A quasi-experimental, mixed-methods evaluation of the impact of transitioning to remote clinic visits in a smoking cessation trial during the SARS coronavirus-2 pandemic (Preprint)
BACKGROUND The SARS-2-coronavirus (aka covid-19) pandemic caused disruptions in ongoing clinical trials and likely accelerated interest in conducting research studies remotely. OBJECTIVE A quasi-experimental, mixed method approach was utilized to examine the opinions and experiences of participants enrolled in an on-going clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or phone 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 calendar years 2018 & 2019 (n=51, pre-covid-19 cohort) to examine rates for 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, 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% of salvia 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 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 might impact study outcomes. CLINICALTRIAL This research was supported in part by the National Cancer Institute (R01 CA206193); additional research infrastructure support was provided by the National Center for Advancing Translational Sciences/NIH (UL1TR001412) to the University at Buffalo.