Transitioning to Remote Clinic Visits in a Smoking Cessation Trial During the COVID-19 Pandemic: Mixed Methods Evaluation

Abstract

Background:The 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.Objective: A 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.Methods: For 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.Results: Participants 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. Conclusions:Even 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.

Opportunistic Non-Governmental Organisation Delivery of a Virtual Stop Smoking Service in England during the COVID-19 Lockdown

“…Very few participants took up the option of video calls; however, given that the service was offered in the earlier stages of the pandemic, it is possible that, as has been seen by local services [5], increasing confidence in video call technology would have seen greater uptake with time. Many participants identified building a relationship with a single allocated SCP was key to making a successful quit attempt, which may be more important than the choice of virtual platform [11].…”

“…A 2019 systematic review found moderate-certainty evidence that proactive telephone counselling helps smokers to quit smoking, but insufficient evidence to assess whether telephone counselling provided as an adjunct to other smoking cessation therapies has any additional effect [9]. There are promising signs that remote cessation services operated with some success in the pandemic; for example, studies required to change interventions from faceto-face behavioural support to remote behavioural support due to the pandemic found that quit rates [10] and clinic visits [11] for those in the intervention arm were similar for face-to-face and remote delivery. In Canada, it was found that the move to phone-based care for smoking cessation for cancer patients during the COVID-19 pandemic sometimes decreased counselling interruptions and improved follow-up rates [7].…”

Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study

“…While remote trials may alleviate structural barriers by allowing flexibility based on personal availability, TestBoston participants highlighted work and family obligations, time, and scheduling constraints that conflicted with sample return, as significant barriers. Other potential gaps that have been described include technology access, literacy and privacy concerns that may be unaddressed, and at worst, exacerbated by remote models [ 14 , 40 – 43 ]. We attempted to mitigate these factors by providing translation services, intense participant support, and participant-informed adaptations.…”

Telemedicine in the treatment of addictions

“…In a mixed-methods analysis, Mahoney et al [31] concluded that although the transition was not thoroughly planned but in many cases improvised to deliver phone or video call counseling, it contributed to keep the rates of appointments and collection of saliva samples at the same level as before the pandemic. During the lockdown, participants attended 83.6% of their remote visits and returned 93.2% of the saliva samples.…”