who had quit before surgery) abstinence three months after surgery.ResultsOf 748 eligible participants (control, 363; intervention, 385), 516 (69%) had undergone elective surgery when the trial was terminated early (for COVID-19-related reasons) (intervention group, 274; control group, 242). 122 of the 385 intervention participants (32%) had accepted the offer of cessation support. The proportions of intervention participants who quit at least 24 hours before surgery (18% v 9%; odds ratio [OR], 1.97; 95% CI, 1.22-3.15) or at least four weeks before surgery (9% v 4%; OR, 2.20; 95% CI, 1.08-4.50) were larger than for the control group. Three months after surgery, 27 of 58 intervention (47%) and 12 of 25 control participants (48%) who quit before surgery reported not smoking in the preceding seven days. No major adverse events were reported.ConclusionUptake of free mailed NRT and Quitline support by smokers on elective surgery waiting lists was good, and offering additional support was associated with higher proportions of smokers quitting before surgery.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12619000032156 (prospective).

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Targeting mailed nicotine patch distribution interventions to rural regions of Canada: protocol for a randomized controlled trial.

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Targeting mailed nicotine patch distribution interventions to rural regions of Canada: protocol for a randomized controlled trial.

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