Empowering smokers with a web-assisted tobacco intervention to use prescription smoking cessation medications: a feasibility trial

Abstract

BackgroundVarenicline and bupropion, efficacious smoking cessation medications, have had suboptimal impact due to barriers at the patient, practitioner and system level. This study explored the feasibility of a web-assisted tobacco intervention offering free prescription smoking cessation medication by mail if the smoker visited a physician for authorization.MethodsAdult Ontarians, smoking at least 10 cigarettes daily, intending to quit within 30 days, with no contraindications to bupropion or varenicline were eligible. After an online assessment, eligible participants received an electronic personalized printable prescription form for a 12-week course of varenicline or bupropion to bring to a physician within 3 weeks for authorization, if appropriate. The physician’s office faxed prescriptions to an online pharmacy that couriered medication to the patient following medication counselling by telephone. Weekly motivational emails were sent during treatment. Participants were asked to complete follow-up questionnaires online at 7, 11, 15 and 41 weeks after enrollment.ResultsIn total, 1214 individuals submitted an online assessment from April to September 2010 and 73.6 % (95 % confidence interval (CI) = 71.1–76.1 %; n = 893) were eligible. At least 65.8 % (95 % CI = 62.7–68.9 %; n = 588) of eligible participants subsequently visited a physician and 58.7 % (95 % CI = 55.5–61.9 %; n = 524) received medication (50.6 % varenicline [n = 265] and 49.4 % bupropion [n = 259]). Reasons for not filling a prescription were failure to visit a physician (80.1 %; 95 % CI = 73.8–86.5 %; n = 121), physician not prescribing the medication (15.9 %; 95 % CI = 10.1–21.7 %; n = 24) or other reasons (4.0 %; 95 % CI = 0.9–7.1 %; n = 6). Follow-up response rate was 66.7 % (95 % CI = 63.7–69.8 %; n = 596). Minimal issues were encountered with printing the prescription or medication delivery.ConclusionsThis study establishes the feasibility of using the Internet and free medication to enable smokers to engage physicians to treat this addiction. Implementation of this intervention can be scaled up by leveraging existing healthcare systems to treat smokers on a population level. Further evaluation in a randomized controlled trial is necessary.Trial registrationClinicalTrials.gov Identifier NCT01023659Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-015-0329-7) contains supplementary material, which is available to authorized users.

Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial

“…To be sufficiently powered to detect a significant difference in the 26-week CARs, we plan to randomize 500 subjects to each medication arm. We predict that the real-world abstinence rates will be slightly lower than those observed in clinical trials and may be similar to what we found in our nonrandomized study that this protocol is based on [ 19 ]. Therefore, we assumed that the 26-week CAR in the varenicline-treated group would be 20% compared with 15% in the bupropion-treated group.…”

A digital solution to streamline access to smoking cessation interventions in England; findings from a primary care pilot (STOPNOW study)

“…Whereas smoking is the major avoidable cause of preventable morbidity and mortality in the UK and internationally, there are surprisingly few examples of a patient-facing primary care led IT system to streamline the delivery of evidence based smoking cessation interventions in the community setting [ 22 , [33] , [34] , [35] ]. The aim of this study was to investigate the efficacy of a patient-facing portal to streamline timely access to pharmacological support to smokers who want to quit by making an asynchronous request for treatment with their designated NHS primary care provider.…”

“…All 56 participants who completed the questionnaire and requested suitable treatment options were prescribed their preferred choice of intervention suggesting a high level of acceptability of the algorithm and the functionality of the STOPNOW portal. As with the tool previously developed by Selby et al [ 35 ], the portal included a series of automated a priori procedures that blocked multiple or incongruent resubmissions by the same patient, including conditional checkpoints and digital identifiers that ensured a patient who did not pick up the first prescription cannot re-enter the pathway in error or make another new request for treatment. Despite these features, the vast majority of patients who made a congruent formal request for treatment and who were prescribed pharmacological support or NRT via EPS did not pick up their medication.…”

Direct‐to‐participant investigational medicinal product supply in clinical trials in Europe: Exploring the experiences of sponsors, site staff and couriers

“…DtP supply has been used previously in a diverse set of clinical trials, [15][16][17][18][19][20][21][22][23] including trials to evaluate drugs for Alzheimer's disease 16 and antithrombotic therapies in patients with Covid-19 17 and to investigate drug adherence. 18 In line with the results of the current study, DtP IMP solutions are reported to be advantageous in clinical trials because of a "geographically dispersed rare population", as well as being more convenient for participants' daily lives, 16 enabling more pragmatic 19,20 and decentralized 21 trial approaches, limiting inperson interactions and thus allowing participants to quarantine during the Covid-19 pandemic, 17 facilitating the inclusion of a large number of physicians and patients, 22 decreasing the workload of the site study staff and minimizing potential interruptions in the treatment course. 23 Although DtP IMP supply has been reported throughout different phases of clinical development, 24 not all types of IMP may be suitable for DtP shipment, such as products with an unknown safety profile, complex route of administration or strict cold chain requirement.…”